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Enterprise Archive should be more than a Long-term Storage Solution

The original concept of the Enterprise Archive was to provide a centralized long-term storage solution for multiple department PACS, like Radiology, Cardiology, etc. Deploying the individual "archives" incorporated into each of the Health System's department PACS often requires supporting multiple technologies. That and the obvious redundancy means higher cost of ownership. Several years ago, the simple solution was to deploy a single storage solution that could be shared by the various department PACS, and with a growing number of Radiology and Cardiology PACS vendors supporting open storage solutions, this simple solution was a reasonable solution.

While this solution reduced some of the redundancy, it did nothing to standardize the data. As more and more Health Systems began to realize that replacement of an old PACS with a new PACS required a migration of the data to the new PACS, it became obvious that a solution was also required to address this problem. Thus the original concept of the Enterprise Archive was modified to include a solution to the expensive and painful problem of data migration.

A storage solution alone is not equipped to handle the data migration issue. The management of Radiology and Cardiology data objects requires a feature-rich layer of DICOM services on top of the storage solution. More specifically a DICOM service is required to convert the idiosyncrasies in the DICOM format used by vendor A into the idiosyncrasies in the DICOM format used by vendor B. Simply put, the tools typically used by the data migration service organizations to migrate data from PACS A to PACS B would need to be integrated into the DICOM services package that sits on top of the storage solution. The common term for this format conversion is Tag Morphing. The integration of Tag Morphing into the DICOM layer of a storage solution would enable any PACS to forward image data to this storage solution as well as retrieve image data deposited by itself or any other PACS.

Tag Morphing eliminates the need for future data migration, and Tag Morphing enables data exchange between disparate PACS. Hence the term PACS-Neutral Archive.

The evolution from shared storage solution to PACS-Neutral Archive was a pretty nifty evolution in concept, and it was clearly the genesis of an emerging new segment of the image management market. There are at least six vendors in the United States that offer a product that meets the basic requirements of a PACS-Neutral Archive: Acuo Technologies, Agfa Healthcare, DeJarnette Research, Emageon, InSiteOne, and TeraMedica. There are already several installations of such systems in the United States, and several more in Europe.

But the Enterprise Archive needs to be more than a PACS-Neutral Archive.

Several years ago the concept of accessing image data through the Electronic Medical Record (EMR) was popularized. Then and now, the concept of an EMR is that the vast majority of physicians in a Health System would post their charts and research their patient's study results in the EMR. Therefore it would be convenient if they could access the images associated with those results while remaining in the EMR application. To date EMR products do not include the specialized viewer software required to view Radiology, Cardiology, Ophthalmology, etc. images. Furthermore the EMR is not typically configured with the volume of digital storage required to store a copy of all of these modality images. Instead of incorporating the Image Viewer in the EMR and instead of creating yet another image data repository in the EMR, a much better solution has evolved. A URL interface links the patient study instance in the EMR to the corresponding Department PACS that provides the long-term digital archiving of the study data, as well as the viewing application for the display of the images. The EMR user clicks on a study listed in the EMR and a link takes the user directly to the PACS where the images related to that study are being archived. The viewing application is the same viewer that would otherwise be accessed if the user logged directly into the department PACS. In this case, the user has the benefit of using the department PACS without having to really leave the EMR environment.

This approach is really a major step forward in information access, but it didn't take long to foresee two significant problems. First, enterprises with multiple department PACS would have to support separate URL links between the EMR and each of those PACS. In really large Enterprises, the number of separate PACS is a big number. Second, the physicians who choose to view images from within the EMR application have to learn how to use multiple viewers, each supported by the different PACS.

A PACS-Neutral Archive can obviously become the EMR Data Repository, as it is the single enterprise archive where all image data from all PACS is stored. But the PACS-Neutral Archive alone is not equipped to provide the EMR with a viewing application. Archives are typically not expected to support a viewing application, but that is exactly what is needed to solve this new problem. The ideal Enterprise Archive would first of all be a PACS-Neutral Archive and therefore be the EMR data repository, and secondly it must support a thin client or web-delivered image viewing application that could display any of the image objects that have been committed to the Enterprise Archive. The trick of course is being able to display different types of images (Radiology, Cardiology, Pathology, Visible Light, etc.) with the same viewing software, maybe on the same display screen and in the same working session. This would be the ultimate multi-modality medical image viewer!

The PACS-Neutral Enterprise Archive configured with a Multi-modality Viewer for the EMR would be extremely useful to even a small enterprise. But there are still more key issues that need to be resolved before one could accurately describe this new kind of Archive. What kind of data objects can it accept? How does it treat different types of data objects? Does every object have to be DICOM? What display feature set is appropriate for the EMR user? Interestingly enough, all of these issues are inter-related, and there is a significant difference of opinion on these issues among the developers of the new Enterprise Archive. In my next post, I'll present some interesting positions on these issues and attempt to defend my own personal opinions.


Read more [Gray Consulting]

Laser Opto-Acoustic Imaging Technology from Seno Medical

Here's what we know about the opto-acoustic imaging technology from Seno Medical Instruments, Inc., a San Antonio, Texas firm. A recent report on the wires says that there is a new research agreement between Seno Medical and two Canadian universities to study the company's first-ever commercially available opto-acoustic small animal imaging device. It turns out the technology, that utilizes the conversion of laser pulses into acoustic energy once the light hits tissue, can have profound consequences on development of future diagnostic imaging modalities for cancer and beyond. The company explains its technology: Laser opto-acoustic imaging technology combines optics and acoustics with a goal of improving the accuracy of the cancer diagnosis without the use of ionizing radiation (x-ray). The process starts by illuminating the breast with laser light of specific wavelengths. Tumors preferentially absorb the light over normal tissue and become slightly heated. A transient thermoelastic expansion causes a tumor to emit a pressure (acoustic) wave. This acoustic wave is then detected by an array of sensors positioned around the periphery of the breast held within the probe. Signals from the sensors are analyzed and assembled into high contrast, high-resolution images that present the lesion in striking color. Because image contrast is related to both blood volume and oxygenation status, lesions may be correlated with benign or malignant histopathology. This is because malignant tumors possess increased microvasculature, but deplete oxygen from the blood at a higher rate than benign growths. Deoxygenated blood results in brighter images in the presence of a shorter wavelength than it does in the presence of a longer wavelength. This technology has the merit of both the high contrast and spectral specificity of optical imaging and the sensitivity and resolution of ultrasonic imaging. It is more than just a combination of the two methods. The goal is to incorporate laser illumination and ultrasonic detection to achieve very high detection sensitivity. Laser opto-acoustic imaging may permit the identification of tumors as small as 2 mm and has demonstrated the ability to see submillimeter structures. Early detection is important because biologically advanced tumors are more capable of metastasis. Technology page @ Seno Medical: Laser Opto-Acoustic Imaging... Press release: Seno Medical Instruments Launches First-Ever Commercially Available Opto-Acoustic Small Animal Imaging Research System... Flashbacks: Optoacoustic Technology for Early Cancer Detection... Michael
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Vendor Notebook - Eclipsys rolls out LIS at Minn. hospital

The Eclipsys Corporation has announced that North Memorial Health Care has selected the Eclipsys Laboratory Information System (LIS) to streamline enterprise efficiencies and communication across inpatient and outpatient settings. Read about this and other business news, contracts and new products in this week's Vendor Notebook.
Read more [Healthcare IT News]

New Client Signs for Eclipsys' Lab

North Memorial Health Care in Robbinsdale, Minn., which includes a 518-bed hospital, will implement the Sunrise laboratory information system from Eclipsys Corp., Atlanta.
Read more [Health Data management Online Current News]

2009 Joint Commission Standards: Now Available Online

The Joint Commission's revised standards are now available online. Additional details about the revisions are available on the Standards Improvement Initiative web page.

The timetable for the release of the new standards, manuals and scoring information is as follows:

• July 2008: Standards will be posted to The Joint Commission website
• August 2008: Scoring information will be posted to the website
• September 2008: Hard copy manuals will be available for Phase 1 programs (ambulatory, hospital, critical access hospital, home care, office-based surgery)
• November 2008: Hard copy manuals will be available for Phase 2 programs (behavioral health care, laboratory services, long term care)*
• November 2008: Single-user access to E-dition (electronic manuals) will be available for all accreditation customers.
  

Killing Bugs With E&M

At Georgia Tech Research Institute a new device tuned to kill biological contaminants has been created. Using specific phosphors that emit UV light via cathodoluminescence effect, the device kills tiny critters on surfaces and within. From Georgia Tech: Using flat panel modules that produce X-rays and ultraviolet-C (UV-C) light simultaneously, the researchers can kill anthrax spores in two to three hours without any lingering effects. The system also has the ability to kill anthrax spores hidden in places like computer keyboards without causing damage. "This is certainly an improvement over previous techniques," said Brent Wagner, GTRI principal research scientist and director of its Phosphor Technology Center of Excellence (PTCOE). "The UV-C attacks spores on surfaces and the X-rays penetrate through materials and kill spores in cracks and crevices." The new decontamination system resembles a coat rack with radiation modules arranged on rings at various heights that face outward to broadcast radiation throughout a room. Since the X-rays and UV-C are lethal at the flux densities used, the system operates unattended and is turned on outside the affected space. UV-C light in the modules is produced using the optical and electrical phenomenon of cathodoluminescence. Numerous electron beams are generated by arrays of cold cathodes, each acting like the electron gun in a cathode ray tube. "When an electron beam hits a powder phosphor, it luminesces and emits visible and/or non-visible light," explained Hisham Menkara, a senior research scientist in GTRI’s Electro-Optical Systems Laboratory. With the Sarnoff phosphors in hand, Wagner and Menkara set off to determine the best UV-C emitting phosphor and optimize its properties for use with X-rays in SMD’s small flat panel display. To find the best phosphor that emitted light in the UV-C region of the spectrum – wavelengths below 280 nanometers – the emission spectra of each phosphor was measured against the DNA absorption curve. This curve shows the optimal wavelengths to destroy an organism’s DNA. After investigating many different phosphors, the researchers chose lanthanum phosphate:praseodymium (LaPO4:Pr or LAP:Pr) as the most efficient phosphor, with a power efficiency near 10 percent. Since the UV emission didn’t fall completely under the DNA absorption curve, the relative “killing efficiency” was approximately 50 percent. In the laboratory, Menkara created the phosphor by mixing precursors lanthanum oxide, hydrogen phosphate and praseodymium fluoride (La2O3, H3PO4 and PrF3, respectively) in a glass beaker with methanol (CH3OH) and ammonium chloride (NH4Cl). Air drying the... Michael
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Implantable Heart Monitor May Provide Real Time Cardiac Data

Imperial College London researchers have developed an implantable cardiac monitor that supposedly can detect changes in cardiac contractility, hence can function as a continuous (and also wireless) heart failure monitor. From the press release: The sensor is constructed from silicon and vibrates at a rate which varies according to the pressure inside the heart. Once at home, patients would wear a reader, a miniature device that detects these vibrations through radio pulses, and translates them into precise measurements. Patients would be able view their own readings at home via the reader, while doctors could take measurements by dialling up the reader via a mobile phone or by logging onto a secure internet site. The reader could also be set to automatically send alarms to the doctor if a patient’s heart reading reaches critical levels. Lead researcher, Professor Christofer Toumazou, from Imperial College London’s Institute of Biomedical Engineering, says: “The heart pressure sensor could transform the lives of people living with chronic heart problems and has the potential to revolutionise heart monitoring. At the touch of a few buttons a family doctor could dial up their patient’s heart history and plot pressure trends to better manage their condition and prevent the progression of heart failure.” Sir Magdi Yacoub, Professor of Cardiothoracic Surgery at Imperial College London, has trialled the pressure sensor successfully on animal laboratory models. Press release: Implantable sensor will revolutionise the management of heart disease, say Imperial researchers ...... Michael
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Twin City area hospital implements lab information system

North Memorial Health Care, an independent hospital covering Minnesota's Twin Cities area, will implement a laboratory information solution from Eclipsys in an effort to streamline enterprise efficiencies and communication across inpatient and outpatient settings.
Read more [Healthcare IT News]

Nerve Cells Made from Stem Cells Successfully Transplanted

Researchers at the Burnham Institute for Medical Research in La Jolla, CA have for the first time converted stem cells to nerve cells, and implanted them into mice. The transplantation and accommodation of these cells was successful, and the scientists did not get into the common problems associated with transplanted cells, such as resulting formation of tumors. Prior to this research, creating pure neuronal cells from ES cells had been problematic as the cells did not always differentiate into neurons. Sometimes they became glial cells, which lack many of the neurons’ desirable properties. Even when the neuronal cells were created successfully, they often died in the brain following transplant—a process called programmed cell death or apoptosis. In addition, the cells would sometimes become tumors. Dr. Lipton solved these problems by inducing ES cells to express a protein, discovered in his laboratory called myocyte enhancer factor 2C (MEF2C). MEF2C is a transcription factor that turns on specific genes which then drive stem cells to become nerve cells. Using MEF2C, the researchers created colonies of pure neuronal progenitor cells, a stage of development that occurs before becoming a nerve cell, with no tumors. These cells were then transplanted into the brain and later became adult nerve cells. MEF2C also protected the cells from apoptosis once inside the brain. “To move forward with stem cell-based therapies, we need to have a reliable source of nerve cells that can be easily grown, differentiate in the way that we want them to and remain viable after transplantation,” said Dr. Lipton. “MEF2C helps this process first by turning on the genes that, when expressed, make stem cells into nerve cells. It then turns on other genes that keep those new nerve cells from dying. As a result, we were able to produce neuronal progenitor cells that differentiate into a virtually pure population of neurons and survive inside the brain.” The next step was to determine whether the transplanted neural progenitor cells became nerve cells that integrated into the existing network of nerve cells in the brain. Performing intricate electrical studies, Dr. Lipton’s investigative team showed that the new nerve cells, derived from the stem cells, could send and receive proper electrical signals to the rest of the brain. They then determined if the new cells could provide cognitive benefits to the stroke-afflicted mice. The team executed a battery of neurobehavioral tests and found that the... Michael
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Zinc Finger DNA-Binding Protein Technology Gives T-Cells Shield Against HIV

Sangamo BioSciences, Inc., based in Richmond, California, is reporting positive news showing that CD4 T-cells can be made HIV resistant with the help of the company's proprietary zinc finger DNA-binding protein nucleases (ZFN), specially developed transcription factors. From Sangamo: Sangamo's ZFNs are designed to permanently modify the DNA sequence encoding CCR5, a co-receptor that enables HIV to enter and infect cells of the immune system. Individuals carrying a naturally occurring mutation of their CCR5 gene, a variant known as CCR5-delta32, have been shown to be resistant to HIV infection. "The data described in this paper are an important demonstration of the potential therapeutic properties of our product," commented Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer. "We have demonstrated that a single treatment with our CCR5-specific ZFNs generates a population of HIV-resistant human T-cells similar to the situation in individuals carrying the natural CCR5-delta32 mutation. ZFN-modification of these cells is permanent and makes them resistant to HIV. The modified cells preferentially survive and expand in an animal after HIV infection, providing a reservoir of healthy and uninfectable immune cells. Furthermore, we observed that animals given the ZFN-modified cells had increased numbers of CD4 cells and substantially lower levels of HIV in their blood compared to animals given non-modified cells demonstrating statistically significant protection from the virus. In an HIV-infected patient, such modified cells could be available as a protected reservoir within the immune system to fight both opportunistic infections and HIV itself." Several major pharmaceutical companies have initiated programs to develop small molecule or monoclonal antibody approaches to block the binding of HIV to CCR5. However, a small molecule or antibody approach requires the constant presence of a sufficiently high concentration of these drugs or antibody to block therapeutically relevant numbers of the CCR5 protein, which is present in thousands of copies on the surface of each T-cell and other tissues in the body. One such drug has been approved by the US Food and Drug Administration with a "black box" warning, the strongest for prescription drugs, concerning the risk of liver toxicity and the possibility of heart attacks. Sangamo's ZFN technology represents a means of potentially circumventing these limitations or risks by specifically modifying only CD4 T-cells, the principal target of HIV pathology, in a one-time exposure of the cells to ZFNs. This results in permanent modification of the CCR5 protein such that HIV... Michael
Read more [Medgadget]

"Eminence-Based" Surgical Pathology and the Digital Pathology Department

In a recent note, I commented on the new strategic alliance between GE Medical and the University of Pittsburgh Medical Center (UPMC) in the pursuit of the digital pathology department and whole slide imaging (see: GE Medical Partners with UPMC in Pathology Imaging Venture). It is often stated that digital radiology took about a decade to mature and that digital pathology will take an equal amount of time to become the accepted standard of practice. However, major incentives were available in the conversion to digital radiology such as the ability to offer new imaging procedures with attractive profit margins plus a groundswell of enthusiasm on the part of hospital clinicians for these new offerings. These same incentives do not exist for digital pathology -- there are no additional profit margins to be gained for the hospital and the pathology reports to clinicians are largely the same except for the routine integration of digital images into surgical pathology reports.

However, it you are searching for a "killer app" associated with digital pathology, it is most certainly image search. By this I mean the ability to isolate "fields of interest" in a challenging surgical pathology case, an unusual malignant tumor for instance, and then match them against a large image database of diagnosed lesions for similar lesions. For challenging cases today, this same process often takes place laboriously by searching surgical pathology atlases on the shelf. Parallel to this process, many such cases are also referred to local colleagues for their opinions and also sent to "marquee" surgical pathologists who have established reputations as having superb diagnostic skills in various specialty areas. This is the basis for what has been called eminence-based surgical pathology.

And now comes the rub. These marquee pathologists have little to gain and much to loose by the introduction of digital pathology and image searches. Image searches and pattern matching is, in fact, what is taking place in the brains of these eminent pathologists. I suspect that they will have little enthusiasm for any technology that serves to lessen their influence, prestige, and livelihood. Many of these latter pathologists are also highly placed in the hierarchy of prestigious pathology departments. I suspect that they will be leaders of the chorus opposing the conversion to digital pathology and perhaps highlighting the failures and inadequacies of digital pathology departments.

The Evolution of Integrated Diagnostics into Integrated Diagnostic Centers

In a recent post (see: A Call for the Development of Integrated Diagnostic Centers), I posted an abstract of a lecture that I will be delivering at the 42nd annual Congress of the Brazilian Society of Clinical Pathology (Sociedade Brasileira de Patologia Clínica; SBPC) on July 3, 2008, in Sao Paulo, Brazil. In it I emphasize the idea that pathologists, lab medicine specialists, and radiologists should collaborate to develop physical or virtual integrated diagnostic centers (IDCs) to which patients can be referred with early symptoms of disease or for wellness/preventive medicine consultations. In these centers, diagnostic specialists would use the most advanced imaging modalities and in-vitro laboratory testing to quickly arrive at the correct diagnosis. These patients would then be referred to clinicians for treatment. This idea is the logical outgrowth of the concept of integrated diagnostics (see: Siemens' Pursuit of an Integrated Diagnostics Portfolio) and the early health model, both of which have been addressed extensively in Lab Soft News. It is also closely related to the merger/conversion of pathology, radiology, and lab medicine into the new specialty of diagnostic medicine. I am now posting the entire lecture here (see: Integrated Diagnostics Emerges as Key Element in Healthcare) and would welcome any comments from readers about any of the ideas contained in it.

New Health Informatics Research Lab

Swansea University have launched a research laboratory, which will help find innovative new ways of treating patients, by simulating a range of healthcare settings experienced by patients so that innovative new technology can be tested before being introduced. The laboratory aims to: * use the latest technology to evaluate new ideas and treatment methods and work with current computer systems inRodhttp://www.blogger.com/profile/12607263970096550308noreply@blogger.com
Read more [Informaticopia]

Indian Clinical Lab Penalized by Government for Late Report

Late lab reports can be problematic for both clinicians and their patients. As a result, all of the lab professionals that I know place a very high premium on test result rapid reporting. Nevertheless, I was a little shocked to read about the Indian government levying a fine against a clinical lab for a late report (see: Lab fined for late report that led to death). Below is the story with boldface emphasis mine:

The state consumer commission has pulled up a specialty laboratory for inordinate delay in sending a patient’s report to a hospital, as a result of which he died. The lab report for a CMV test — carried out for viral detection — was crucial for the treatment of a 56-year-old patient, who was awaiting a renal transplantation. It took the laboratory 25 days to send the report, by which time the patient died. Now, the commission has asked the lab, Speciality Ranbaxy Limited, to pay Rs 50,000 as compensation to the victim’s family....The patient, V K Garg, had been admitted to AIIMS [All India Institute of Medical Sciences] on June 1, 1999 for a renal transplant. As his CMV test reports from two pathological labs gave conflicting results, doctors advised him to go for another CMV test from Speciality Ranbaxy Ltd. Accordingly, his blood sample was sent for testing on June 17, 1999, and the laboratory at Yusuf Sarai market assured to deliver the report on or before July 3. But the lab failed to deliver on the promise — despite a written reminder — Garg’s treatment could not begin and he died on July 13. In fact, the report was only prepared on July 14 and dispatched on July 17, with a remark that the report was delayed owing to a problem in laboratory information system at Specialty Laboratories, Inc, USA. While denying allegations of deficiency in service, the laboratory cited this technical problem for failing to deliver the report on time. It added: "The record showed that doctors at AIIMS continued with the treatment."

Oh, give me a break. Blame a late report on the LIS and particularly one installed in a U.S. reference lab. However, this story gets a little confusing, involving both Specialty Ranbaxy Lab in India and Specialty Laboratories in the U.S. It appears that this latter lab was used to try to break the initial CMV assay tie with a specimen turfed to it from Ranbaxy in India. I must also strongly express my preference for the use of the term pathology lab rather than pathological lab as used in the article above, although the later may sometimes be more apt. What is also interesting about this story is that the patient, V.K. Garg, was tasked with shopping around his own specimen in order to reconcile the conflicting CMV results.

Who "Owns" PACS: Radiology or Central IT in Hospitals?

Veteran readers of this blog will probably know that I am a strong proponent of having laboratory professionals "manage" their own LISs. Lab tests results are a strategic asset in hospitals, underlying about 70% of hospital diagnoses and constituting about 70% of the data contained in electronic medical records. How does one determine who manages (i.e., owns) the LIS? Easy! Who makes the decisions regarding access to lab information? Who formats that information? Who has the final word on policy issues regarding that information. Who has both de jure and de facto control (i.e., stewardship) over it? If you need to pull out an org chart to answer these questions, you are in trouble. Needless to say, I was interested in a recent article (see: Who owns PACS -- Radiology or IT?) about this same question as it applies to radiology information and images. Below is a longish excerpt from the article with boldface emphasis mine:

Should radiology or the IT department take responsibility for managing PACS in a hospital? It depends on the facility's corporate culture and the level of sophistication of the IT department, an animated "debate" at the 2008 Society for Imaging Informatics in Medicine (SIIM) meeting concluded. The premise of the argument presented by Dr. Paul J. Chang on behalf of IT department ownership is that PACS technology has become a component of the entire hospital informatics enterprise rather than its own unique entity. In an increasing number of hospital infrastructures, dedicated networks for PACS are unnecessary. Thick-client workstations are facing obsolescence....Modern healthcare IT should be structured as a matrix, according to Chang, who straddles both worlds as vice chairman of radiology informatics and director of pathology informatics at the University of Chicago Pritzker School of Medicine....Because PACS is the multimedia component of an electronic health record (EHR), the EHR must be optimized to support radiology workflow. Not only is this a complex undertaking, but it logically fits as the responsibility of the IT department -- as long as the IT department has a global vision and a progressive philosophy, Chang said.

Dr. David Channin, chief of imaging informatics at Northwestern Memorial Hospital and the Feinberg School of Medicine in Chicago, disagreed. "Radiology has led informatics technology innovation in hospitals and will continue to be the source of informatics leadership in healthcare," Channin said. "Domain expertise must take precedence over IT expertise. Tools don't drive domain innovation. If controlled in a central manner, such as a matrix structure, the priorities of a radiology department will be subjected to control by an IT department juggling priorities representing multiple domains in a hospital," he said. "If you don't have budgetary control of your bucket of allocated capital dollars, you have lost control. Your critically needed PACS upgrade will be competing with acquisition of a new laser doodad for OR." Radiology departments should wield the power they have as cash cows for hospitals, define their IT domain borders, provide access to them with standard interfaces, and demand autonomy, according to Channin. He recommended that radiology departments contract with IT departments for "commodity services" such as networks, virtual operating systems, and data storage.

Well, no one can say that Drs. Chang  and Channin did not speak their minds in this spirited exchange. There is too much interesting material here to cover at one time. Here are some of my initial reactions:

• Matrix shamtrix. You either own the LIS/RIS/PACS or you don't. See my discussion above about system management/ownership. Pathology owns (or should own) lab information and pathology images and radiology owns (or should own) radiology information and images. Central IT + clinical personnel should then negotiate with pathology and radiology for access to the information managed by the latter two groups.
• According to Dr. Channin, "radiology has led informatics technology innovation in hospitals." LISs were developed and commercialized in the late 1970s and thus preceded RISs by at least five years in hospitals. AIMCL, the LIS conference that preceded Lab InfoTech Summit, was launched in 1983. Radiologists are the acknowledged leaders in hospital image management and storage. Let's call it a draw.
• I agree with Dr. Channin regarding the IT capital and operating budget for the LIS and RIS. If you don't control the information system budget, you don't control the information system.
• I have no problem with the central IT departments providing "commodity services" to pathology and radiology. They are best able to provide institution-wide services like networks and generic data storage for the entire institution. However, I believe that the latter is now a commodity and best provided via a vertical cloud (see: A Closer Look at the Vertical Cloud in Healthcare Computing; The Potential for "Sereverless" Healthcare Computing).

Pathology Is Not Disintegrating in Canada!

Today's guest blog has been written by the very distinguished Canadian pathologist, Dr. Michael McNeely. Mike is currently the President of the Association for Pathology Informatics (API) and Past-President of the Canadian Association of Pathologists. He lives in Victoria, British Columbia, Canada.

No, Pathology in Canada is NOT “coming apart at the seams”.  Our country continues to enjoy exemplary clinical laboratory service. The situation is tight and, in certain instances, is dangerous.  Recent newsworthy events and an editorial in the CMAJ (see:  Canada's pathology) speak to two issues which I would like to clarify: (1) “lack of a national QA program” and (2) a shortage of laboratory professional staff.

Quality Assurance: This part of the report has caused some to believe that Canada does not use QA. This is clearly not correct. Although Canada has government-funded health care, each individual province is responsible for the administration and management of health care within its own jurisdiction. With some provincial variation, lab accreditation and mandatory QA has been standard across the country for 30+ years.  What has not been routinely available (until several recent notable projects were launched) has been scrutiny of the professional work of pathologists.  This has been compounded by situations where pathologists work alone. 

Professional Staffing: During the 1960s and early 70s, Canada was the beneficiary of an influx of highly trained pathologists from other countries (mainly the UK). This bolus took up the open positions but neutralized the need to develop a full stream of residents. Twenty-seven years ago (commenting on research conducted by the late Vern Waldorf), I wrote an editorial in the Canadian Association of Pathologists Newsletter (Vol 24: March 1982; p. 18) in which I stated “It is probable that retirement will produce a manpower shortage that will start in about five years and will reach crisis proportions around the year 2000.”  Since, the early 80s, medical school output was curtailed and pathology residencies not expanded to meet the declining requirements. Today, we are “holding on” but all groups are stretched thin and specific locations are inadequately serviced.

The Forward Thinking Brain

A team of U.S. and Canadian scientists claims to have used an MRI machine and a few monkeys to show that the reality that our consciousness perceives is just a little bit in the future, always having to predict what comes next. The research, among other things, may explain mental paradoxes we all experience, déjà vu being the best example. Work by Andersen, the James G. Boswell Professor of Neuroscience at Caltech, and his colleagues Grant Mulliken of MIT and Sam Musallam of McGill University, offers the first neural evidence that voluntary limb movements are guided by our brain's prediction of what will happen an instant into the future. "The brain is generating its own version of the world, a 'forward model,' which allows you to know where you actually are in real time. It takes the delays out of the system," Andersen says. The research in Andersen's laboratory is focused on understanding the neurobiological underpinnings of brain processes, including the senses of sight, hearing, balance, and touch, and the neural mechanisms of action. The lab is working toward the development of implanted neural prosthetic devices that would serve as an interface between severely paralyzed individuals' brain signals and their artificial limbs--allowing thoughts to control movement. In their experiments, Andersen and his colleagues trained two monkeys to use a joystick to move a cursor on a computer screen from a small red circle into a green circle, while keeping their gaze fixed on the red circle. The monkeys typically generated curved trajectories, but to increase the curvature one monkey was trained to move the cursor around an obstacle. The obstacle (a large blue circle) was placed between the initial location of the cursor and the target circle, and the monkey had to guide the cursor around the obstacle, without touching it, and over to the green circle. As the monkeys conducted the tasks, electrodes measured the activity of neurons in the PPC. This allowed Andersen and his colleagues to monitor signals--commands for movement--in real time. The studies showed that neurons in the PPC produce signals that represent the brain's estimation of the current and upcoming movement of the cursor. "An internal estimate of the current state of the cursor can be used immediately by the brain to rapidly correct a movement, avoiding having to rely entirely on late-arriving sensory information, which can result in slow and unstable control," Mulliken says.... Michael
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Nanolens for Subwavelength Spatial Resolution Microscopy

Michael Berger over at Nanowerk is reporting about the efforts of Japanese scientists at Osaka University and the Nanophotonics Laboratory at RIKEN Institute to develop a light microscope that uses silver nanorods to deliver magnifications of structures that are far below the spatial light resolution limit. In work that gives rise to a new concept of a lens for optical imaging, scientists in Japan have proposed a lens made of silver nanorods, rather than a curved glass surface. This metallic nanolens is capable of manipulating light in such a way that an optical image of nanoscale objects can be obtained in the visible range. "We have demonstrated that our nanolens can transfer color images of nanoscale objects over distances of at least micrometer scale with a sufficient amount of magnification for far-field observation" Dr. Prabhat Verma tells Nanowerk. "We believe that, in principle, the image can be transferred over even longer distances without any significant loss. The proposed nanolens could potentially be a strong imaging tool, for example, for observing individual viruses and other nano-entities in the far field." To learn about this technology idea, head on to the article at Nanowerk: Nanolens makes color imaging of nano objects possible... Abstract: Subwavelength colour imaging with a metallic nanolens Nature Photonics doi:10.1038/nphoton.2008.103... Michael
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Lab Services Group Gets New Software

ACL Laboratories will standardize on anatomic pathology software from Sunquest Information Systems Inc., Tucson, Ariz., at all of its facilities. The deal is estimated to be worth $4.6 million.
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The Goals of an LIS Compared to Goals of a Hospital EMR

Rob Bush of Orchard Software submitted a comment about a recent post (see: Cultural Barriers to Medical Innovation). His points were so interesting that I am promoting his comment to the level of a blog note, copying it below in its entirety (boldface emphasis mine):

Commenting on the success of the LIS vs the EMR:
The common objective of the laboratory is to provide accurate results in a timely and cost effective way. Everyone working in the lab can agree upon the goals, and behave as a part of the overall solution. The EMR’s goal is not that well defined. Although it is often stated to be improving healthcare for the patient, I believe the working goal is to make each healthcare professional using the system more efficient at doing their job. Naturally, if the goal is to make you personally more efficient, there is a different goal for each person using the EMR. The mentality of the people involved is very different. In the lab the people ask “What can I do to help with the process?” With the EMR, people ask “What can the software do to make me more efficient?”

I have some minor quibbles with Rob's comment but his overall logic is correct in my opinion. The overarching role of the LIS, and the clinical labs that it supports, is to provide accurate results to clinicians in a timely and cost effective way. Similarly, the role of the hospital EMR, and the physicians and nurses working in an inpatient unit, is to provide efficient and effective healthcare to patients admitted to that unit.

Both lab professionals and hospital nurses tend to operate as teams and emphasize teamwork. Both the LIS and EMR are tools to enhance the work of these teams. The role of physicians in hospitals is somewhat different and more attention needs to be paid to their individual responsibility and productivity. As proof of this statement, you need only recall the common conversations of hospitalized patients, who will often refer to "my surgeon" or "my anesthesiologist." The pathologist plays a critical role in the care of a patient in the diagnosis of disease but their role is largely anonymous. Few patients will will make reference to "my pathologist."

So what can we make of all of this? Only that the EMR must serve to increase the productivity of all of the various teams in a hospital, including lab professionals, but also the individual productivity of physicians working in the same environment. Failure to do so will result in opposition from the physicians and I will defend their right to take such a position.

A Call for the Development of Integrated Diagnostic Centers

I will be delivering a lecture to the 42nd annual Congress of the Brazilian Society of Clinical Pathology (Sociedade Brasileira de Patologia Clínica; SBPC) on July 3, 2008, in Sao Paulo, Brazil. The lecture is entitled "Integrated Diagnostics Emerges as a Key Element in Healthcare." The lecture will address the development of integrated diagnostic centers (IDCs) which I believe will play an important role in the future of healthcare delivery. Below is a summary of this presentation that I was asked to write for the SBPC web site.

The general field of diagnostics, with molecular diagnostics and medical imaging at its core, is undergoing an explosion of knowledge providing the potential to diagnose disease in its pre-clinical pre-symptomatic stage before any physical manifestations are present. Such a new approach to healthcare will be very disruptive for clinicians who have been trained to suspect the presence of disease on the basis of a patient history and a physical exam. This new perspective on disease diagnosis sets the stage for the emergence of “integrated diagnostic centers” (IDCs) staffed by pathologists, lab medicine specialists, and radiologists. A patient would be referred to an IDC by a primary care physician, at which time the physicians in the diagnostic center would assume total responsibility for diagnosing the patient’s disease, assessing the prognosis of the disease, and making some therapeutic recommendations. This IDC concept is well known in Brazil where it has already been executed on a large-scale basis.

In order for this IDC concept to gain wider acceptance in the future, a number of changes need to be adopted within the specialties of pathology, laboratory medicine, and radiology. First of all, the distinctions between morphologic observations of diseased tissue and clinical lab analyses need to be blended to provide integrated conclusions about the overall pathophysiology of a disease. Following this, the specialties of lab medicine and pathology need to merge to form the new and integrated specialty of diagnostic medicine. Finally, a means need to be discovered to enable the reallocation of funds from the current “therapeutic silos” to “diagnostic silos.” This reallocation of healthcare dollars can be achieved by an increased focus on measuring the efficacy of current drug treatment using diagnostic methods. Given that a substantial percentage of drug therapy, particularly in the field oncology, has been shown to have little effect, the executives of health insurance companies and governmental health programs will gladly reallocate funds to diagnostics if the result is a net savings of the cost of drugs and the avoidance of unnecessary side effects by those patients receiving the unnecessary drugs.

Moving Resources from the Therapeutic to the Diagnostic Silo

I moderated a panel discussion at the recently completed Pathology Futurescape conference sponsored by the CAP Foundation. The panel members spoke to the topic of Corporate Innovation as an Engine for Change and included the following corporate representatives: Gene Cartwright (GE), David Okrongly (Siemens), Dirk Soenksen (Aperio), and Mark Newburger (Apollo PACS). During the course of the discussion about the future of integrated diagnostics, Gene Cartwright suggested that we need to move resources from the therapeutic to the diagnostic silo in order to achieve the promise of pre-symptomatic/pre-clinical diagnoses for patients. This basic idea is incorporated in the concept of the early health model being championed by both GE and Siemens and about which I have posted a number of previous notes. There was insufficient time during the panel discussion to discuss any of the practical details about how to achieve such a reallocation of resources and about which I would now like to speculate.

I have come to the conclusion that the key to increasing available resources for diagnostics in the U.S. healthcare delivery system is embedded in the concept of therapeutic efficacy. By this I mean that we need to begin to organize a broad diagnostic effort to determine whether the various drugs being prescribed and administered to patients, particularly expensive chemotherapeutic agents, are achieving their intended results. Put another way, is the chemotherapy being administered to patients inhibiting the course of the disease or curing the patient? Therapeutic efficacy can be measured by means of biomarker monitoring and  medical imaging.

The necessary first step in this process will be to determine criteria for measuring therapeutic efficacy by drug by disease and recommending the diagnostic tests and procedures used to measure efficacy. After these criteria have been developed, the program can proceed. A number of possible drug treatments will never be initiated because of negative results obtained from companion diagnostics. Other drugs will be discontinued at some point during therapy because of lack of measurable efficacy.  A portion of the dollar savings achieved by the termination of drugs can be reallocated to offset the increased cost of the diagnostics used to assess drug efficacy on a much broader basis.

Needless to say, broader scrutiny of the therapeutic efficacy of drug therapy and terminating proven ineffective therapy will not be greeted with enthusiasm by the pharmaceutical companies despite the fact that the technology exists to mount such programs and the idea aligns closely with a fundamental principle of medicine -- Primum, non nocerum (First, do no harm). Fortunately, neither GE or Siemens, as compared to Roche, has any stake in drug manufacturing. Perhaps they may be willing to throw their weight behind these efforts.

GE Healthcare, UPMC Form Lab Company

Waukesha, Wis.-based GE Healthcare and the University of Pittsburgh Medical Center have formed a new company designed to offer systems to improve the efficiency of laboratory result diagnosis and interpretation.
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GE Medical Partners with UPMC in Pathology Imaging Venture

GE Medical and the University of Pittsburgh Medical Center (UPMC) are launching a pathology imaging business (see: GE, Pittsburgh hospital establish imaging business). Below is an excerpt from the article:

General Electric Co....is investing $20 million in technology that will allow doctors to share and transmit images of microscopic human tissue....GE Healthcare and the University of Pittsburgh Medical Center are each putting up $20 million to establish Omnyx LLC, a business to develop and commercialize technology allowing doctors to store and display on computers, digital images of human tissue from microscope slides, allowing colleagues anywhere to participate in consultations. Jeffrey Romoff, president and chief executive of the University of Pittsburgh Medical Center said the deal "puts together the people — GE — that know the technology and the market with us, who know the science and the patient care."... "Pathology imaging is a natural extension that GE would likely want to get into," said Gene Cartwright, chief executive of Omnyx. ...Omnyx promises to come up with a product in about two years that will speed up scanning materials from a slide into a digital file from between two and five minutes now to about half a minute, he said.

I have published a number of previous notes about the entrepreneurship of UPMC. Dr. Mike Becich and his colleagues have also established the pathology department at UPMC as a national leader in not only pathology imaging but all of pathology informatics. From my perspective, the deployment of practical whole slide imaging systems is a key to the future success of surgical pathology.

Vendor Notebook - Aspyra to upgrade LIS for Physicians Laboratory Services

Aspyra, Inc. has entered into an agreement with Physicians Laboratory Services, Inc. to upgrade the laboratory's LIS to the most current release of Aspyra's CyberLAB Laboratory Information Systems. Read about this and other business news, contracts and new products in this week's Vendor Notebook.
Read more [Healthcare IT News]

Hospitals allowed to pay for EMR interfaces and not violate Stark

As noted in HIS-Talk and HANYS News, CMS released an advisory opinion that allows for hospitals to pay the cost of EMR interfaces without violating the “Stark Law.” Hospitals are restricted under the US law regarding compensation arrangements between physicians and hospitals. HANYS News wrote:

Specifically, a hospital system can pay for the creation of an electronic interface between unique electronic health record (EHR) systems of individual physician practices and the hospital network’s EHR system. The interface would allow physicians, from their practices, to order and communicate the results of tests and procedures performed.

The CMS news was delivered in “Advisory Opinion No. CMS-AO-2008-01″. There are many words used in the advisory; here is a quote that is the meat of the opinion:

The Requestor … owns and operates … hospitals … [and] contracted with a third-party … Vendor .. to install a proprietary health care software information …System …, customized to the Requestor’s specific requirements, including a software interface engine that facilitates access by the custom Physician Practice Interface(s).

Pursuant to the contract between the Requestor and the Vendor, the Vendor provided software licenses to the Requestor that permit the Requestor and its controlled affiliates to use the System.

Currently, the medical staffs of Requestor’s … hospitals have the option to view laboratory reports for the Requestor’s patients over a protected internet connection to the System. The Proposed Arrangement would permit also the ordering or communicating of laboratory tests or procedures performed by the Requestor using the Physician Practice Interface(s).

Numerous physicians on the Requestor’s medical staffs have begun to purchase and use electronic health records (“EHR”) systems for their private practices. Requestor would like to integrate its System with individual information systems maintained by the Affiliated Physician Practices to promote the secure transfer of patient data between the parties. Integrating the System with each Affiliated Physician Practice requires the custom development of an interface that can extract data from the System and transfer it to the Affiliated Physician Practices’ EHR systems. The Requestor may need to develop several versions of the Physician Practice Interface to accommodate the various EHR systems. The Requestor would limit the functionality of the Physician Practice Interface to the ordering or communicating the results of laboratory tests or procedures furnished by the Requestor.

Under the Proposed Arrangement, the Vendor would develop, and the Requestor would pay the development cost of, a Physician Practice Interface customized to the Affiliated Physician Practice’s existing EHR software. … Physician Practice Interface would be used only to order or communicate the results of tests and procedures furnished by the Requestor and could not be used for any purpose other than the ordering or communicating of the results of tests or procedures furnished by the Requestor.

…

Therefore, we have determined that the Proposed Arrangement does not meet the definition of “compensation arrangement” for purposes of the statute’s prohibition on physician self-referral
…

Consideration of a Broader Definition for "Campanion Diagnostics"

I have posted a number of previous notes defining and discussing companion diagnostics. Here are three examples of such notes: A Closer Look at Companion Diagnostics; More Details About Roche's Companion Diagnostics Strategy; Revisiting Roche's Diagnostics Strategy. To quote from the first of them, the term can be defined in the following way:

Briefly stated, [companion diagnostics] is a strategy pursued by some IVD companies, Roche Diagnostics in particular, whereby the company develops a gatekeeper biomarker assay. This is a lab test that serves to qualify a patient for treatment with a particular drug. The most common example of such a test is the HER-2/neu assay that is required prior to treatment with Herceptin.

It occurred to me that we have probably been defining companion diagnostics too narrowly by limiting its use primarily to the measurement of serum biomarkers. I personally have begun to routinely assume that diagnostics, unless otherwise qualified, should be more broadly defined to include both the analysis of serum and tissue biomarkers as well as medical imaging procedures. I have posted a number of notes about molecular imaging, which is defined in the following way in the Wikipedia:

[Molecular imaging] differs from traditional imaging in that probes known as biomarkers are used to help image various targets or pathways, particularly. Biomarkers interact chemically with their surroundings and in turn alter the image according to the molecular changes occurring within the area of interest. This is markedly different from previous methods of imaging which primarily imaged differences in qualities such as densities or water content.

Accordingly and quite simply, I think that we now need to broaden our definition of companion diagnostics to include both the measurement of serum/tissue biomarkers as well as medical imaging and particularly molecular imaging. Such an approach also echoes my belief, expressed in a number of previous notes, that pathology, lab medicine, and radiology are becoming much more closely aligned and should now merge into a new discipline of diagnostic medicine. This broader definition for companion diagnostics also suggests that Roche, GE, and Siemens are embarking on very similar strategy in the pursuit of personalized medicine.

Study Looks at Nanomaterials Transfer in Simple Model of Food Chain

Investigators at the National Institute of Standards and Technology decided to take a look at whether two types of quantum dots (carboxylated and biotinylated ones) can be transferred up a food chain, and whether they tend to biomagnify as they go toward the top of the pyramid. The answer on question of transfer is yes. Regarding biomagnification, the answer seems to be no. In their study, the NIST team investigated the dietary accumulation, elimination and toxicity of two types of fluorescent quantum dots using a simple, laboratory-based food chain with two microscopic aquatic organisms—Tetrahymena pyriformis, a single-celled ciliate protozoan, and the rotifer Brachionus calyciflorus that preys on it. The process of a material crossing different levels of a food chain from prey to predator is called “trophic transfer.” Quantum dots are nanoparticles engineered to fluoresce strongly at specific wavelengths. They are being studied for a variety of uses including easily detectable tags for medical diagnostics and therapies. Their fluorescence was used to detect the presence of quantum dots in the two microorganisms. The researchers found that both types of quantum dots were taken in readily by T. pyriformis and that they maintained their fluorescence even after the quantum dot-containing ciliates were ingested by the higher trophic level rotifers. This observation helped establish that the quantum dots were transferred across the food chain as intact nanoparticles and that dietary intake is one way that transfer can occur. The researchers noted that, “Some care should be taken, however, when extrapolating our laboratory-derived results to the natural environment.” “Our findings showed that although trophic transfer of quantum dots did take place in this simple food chain, they did not accumulate in the higher of the two organisms,” says lead author David Holbrook. “While this suggests that quantum dots may not pose a significant risk of accumulating in aquatic invertebrate food chains in nature, additional research beyond simple laboratory experiments and a more exact means of quantifying transferred nanoparticles in environmental systems are needed to be certain.” Abstract: Trophic transfer of nanoparticles in a simplified invertebrate food web Nature Nanotechnology doi:10.1038/nnano.2008.110 Full story: Research Measures Movement of Nanomaterials in Simple Model Food Chain...... Michael
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Impella 2.5 Heart Pump Given Green Light in US

Abiomed's Impella 2.5 Percutaneous Circulatory Support System, the world's smallest left ventricle heart pump, has been approved by the FDA for use in patients for periods up to six hours. The device is designed to augment cardiac output in patients with acute left ventricular failure by up to 2.5 liters per minute. Medgadget has been following this device since 2004, and we are very excited for this great news, as there is no doubt this device can save many lives by providing extra support just in time when it matters most, usually during ongoing acute MI. This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States. "FDA clearance of the Abiomed Impella 2.5 represents the next step in enabling heart recovery for patients in the U.S. and will likely change the standard of care in the catheterization lab," said Michael R. Minogue, Chairman, Chief Executive Officer and President of Abiomed. "The device seamlessly provides immediate, minimally invasive circulatory support for critical patients." The Impella 2.5 is inserted percutaneously in the catheterization laboratory (cath lab) via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 is cleared for use under the 510(k) for partial circulatory support for periods up to six hours. The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 110,000 are used each year in the United States. Abiomed is currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP. The Impella 2.5 is now approved in more than 40 countries, including in Europe for up to seven days of support under the CE Mark. The Impella platform has been used to treat over 1,500 patients outside the U.S. and has been the subject of more than 40 peer reviewed publications. Press release: Abiomed Receives 510(k) Clearance from FDA for Impella 2.5 Device Animation from Biomed showing the functionality of the device... Product page: Impella 2.5 Flashbacks: Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV; Impella Recover Devices Approved in Germany for Reimbursement... Michael
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INVOcell Fertility Device Approved in Europe

BioXcell out of Beverly, MA has received approval in the EU to market its fertility assist device called INVOcell. The device, an incubator designed to hold a postfertilization oocyte(s), is placed into the maternal vaginal cavity. The idea is to replace the artificial in vitro fertilization (IVF) lab with a natural maternal environment to optimize early embryo development inside the INVOcell device. From the press release: According to Claude Ranoux, M.D., President and Chief Scientist of BioXcell, "INVOcell allows conception and embryo development to take place inside the woman's body, making having a baby simpler and less expensive, while promoting more involvement by the woman. Our device, the INVOcell, and the INVO procedure, are less expensive and simpler to perform than conventional in vitro fertilization." Dr. Ranoux added, "The INVO procedure uses a lower stimulation approach to produce eggs for fertilization. Eggs are combined with sperm in the INVOcell device and placed in the woman's vaginal cavity where it remains for 3 days. This step eliminates the need for a complex IVF laboratory and allows the woman's body to provide the nurturing environment in which conception and early embryo development take place." Press release: BioXcell's New INVOcell Receives CE Mark "Declaration of Conformity;" Allows Conception and Embryo Development to Take Place Inside the Woman's Body Product page: INVOcell Abstract: INVO: a simple, low cost effective assisted reproductive technology Human Reproduction, doi:10.1093/humrep/den163 Flashbacks: IVF Minus The Test Tube Goes On Trial... Michael
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Alan Wallace lectures at PERCRO lab

The PERCRO – Perceptual Robotics Laboratory, from Scuola Superiore Sant’Anna, Pisa, is presenting a series of lectures by Alan Wallace on June 17th, 18th and 19th, 2008.

Dr. Wallace, a scholar and practitioner of Buddhism since 1970, has taught Buddhist theory and meditation worldwide since 1976. Having devoted fourteen years to training as a Tibetan Buddhist monk, ordained by H. H. the Dalai Lama, he went on to earn an undergraduate degree in physics and the philosophy of science at Amherst College and a doctorate in religious studies at Stanford. With his unique background, Alan Wallace brings deep experience and applied skills to the challenge of integrating traditional Indo-Tibetan Buddhism with the modern world, continually seeking innovative ways to integrate Buddhist contemplative practices with Western science to advance the study of the mind.

The three lectures will deal with the results of the collaboration between psychologists and neuroscientists that took physiological and psychological measurements of people involved in an intensive mediation retreat; the convergences between Buddhism and Physics and the Question of Free Will.

MedAvant Divests its Lab System

MedAvant Healthcare Solutions in Atlanta has sold its laboratory test reporting service to ETSec Inc. for an undisclosed sum.
Read more [Health Data management Online Current News]

Ins and Outs

Cut-free surgery a new frontier for medical device companies... [The Pioneer Press] Coming Soon: Shareholder Votes on Universal Health ... [WSJ] FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream ... [FDA] New Repellents Without DEET Show Promise in Tests on Humans... [NYT] Many paths, few destinations: How stem cells decide what they'll be... [Children's Hospital Boston] Looking into Live Cells at Nanoscale Resolution: The highest-resolution 3-D light microscope ever made will change how biologists understand cells.... [MIT Tech Review] NCI Scientists Visualize Gene Regulation in Living Cells... [NIH] The Fingerprints of Embryos: Using DNA fingerprinting, researchers strive to improve in vitro fertilization.... [MIT Tech Review] Researchers Find that Mysterious Protein Protects Against Sepsis... [Howard Hughes Medical Institute] Scientists Produce The First Smell Map... [Weizmann Institute] Research Reveals Molecular Fingerprint of Cocaine Addiction... [Wake Forest University School of Medicine] Important Plant Enzymes Identified... [Brookhaven National Laboratory] New Finding Re-opens the Book on Colon Cancer Stem Cells... [Howard Hughes Medical Institute] Researchers Reveal the Neuronal Computations Governing Strategic Social Interactions in the Human Brain... [Caltech] New potential to curb a neurodegenerative disease: Researchers pinpoint viable cellular targets for therapies to slow the progression of amyotrophic lateral sclerosis... [RIKEN Research] Skip the pretzels: starving may fend off jet lag... [Reuters] AMA says we all need a blood pressure monitor... [ZDNet Healthcare] The "Trust Me" Drug That Makes You Take Social Risks... [io9]... Michael
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Sepsis Microfilter Being Developed

Researchers from Children's Hospital Boston, Harvard Medical School, Boston University, and the Charles Stark Draper Laboratory have been working on a prototype device that can act as a physical filter to remove pathogens responsible for sepsis, reports MIT Technology Review. The device itself contains a pair of microscopic channels--one for blood, the other for a saline-based solution. The two channels meet in a central compartment. The idea is to give the saline solution properties that will selectively draw pathogens out of blood as the two fluids mix. However, because of their very small scale, microfluidic devices have no moving parts that can mechanically mix fluids together. Even as they come in contact, fluids will remain discrete, retaining their respective molecules. Then Ingber [Donald Ingber, principal project investigator at Children's Hospital Boston --ed.] hit upon the idea to use a small magnetic field. He first identified specific molecules that naturally bind to certain pathogens related to sepsis. Ingber and his colleagues then coated these molecules with tiny magnetic beads in solution. They then pumped the solution through one channel as infected blood was pumped through the other. As the two channels funneled into one compartment, the team turned on a small magnet on the side of the magnetic bead solution. As the fluids came in contact, the pathogens from the blood bound with the magnetically coated molecules, which in turn were pulled toward the magnet, away from the blood flow. More from MIT Technology Review...... Michael
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The Meaning of Patient-Centric in Relationship to the LIS

When participating in a recent discussion group that was attempting to define the LIS of the future, the term patient-centric was raised.  I began to wonder whether the notion of patient-centricity has any relevance for the design of an LIS. Understanding that the term has become somewhat of a cliche recently, I decided to develop this note in order to begin to explore the relevance of of the concept for the LIS.

First of all, I suspect that most lab professionals will probably view physicians as the primary "customers" of the clinical labs. If they consider patients as customers at all, it's probably in a tangential manner with the physicians as the critical intermediaries. For the record and in order to pursue this discussion of the patient-centric LIS, I think that both physicians and patients should be viewed as customers of the clinical labs and therefore of the LIS.

Having gotten this point out of the way, I think that there are three important criteria for a patient-centric LIS:

• Patients should have ready access to their test results that are archived in the LIS, understanding that some test results such as reports of malignant disease need to be first presented to a patient by their personal physician in order to place them in the proper medical context.
• Lab test results need to be portable, which is to say that they can be electronically replicated to systems or media controlled by the patient such as personal health records. Such portability is critical if and when patients seek a second opinion about a diagnosis or wants to change healthcare providers.
• Lastly, the patient should be able to acquire some knowledge about the significance of various test results. Such knowledge can be provided by the laboratory generating the results or the patient can be guided to reliable sources of lab information on the web.

Regarding the portability of lab results, I personally believe that all labs should have the capability of generating PDF files of test results for patient use. I have made this point in previous notes (see: What Patients Really Want: An Introduction to the e-Patient). Below is an excerpt from this latter note:

Every lab report transmitted to physicians should be available in PDF format. With the approval and support of clinicians and their staff members, these PDF reports should then be made available to patients, often as attachments to office emails, as soon as they are distributed. Abnormal results for individual patients can be explained by supplementary notes and links can also be provided to high-quality web sites that discuss lab tests and provide reference ranges.

The three criteria listed above that help to define a patient-centric LIS seem eminently reasonable to me and will also serve to make pathology and the clinical laboratories more visible and accessible to patients and healthcare consumers.

Nanotechnology-Based Biosensor from NASA for Early Detection of Biohazards

This NASA developed nanotechnology-based biosensor, designed to detect trace amounts of specific bacteria, viruses and parasites, has now been tested and licensed for commercialization by biosensor technology company Early Warning Inc., from Troy, N.Y. From a NASA statement: This biosensor will be used to help prevent the spread of potentially deadly biohazards in water, food and other contaminated sources. NASA's Ames Research Center at Moffett Field in California licensed the biosensor technology to Early Warning Inc., Troy, N.Y. Under a Reimbursable Space Act Agreement, NASA and Early Warning jointly will develop biosensor enhancements. Initially, the biosensor will be configured to detect the presence of common and rare strains of microorganisms associated with water-borne illnesses and fatalities. "The biosensor makes use of ultra-sensitive carbon nanotubes which can detect biohazards at very low levels," explained Meyya Meyyappan, chief scientist for exploration technology and former director of the Center for Nanotechnology at Ames. "When biohazards are present, the biosensor generates an electrical signal, which is used to determine the presence and concentration levels of specific micro-organisms in the sample. Because of their tiny size, millions of nanotubes can fit on a single biosensor chip." Early Warning company officials say food and beverage companies, water agencies, industrial plants, hospitals and airlines could use the biosensor to prevent outbreaks of illnesses caused by pathogens - without needing a laboratory or technicians. "Biohazard outbreaks from pathogens and infectious diseases occur every day in the U.S. and throughout the world," said Neil Gordon, president of Early Warning. "The key to preventing major outbreaks is frequent and comprehensive testing for each suspected pathogen, as most occurrences of pathogens are not detected until after people get sick or die. Biohazards can enter the water supply and food chain from a number of sources which are very difficult to uncover." Early Warning expects to launch its water-testing products in late 2008. NASA press release: NASA Nanotechnology-Based Biosensor Helps Detect Biohazards...... Michael
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Researchers Determine Structure of Protein in an "Environmentally Friendly" Bacterium

Investigators at Argonne National Laboratory have determined the structure of a key protein domain in a bacterium Geobacter sulfurreducens, an organism known for its ability to fix some heavy metals. The research might have future implications for such things as developing methods to decontaminate polluted or radioactive land sites, or possibly, diagnostics. The researchers, led by Argonne senior biophysicist Marianne Schiffer, characterized the structure of one of the principal domains in a protein responsible for certain types of movement exhibited by the bacterium Geobacter sulfurreducens. Geobacter lives in predominantly low oxygen environments and generates energy by transferring electrons to various metallic electron-accepting atoms such as iron or uranium. This ability suggests that Geobacter might be used for remediation of certain types of hazardous waste. For example, when uranium is reduced by this process to its insoluble form, it no longer leaks into groundwater and engineers can inexpensively remove the precipitated uranium. To get to regions of high nutrient concentration (or to escape from harmful substances), certain types of bacteria use a mechanism called chemotaxis. For chemotaxis to work reliably, the cell must be able to convert external chemical information into internal chemical processes - this process is known as signal transduction. "One of the big questions in biology is how signals get from outside the cell to inside the cell," Schiffer said. The researchers determined the three-dimensional structure of a sensory domain of a membrane-spanning protein which they believe is involved in signal transduction. Schiffer and her colleagues were particularly interested in this domain because it contains heme, a molecular component that is common in oxygen transport proteins, such as hemoglobin, or in other proteins involved in respiration or photosynthesis. While other sensor proteins that contain heme have also been described, this is the first example of a sensor protein that contains a heme covalently bound to the protein, Schiffer said. Press release: Scientists characterize protein structure of environmentally friendly bacteria ... Image caption: Three dimensional structure of the sensory domain of the bacterium Geobacter sulfurreducens showing two identical protein domains interacting with each other as observed in the crystal structure. The two protein domains are represented as ribbons (light blue and purple) and the heme in each protein domain is shown as “stick” model (green and gray). (Source credit: ANL)... Michael
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iSOFT Achieves Key LORENZO Milestone at St Jansdal Hospital

iSOFT has installed LORENZO at the St Jansdal Hospital in The Netherlands as part of a regional Electronic Health Record (Elektronisch Patiëntendossier (EPD)) project. LORENZO EPD viewer allows GPs operating in the community to view patient records as well as laboratory, radiology and pathology reports at the hospital at Harderwijk.
Read more [eHealth News EU]

CAP Foundation's Futurescape Coming Up Soon

The CAP Foundation launched a conference called Futurescape of Pathology last June (see: CAP Foundation Futurescape Lectures Now Available). It served to fill a critical niche in the world of PLM (pathology and lab medicine) continuing education -- a forward-looking view about how these disciplines will evolve in the future. The various lectures stimulated me to post a number of notes including the following: The Future of Medicine and, Therefore, of Pathology and Lab Medicine. I also posted a critique of the conference written by a pathology resident who attended on the basis of a travel award; see: CAP Futurescape Conference: A Pathology Resident's Perspective.

The second conference in this series, entitled Transforming Pathology will be held on June 6-8, 2008, at the Westin O’Hare Hotel near the Chicago ariport. The speaker and topic lineup is once again excellent. The entire program can be viewed here. On-line registration is available. You can also register by fax (847-832-8324) or mail: Futurescape Conference, 325 Waukegan Road, Northfield, IL 60093. The conference is being held over the weekend to accommodate to the schedule of the busy pathologist. It's definitely worth attending.

Using Lasers for Aligning Bio Molecules

Argonne Laboratory researchers have developed a method to align molecules using lasers, which may eliminate the need to crystallize large groups of molecules for synchrotron X-ray diffraction. Crystallization allows scientists to create a periodic structure that will strongly diffract in specific directions when bombarded with X-rays. From the resulting diffraction pattern, scientists can construct a real-space image of the crystal. However, without crystallization, when X-rays collide with multiple, randomly oriented molecules, they diffract in different directions, making it impossible to create a composite diffraction image, said Argonne Physicist Robin Santra. Some molecules, such as many involved with drug interaction, cannot be crystallized, and imaging would require numerous samples to bombard in order to get a full composite picture. Young's laser technique allows for millions of molecules suspended in a gaseous state to be aligned so that, when bombarded with X-rays, they all diffract in the same way. The resulting images are at atomic level resolution and do not require crystallization. "Understanding the structure of the approximately 1 million human proteins that cannot be crystallized is perhaps the most important challenge facing structural biology," Young said. "A method for structure determination at atomic resolution without the need to crystallize would be revolutionary." Young and her team have successfully aligned molecules using a laser, probed the aligned ensemble with X-rays and shown theoretically that the technique could be used for X-ray imaging - see E. R. Peterson et al., Applied Physics Letters 92, 094106 (2008) - but they require a proposed upgrade to the Advanced Photon Source facility located at Argonne before X-ray diffraction can be done experimentally. Press release: Argonne scientists use lasers to align molecules ...... Michael
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Tumor Targeting, Immune System Evading Nanoworms

Scientists from UC San Diego, UC Santa Barbara, and MIT developed metal nanoparticles, that can, because of their shape and polymer coating, evade the body's immune system, allowing for free movement around the body. Additionally, a coating of a special peptide F3 molecule allows the nanoparticle to hone in on tumor cells. Perhaps this is the complimentary technology that is required to make the Kanzius Machine effective against tumors? The scientists constructed their nanoworms from spherical iron oxide nanoparticles that join together, like segments of an earthworm, to produce tiny gummy worm-like structures about 30 nanometers long—or about 3 million times smaller than an earthworm. Their iron-oxide composition allows the nanoworms to show up brightly in diagnostic devices, specifically the MRI, or magnetic resonance imaging, machines that are used to find tumors. “The iron oxide used in the nanoworms has a property of superparamagnetism, which makes them show up very brightly in MRI,” said Sailor [Michael Sailor, a professor of chemistry and biochemistry at UC San Diego who headed the research team --ed.]. “The magnetism of the individual iron oxide segments, typically eight per nanoworm, combine to provide a much larger signal than can be observed if the segments are separated. This translates to a better ability to see smaller tumors, hopefully enabling physicians to make their diagnosis of cancer at earlier stages of development.” In addition to the polymer coating, which is derived from the biopolymer dextran, the scientists coated their nanoworms with a tumor-specific targeting molecule, a peptide called F3, developed in the laboratory of Erkki Ruoslahti, a cell biologist and professor at the Burnham Institute for Medical Research at UC Santa Barbara. This peptide allows the nanoworms to target and home in on tumors. “Because of its elongated shape, the nanoworm can carry many F3 molecules that can simultaneously bind to the tumor surface,” said Sailor. “And this cooperative effect significantly improves the ability of the nanoworm to attach to a tumor.” The scientists were able to verify in their experiments that their nanoworms homed in on tumor sites by injecting them into the bloodstream of mice with tumors and following the aggregation of the nanoworms on the tumors. They found that the nanoworms, unlike the spherical nanoparticles of similar size that were shuttled out of the blood by the immune system, remained in the bloodstream for hours. “This is an important property because the longer these... Michael
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Integration of Anatomic and Clinical Pathology

Although I have posted a number of previous notes about the potential merger of pathology and lab medicine with radiology, I strongly believe that such a change must be preceded by a much tighter integration of clinical pathology (CP) and anatomic pathology (AP). Part of the value of the proposed merger for radiologists will be the ready availability of a total view of disease based on both molecular diagnostics and morphologic observations coming from the pathologists.

As I have noted before, one of the key practice models for this future direction for CP and AP will be the practice of hematopathology in which both the morphologic characteristics of malignant cells as well as their biochemical nature are taken into consideration when arriving at a diagnosis (see: Reinventing Pathology: The Hematopathologist as a Model for the Pathologist of the Future). In addition, hematopatholgists frequently participate in the selection of therapy for patients because such choices are frequently based on their diagnoses and thought processes.

There is growing evidence that the practice of surgical pathology is now moving closer to clinical pathology. Evidence for this can be found in the lectures of Dr. Jeff Myers. He has emphasized the close collaboration of surgical pathologists with pathology informaticians to increase patient safety (see: Aligning Surgical Pathology & Aligning Surgical Pathology & Informatics to Promote Informatics to Promote Patient Safety). Research in tissue biomarkers will also help to convert surgical pathology to a more quantitative discipline (see: In-Vitro Biomarkers vs. In-Situ Biomarkers; Changing Strategies for Interrogating Tissue Samples: A Systems Pathology Primer).

In my past blog notes and in the interest of being all inclusive, I have found myself using the awkward phrase pathology and laboratory medicine to refer to the field. This is truly a mouthful but I can't come up with the better name for the more closely merged CP-AP unit that I am discussing here. Therefore, I have decided to refer to it in the future as PLM. I know that change is merely cosmetic but having a more manageable name will be useful. If and when PLM merges with radiology, this problem will go away. We can then refer to the merged entity as diagnostic medicine.

A Timely Article, But Still a Pain in The...

So I'm in class today instructing the MCG DPT students of the class of 2010 in the care and treatment of patients with low back pain. This morning we reviewed how low back pain is often without a specific diagnosis and of the shortcomings of the medical model (pathology-based) in the care of low back pain for this "non-specific" group. It was almost fitting therefore, when I opened up my Reader during lunch and found this New York Times article about the failings of current treatments for low back pain. "Great!" I said to myself, "I can bring this up... Eric Robertson
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3 Sutter Hospitals Get New Lab Systems

Three hospitals affiliated with Sacramento, Calif.-based Sutter Health will replace legacy laboratory software with various applications from Tucson, Ariz.-based Sunquest Information Systems Inc. The deal is estimated at $1.1 million.
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2007 HASTAC Conference Proceedings Available

An announcement from HASTAC.org ("Haystack")
Humanities, Arts, Science and Technology Advanced Collaboratory

Electronic Techtonics: Thinking at the Interface Conference Proceedings Available Now

Available now for download or for purchase from LULU: "Electronic Techtonics: Thinking at the Interface," the Proceedings of the First International HASTAC Conference, edited by the HASTAC Editorial Collective of Erin Ennis, Zoe Marie Jones, Paolo Mangiafico, Mark Olson, Jennifer Rhee, Mitali Routh, Jonathan E. Tarr, and Brett Walters.

The volume is self-published with Creative Commons licensing, 209 pages long, and includes the entire conference program from last year, URLs for all digital recordings of the conference (available at http://www.hastac.org), and many of the papers from the refereed panels that were chaired and selected by members of the Franklin Humanities Institute's Seminar on "Interface," Duke's contribution to the In|Formation Year.

You can obtain your copy of the Electronic Techtonics proceedings from Lulu's website.

You can download a PDF from there, or order a handsomely designed (by Jason Doty) paperback edition for $12.24 for delivery directly to you. You can order one copy or enough for your entire class. It's great documentation of this moment in the theory, history, and practice of digital media culture.
Read more [Hodges' Model: Welcome to the Quad]

Micro-Gel Drops on a Slide Have Huge Promise

Argonne National Laboratory is reporting that its microarray molecular identification technology (aka "mini-secondary ELISA's"), which features a highly porous polymer matrix for enhanced interaction of molecules with antibodies, has promise in the search for biomarkers for a variety of cancers and other illnesses: The new technology, known as a biochip, consists of a one-centimeter by one centimeter array that comprises anywhere between several dozen and several hundred "dots," or small drops. Each of these drops contains a unique protein, antibody or nucleic acid that will attach to a particular DNA sequence or antigen. A tumor, even in its earliest asymptomatic phases, can slough off proteins that find their way into a patient's circulatory system. These proteins trigger the immune system to kick into gear, producing antibodies that regulate which proteins belong and which do not. "Antibodies are the guardians of what goes on in the body," said Tim Barder, president of Eprogen, Inc., which has licensed Argonne's biochip technology to search for new biomarkers that indicate cancer. "If a cancer cell produces aberrant proteins, then it's very likely that the patient will have an antibody profile that differs from that of a healthy person. You can look for similarities and differences in autoantibody profiles to look for clues and markers that provide early indicators of disease." In their hunt for cancer indicators, Eprogen uses a process called 2-dimesional protein fractionation, which sorts thousands of different proteins from cancer cells by both their electrical charge and their hydrophobicity or "stickiness." The 2-D fractionation process creates 960 separate protein fractions, which are then arranged in a single biochip containing 96-well grids. Eprogen scientists then probe the microarrays with known serum or plasma "auto-antibodies" produced by the immune systems of cancer patients. By using cancer patients' own auto-antibodies as a diagnostic tool, doctors could potentially tailor treatments based on their personal autoantibody profile. "This technology is really designed to take advantage of the information contained within the patient's own biology," Barder said. "What makes this technique unique is that scientists can use the actual expression of the patient's disease as a means of obtaining new and better diagnostic information that doctors could use to understand and fight cancer better. "We're starting to see a way of developing tests and therapies for cancer by bringing the bedside to the laboratory, rather than the other way around," he added. Biochips have already shown promise... Michael
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Peak PlasmaBlade Wants to Be The New Bovie

PEAK Surgical, Inc. from Palo Alto, CA hates the bovie cutter/coagulator. The company cannot stand the 1920's technology behind the bovie, and how its thermal function destroys healthy patient tissue around the cut. What do we hate about the bovie? Well, you know: all those bovie induced burns and destroyed gloves that surgeons are regularly subjected to. Long story short, PEAK Surgical wants its Peak PlasmaBlade, a cold cutter and coagulator, to be the bovie of the 21st century. The company is quite hopeful: a new study presented in a poster session at the ongoing American College of Obstetricians and Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans showed that "PEAK PlasmaBlade™ cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery." More about the technology: Electrosurgery was invented in the beginning of the 20th century and became one of the most-often used surgical tools after William Bovie introduced his electrosurgery (radiofrequency) generator in 1926. Since then, electrosurgical cutting has been performed using continuous radiofrequency waveforms, which thermally vaporizes soft tissue via an electrical arc through air and Joule heating. This results in a cutting and coagulation action that leaves a wide zone of collateral thermal damage. By contrast, PEAK Surgical’s PULSAR Generator supplies pulsed waveforms that produce short plasma-mediated, highly controlled electrical discharges through extensively insulated electrodes on a handheld device -- the PEAK PlasmaBlade. Because the radiofrequency is provided in short pulses with low duty cycle (fraction of time the voltage is ON), and the PEAK PlasmaBlade is so highly insulated, heat diffusion and associated thermal damage to surrounding tissues is limited, resulting in greatly reduced collateral damage and extreme cutting precision. PEAK Surgical’s technology including the pulsed plasma-mediated discharges and electrode insulation techniques were originally developed by Professor Daniel Palanker’s group at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. They have been evaluated in ophthalmic applications, including human studies in retinal and cataract surgery – one of the most delicate, precise and difficult types of surgery, and in preclinical studies. Check out the following product brochure distributed by PEAK Surgical: PeakBrochure - Upload a doc Read this doc on Scribd: PeakBrochure Product page: Peak PlasmaBlade... Press release: PEAK Surgical Announces Positive Results from Preclinical Study of PEAK PlasmaBlade™ for Obstetric and Gynecologic Surgery Video demonstrating the device...... Michael
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HYDROCHALARONE MRI Contrast Agent Does Well in Early Study

HYDROCHALARONE™ nanomaterial is a next generation contrast agent, under development by Roanoke, Virginia based firm Luna Innovations, that has just been successfully demonstrated as an effective MRI image enhancer in the mouse model. HYDROCHALARONE is based on the company's proprietary TRIMETASPHERE® molecular cage construct (second picture below), a molecule formed by up to 80 carbon atoms, that is capable of encapsulating a variety of metals (Scandium, Lutetium, Holmium, Gadolinium) inside its cage. From the press statement by Luna Innovations: The new class of molecules discovered by Luna is called HYDROCHALARONE(TM) ( hi-dro-kal-a-rone )-- Hydro, meaning water, combined with Chalaro, the Greek word for relax. The level of relaxivity is the characteristic of molecules that provides the image enhancement. "The high relaxivity in Hydrochalarone means fewer molecules are needed to obtain a better quality image," said Robert Lenk, President of Luna's nanoWorks division. "Our studies demonstrate that our proprietary nanomaterials do not release gadolinium under conditions which are found in the human body. Our imaging studies in mice have shown Hydrochalarone improves image quality up to 30 minutes after injection at a dose 20 times lower than that used with current agents." "Achieving high magnetic resonance relaxivity with a small, biologically inert, chemical moiety that can be derivatized for targeted tissue delivery, cell tracking, or inclusion as part of a nanoparticle drug delivery vehicle is a Holy Grail within the fast evolving field of biomarker development," said Dr. Joseph Ackerman renowned MRI researcher and Chemistry Department Chairman at Washington University in St. Louis. "The design and production of Hydrochalarones by scientists at Luna nanoWorks may herald such an advance." Luna's HYDROCHALARONE(TM) was selected for preclinical studies and a collaboration with National Cancer Institute's Nanotechnology Characterization Laboratory (NCL). "We hope within 12 months the NCL will provide us a complete preclinical package which will contribute to an Investigational New Drug application," said Lenk. "The end goal of Luna's product development effort with the Hydrochalarone is using it as a fundamental building block that will generate a portfolio of novel imaging agents targeted to reveal diagnostic information specific for a variety of different diseases, such as cancer tumors, sites of inflammation and plaque related to coronary artery diseases, as announced in our previous press release." Product page: Luna's HYDROCHALARONE... Press release: Luna Innovations Successfully Demonstrates MRI Contrast Agent...... Michael
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In the Works: Inhalable Drug Testing Device

Cambridge Consultants is reporting that the company is developing "a low-cost, portable instrument that has the potential to revolutionise [sic] the way certain drug delivery devices are tested." From the press release: Through the innovative use of technology, the new device can mirror the performance and level of data provided by current laboratory laser diffraction measurement machines, for an estimated one-hundredth of the cost when integrated into a high volume device. The device measures the droplet size distribution in an airstream, a technique used in testing respiratory drug delivery devices. Airborne drug delivery for deep-lung treatment relies on generating particles of a very specific size - too large and the drug never reaches the deep lung, too small and the drug is exhaled and is similarly ineffective. Methods for accurately measuring particle size are very much laboratory-based, for instance the Anderson Cascade method, which is laborious and can slow the development of devices, and the c