Some experts consider MIMS to be the classic LIS on steroids because they are designed to handle the vast amounts of data generated by the latest generation of genetic tests
Steady improvements to next-generation genetic sequencing, lab-on-a-chip technologies, and lab automation are triggering substantial increases in the volume of data generated at medical laboratories and pathology groups. The future of personalized medicine lies just as much in the analysis of the data generated by these tests as it does in how labs perform these procedures.
Laboratory Information Systems (LIS) help to manage and organize much of this data. However, over the past decade, the volume of data generated by molecular and genetic testing has outpaced the organization, reporting, and interfacing features of popular LISs. With more than 3-billion base pairs of DNA in the human genome, each sample analysis has the potential to generate huge amounts of data. (more…)
Today Dark Daily wants to introduce you to the emerging medical discipline of “multi-modality diagnosis.” Advances in genetics and molecular technologies are actively breaking down the traditional scope of practice for several medical specialists. At ground zero in this new area of medicine are pathology and radiology.
Multi-modality diagnosis can be defined in a simple manner. It is the use of several different types of clinical data-in an integrated fashion-to make a diagnosis. “Integration” is the key concept here, since physicians have always assembled information about the patient from several sources as they proceeded to evaluate the patient and make a diagnosis.
As doctors and researchers learn more about genetics and the role of DNA, RNA, and proteomics in various illnesses and ailments, there are huge increases in the volume of data now relevant in assessing the patient’s condition and determining the most accurate diagnosis. At the same time, medical specialties, particularly those of radiology and pathology, that formerly could work somewhat independently to evaluate the patient and provide the referring clinician with a report that was rather straightforward and simple, now face a new challenge. The expanding knowledge base of genetic and molecular information means that their evaluation of the patient needs to incorporate the findings of other medical specialists if the final assessment is to be accurate and useful to the referring clinician.
In other words, genetic medicine is the active catalyst that is already motivating different medical specialties to interact more closely to assess and diagnose certain types of diseases. At the forefront of this trend are progressive radiologists and pathologists-specifically those working with molecular imaging and molecular pathology. For example, in leading academic centers, it is growing ever more common for the neuropathologist and the neuroradiologist to review each other’s images before signing out their respective cases. In some laboratory settings, these two subspecialists are already developing a single, integrated report that goes to the referring physician.
Healthcare informatics is another channel of innovation propelling multi-modality diagnostics forward. Independent of pathology and radiology, there are informaticians pulling together disparate sets of patient data, then running this data through sophisticated software algorithms to develop diagnostic information that gives the patient’s physician new knowledge. Within the field of healthcare informatics, these innovators constantly describe their work as bringing together multiple modalities of data. Dark Daily readers should note that this effort is happening outside of the pathology and radiology specialties. It is an external trend to both professions.
Those interested in learning more about multi-modality diagnosis have two resources. In a recent issue of The Dark Report, a detailed intelligence briefing was published on this topic under the title “Multi-Modality Diagnosis Heading for Lab Medicine.” Dark Daily subscribers who would like a complementary copy of this intelligence briefing should contact Ron Martin at email@example.com.
The second resource for learning more about multi-modality diagnosis is the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics http://www.molecular-summit.com On February 10-11, 2009, national and world leaders in molecular imaging, molecular diagnostics, and integrated informatics will be leading strategic sessions and case studies on this subject. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania.
Speakers from such organizations as Massachusetts General Hospital, Stanford University Medical Center, MD Anderson Medical Center, UCLA Medical Center, Siemens, and the Institute for Systems Biology will provide the latest innovations in the integration of in vivo and in vitro diagnostics. Last year’s Molecular Summit attracted 225 attendees, along with editors and reporters from 15 healthcare publications. This next Molecular Summit has compelling case studies of how molecular diagnostics, when integrated with molecular imaging and other data sets, is giving clinicians powerful new insights for making diagnoses, identifying appropriate therapies, and monitoring patient progress.
The full agenda and speaker line-up for this year’s Molecular Summit can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/agenda.htm )
Make your plans to join us at Molecular Summit 2009 to learn how your laboratory can benefit from multi-modality diagnostics.
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It’s no surprise that topping The Dark Report’s list of Top Ten Most Important Stories of 2008 for the laboratory industry is the successful repeal of the Medicare Part B Laboratory Services Competitive Bidding Demonstration Project. Across the nation, labs feared the consequences were federal health officials to have implemented the flawed scheme that was scheduled to commence in the San Diego-Carlsbad-San Marcos SMA (statistical metropolitan area) by July 1, 2008.
Our list of the Top Ten Most Important Lab Industry Stories of 2008 leads off the latest issue of The Dark Report, published last week and arriving at client’s locations here and abroad. This annual listing is closely-watched because it provides a clear assessment of major trends unfolding in laboratory medicine.
Editor-In-Chief Robert Michel, after explaining why repeal of Medicare Competitive Bidding was the single most important development during 2008, characterized the balance of 2008 as otherwise a quiet and relatively uneventful year. He wrote “No other story on the Top Ten list approaches the magnitude of importance and implications of Medicare competitive bidding repeal. However, that is a good thing because it means that, over the course of 2008, there were few events that represented disruptive or unwelcome change to the majority of laboratories and pathology group practices.”
In fact, Editor Michel picked the huge increase in the volume of Vitamin D testing as the second most important lab industry story for 2008. “This phenomenon is directly related to widespread media stories about: 1) the alarming increase in the number of people with Vitamin D deficiency; and, 2) the negative health consequences for individuals who are deficient in Vitamin D,” noted Michel in The Dark Report. “Attention to Vitamin D deficiency during the past two years shows how speedily a new clinical guideline can become accepted, particularly when it is something that is easy for consumers to understand.”
Top story number ten was described as “2008-Not a Year for Big Lab Deals as Relative Calm Rules Lab Market.” Michel observed that no major or disruptive laboratory acquisitions took place during the year. He noted how this was unusual for a trend that reaches back to the mid-1980s. However, it remains true that Wall Street is keenly interested in molecular diagnostics. That was reflected in the willingness of Roche Holdings (NYSE: RHHBY) to pay the premium price of $3.4 billion last April to acquire then $290 million Ventana Medical Systems. (See Dark Daily, “Roche Purchases Ventana by Offering Higher Price”, February 22, 2007).
Subscribers and readers of Dark Daily are invited to send in their picks for the most important medical laboratory stories for 2008, along with their reasons why the story is significant. We will publish the best of these submissions. E-mail to: firstname.lastname@example.org.
2008’s Top Ten Lab Stories Lacked Disruptive Impact
California is often a national leader for innovations in managed care contracting, as well as new approaches for delivering healthcare. So when your Dark Daily editor visited the laboratory at the UCLA Medical Center this week, he was quite curious about the ways in which clinical laboratory testing and anatomic pathology services are being used at this respected national academic center.
For one thing, UCLA has recently moved into a brand new hospital building. The Ronald Reagan Medical Center is a 525 bed facility (all single patient rooms) and is designed to be state-of-the-art. The UCLA Medical Center is also a world-class institution. It is proudly flying banners throughout the campus which recognize its selection by U.S. News and World Report as the nation’s number 3 best hospital. (Are you interested in which hospitals are ranked 1 and 2? We provide a list of U.S. News & World Report’s Top Ten Best Hospitals at the end of this e-briefing.)
Exciting things are unfolding at the Department of Pathology and Laboratory Medicine. In a briefing session with Scott W. Binder, M.D., Senior Vice Chair, Pathology Clinical Services and Chief, Dermatopathology, your Dark Daily editor learned about a collaborative effort with the Department of Radiology and the Department of Molecular and Medical Pharmacology to develop integrated patient care pathways in several different types of cancers. The particular focus is on lung cancer, melanoma, and breast cancer. The goal is to develop an integrated report which incorporates the radiology components with the pathology report. Molecular assays will be used so that the report emphasizes information about prognostic genes and the most appropriate therapeutic options for the patient. This is an effort to integrate in vivo and in vitro diagnostics to advance patient care.
Over in the clinical laboratory, there were several interesting things that are unique to the UCLA Medical Center. At the 10-story Ronald Reagan Medical Center building, there is a new core laboratory. However, competition for space within the facility meant that the clinical laboratory did not get all the square footage it required to centralize all laboratory testing activities across the campus into one site. Consequently, there are at least four different locations where significant laboratory testing activity takes place.
For example, a medical building next to the new hospital holds a large patient drawing center (serving an average of 500 patients per day). This space also has the accessioning center for routine specimens, along with a fully automated pre-analytical line supplied by Beckman Coulter that includes specimen sorting, de-capping, centerfuging, aliquotting, and re-capping. Prepped specimens are then sent next door to the new core laboratory in the Reagan Medical Center for testing. At the core laboratory, different academic experts supported their “best of breed” choices for analyzers. Thus, the automated line is by Beckman Coulter, while Roche and Olympus supplied chemistry and immunoassay analyzers. PT/PTT testing is done on a system by Siemens (Dade Bering), and hematology is performed on a Sysmex automated line. The clinical laboratory performs tests for inpatients, outpatients, and outreach patients.
Dark Daily summarizes this day of site visits and learning with two observations. First, UCLA’s Department of Pathology and Laboratory Medicine is proactively crossing traditional medical specialty silos to support collaboration with a goal to advancing personalized medicine. For that reason, expect to see some interesting research breakthroughs, particularly in the areas of molecular and genetic testing, from the UCLA pathology department.
Second, the competition for limited resources in healthcare was visible at the new Ronald Reagan Medical Center. Even in a new, state-of-the-art facility, demand for space by all the clinical services was so intense that the clinical laboratory had to settle for a space allotment that made it impossible for them to consolidate all major laboratory testing facilities into a single location.
U.S. Hospitals Honor Roll
Top Ten Hospitals as Ranked by U.S. World & News Report in 2008:
1. Johns Hopkins Hospital, Baltimore
30 points in 15 specialties
2. Mayo Clinic, Rochester, Minn.
28 points in 15 specialties
3. Ronald Reagan UCLA Medical Center, Los Angeles
25 points in 14 specialties
4. Cleveland Clinic
25 points in 13 specialties
5. Massachusetts General Hospital, Boston
24 points in 12 specialties
6. New York-Presbyterian Univ. Hosp. of Columbia and Cornell
22 points in 12 specialties
7. University of California, San Francisco Medical Center
21 points in 11 specialties
8. Brigham and Women’s Hospital, Boston
18 points in 11 specialties
9. Duke University Medical Center, Durham, N.C.
18 points in 11 specialties
10. Hospital of the University of Pennsylvania, Philadelphia
18 points in 10 specialties
For the third time in the past ten years, laboratory industry entrepreneur Brian Carr is heading up a new laboratory company he helped found. Earlier this week, OralDNALabs, Inc. of Brentwood, Tennessee, announced it was open for business. Carr will be its President and Chief Executive Officer.
OralDNALabs has a unique strategy. It plans to offer genetic tests to dentists. It is starting with two proprietary molecular assays. One test, MyPerioPath, uses DNA to identify both the presence and bacterial load of pathogens associated with periodontal disease. The second test, My PerioID PST, uses technology licensed from Interleukin Genetics Inc. (AMEX:ILI) of Waltham, Massachusetts. This test is predictive of the patient’s susceptibility to periodontal disease by analyzing the Interleukin 1 genes. With these first two assays, OralDNALabs says that it will provide dentists with a more precise method for diagnosing and treating gingivitis and periodontitus.
Brian Carr was involved in starting two other laboratory companies. In 1998, he was one of the original founders of Pathology Consultants of America, Inc., (PCA) based in Brentwood, Tennessee, where he served as CEO (see The Dark Report, April 13, 1998). PCA was acquired by AmeriPath, Inc. in December 2000. Then, in April 2004, Carr formed American Esoteric Laboratories, Inc. (AEL), also headquartered in Brentwood, Tennessee (see The Dark Report, April 26, 2004). Carr was Chairman and CEO of AEL up until its acquisition by Sonic Healthcare Ltd in December 2006.
Now, with the launch of his third laboratory company in the past ten years, Carr will attempt to bring molecular diagnostics to the dental profession. As careful readers of Dark Daily will recall, we have written in recent months about research studies that are using saliva specimens to diagnose a variety of diseases, including cancer (see Advances in Salivary Diagnostics Point to New Ways to Detect Cancer and Other Diseases). Experts predict that many of these emerging diagnostic technologies will find ready application in oral health. Newly-formed OralDNALabs may be the first laboratory company organized specifically to serve dentists and other oral health professionals. As they do, they must answer a fundamental question: are dentists ready to order laboratory tests as a regular part of their daily routine?
Dental and Laboratory Veterans Form Specialty Diagnostics Laboratory Focusing on Dental Related Disease