News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Multi-Modality Diagnosis Is New Trend That Integrates Imaging and Lab Testing

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

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 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: )

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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Invivo and In Vitro Integration Unfolding at UCLA Laboratories

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.

Related Information:

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

New Use for Existing Lab Technology Wins UK Technology Award

Here’s another example of taking existing laboratory technology and applying it in a new way. A scientist at Queen’s University Belfast in the United Kingdom is using an existing technology to create what he describes as “intelligent molecules,” capable of identifying tags in human cells that could signal the presence of organisms common in an epidemic. They also could be use to track infections in a population and identify patients who would be vulnerable to certain infections.

This new application of existing technology earned A. Prasanna de Silva, Ph.D., Professor and Chair of Organic Chemistry at Queen’s University, the 2008 Royal Society of Chemistry’s Sensors Award, sponsored by GE Healthcare. The award is given biannually for chemical input into the design of novel sensors or novel applications of existing sensors.

The technology incorporates fluorescent “catch and tell” sensors that emit light signals when they catch chemicals in the blood. It is familiar technology to most laboratories, as it is incorporated into in blood diagnostic cassettes sold worldwide. Hospitals, ambulances, veterinarians, and others use this fluorescent sensor technology to monitor blood for levels of common salt components such as sodium, potassium, and calcium.

The worldwide market for this type of blood diagnostic cassettes totals $50 million. Roche Diagnostics Inc. uses the fluorescent sensor technology in the chemistry module of the OPTI point-of-care blood analyzer, a module that has produced worldwide sales of $39 million.

Using an extension of the same design, de Silva has developed molecules that act as ‘logic gates,’ which are similar to the mechanisms in computers. De Silva and colleagues at Queen’s University are using these molecular logic gates as identification tags for objects the size of biological cells.

The new application could be used in a variety of clinical and other settings, de Silva said. “One such use could be as an ID tag for cells in an epidemic, such as a bird-flu outbreak,” he explained. “From a population, our sensor molecules could help track infection and highlight vulnerable people. Another one is a ‘lab-on-a-molecule’ system which combines several lab tests with a rudimentary diagnosis without human intervention.”

This example demonstrates how advances in science, combined with the ongoing ability to continually shrink the size of diagnostic analyzers, will package long-established and familiar diagnostic technologies in new ways. It is a reminder that, outside today’s clinical laboratory, large numbers of research projects and biotech companies are rapidly developing new assays. It is one reason why laboratory medicine is almost overwhelmed by the daily and weekly stream of press releases and product launches for new biomarkers and new laboratory tests.

Related Information:
New ‘Catch-And-Tell’ Molecules Designed By Queen’s Chemist

New ‘Catch-and-tell’ Molecules Send Out Light Signals When They Catch Chemicals In Blood

Big Policy Shift on EMR and E-Health by American College of Physicians

It’s big news when the nation’s largest medical specialty organization shifts its policy on physician use of electronic medical record (EMR) systems and e-health services. The American College of Physicians (ACP), in Philadelphia, Pennsylvania, issued a new position paper.

ACP says that physicians, patients, technology companies, and policymakers must collaborate to foster e-health activities and electronic communication among physicians and patients. ACP further states that e-health activities-including remote monitoring of patients, personal and electronic health records, and patients seeking health information on-line-have the potential to transform health care in the United States!

“E-health activities have great potential to improve the quality of patient care, reduce medical errors, increase efficiency and access to care, and achieve substantial cost savings,” said ACP President David C. Dale, MD, FACP. “Furthermore, e-health is a critical part of the patient-centered medical home model of care, which in coordination with the other components, is the future of the U.S. health care delivery system.”

The new positions adopted by the ACP are useful for those pathologists and laboratory directors tracking acceptance of new technologies by physicians. Laboratories that establish electronic links with their physician clients end to enjoy a more productive relationship with those physicians.

The ACP’s new position paper is significant for two more reasons. First, it is a statement by ACP that its 125,000 physician-members are ready to embrace and adopt these new technologies. That’s a change from past years, when healthcare lagged other industries in its adoption of information systems and new technology. Second, physicians have been criticized for their collective reticence to adopt electronic medical record systems. The ACP’s position paper specifically calls for physicians and other stakeholders to recognize the potential that information technology holds for transforming healthcare.

“A recent report from the Robert Wood Johnson Foundation estimates electronic medical record (EMR) use in the ambulatory (physician) setting at 24% and in the inpatient (hospital) setting at 61%,” stated the ACP in its position paper. “According to a 2006 ACP member survey, adoption also varies by practice size; smaller practices (five or fewer physicians) have an adoption rate of 18%, while larger groups, (20 or more physicians) have an adoption rate of 58%. Those practices that have implemented EMRs may also include such services as online appointment self-scheduling and secure patient-physician messaging. This interaction between patients and their physicians through the use of electronic tools for health-related purposes has been broadly defined as e-health.”

In addition to citing the potential the IT holds for healthcare, the ACP position paper also acknowledges the barriers to more widespread adoption of information systems in healthcare. For physicians, the challenges of implementing e-health systems can be substantial in part because IT is expensive and the return on investment is not always certain. “For physicians, the financial costs of purchasing systems and incorporating e-health offerings can be considerable,” ACP said.

ACP also recommended investment in demonstration projects to assess how e-health activities can support the relatively new concept of the patient-centered medical home. A patient-centered medical home is an approach to providing comprehensive primary care for patients of all ages and medical conditions. Dark Daily has already alerted its clients and subscribers to the growing support behind the medical home concept (See Dark Daily, August 8, 2008, Doctors Promote “Medical Homes” as Way to Take Us Back to the Future ).

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Patient-Centric E-Health Envisioned by American College of Physicians

Patient-centric e-health services, including personal and electronic health records, remote monitoring of patients, electronic physician-patient communication, and patients seeking health information on-line, represent a new vision of healthcare’s future according to a recent position paper from the American College of Physicians (ACP), in Philadelphia, Pennsylvania. (more…)