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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Sysmex Preparing to Move New Molecular Assays to Market

Molecular diagnostics has the same potential to create new winners and new losers among in vitro diagnostics (IVD) manufacturers as it does to clinical labs and pathology groups. New molecular assays with the ability to dramatically improve the detection of disease and guide physicians to identify the most effective therapy for individual patients, can radically change the existing market status quo.

One example of how molecular tests can open new markets for established IVD vendors is the work underway at Sysmex Corporation to gain approval by the U.S. Food & Drug Administration (FDA) for its new instrument system, the RDI-100i, which is designed to help surgeons who treat breast cancer patients. Sysmex says that, “based on the one-step nucleic acid amplification (OSNA) method that Sysmex developed, our system for rapid detection of breast cancer lymph node metastasis (comprising the gene amplification detector RD-100i used in conjunction with the gene amplification reagent lynoamp BC) delivers results with the same level of precision as the conventional procedure in about 30 minutes.” Sysmex hopes the system can deliver a major benefit, stating “intra-operative detection of metastasis to the lymph nodes in surgery for early-stage breast cancer enables excision of the affected lymph node during the same operation, and therefore helps to lighten the burden on patients by lessening the need for resurgery while lowering the risk of recurrence.”

Last week, at the annual meeting of the American Association of Clinical Chemistry (AACC) in Washington, DC, Dark Daily was able to catch up to the Sysmex executive team from Kobe, Japan, and Mundelein, Illinois, to discuss progress of this new Sysmex molecular assay and instrument system. In Japan earlier this spring, Sysmex obtained permission from regulators in that country to introduce and sell the RDI-100i system and the breast cancer test. It is pursuing similar regulatory approvals in Europe and the United States.

There are two intriguing elements to this story. First, Sysmex has targeted cancer as major corporate product development effort. Beside breast cancer, it hopes to develop molecular assays for colon, gastric, lung, cervical, and ovarian cancers. Second, Sysmex believes that its core competencies and technologies can form the foundation of its molecular tests. For example, the Sysmex technologies for passing cells through a gate, while counting, classifying, and evaluating-used in its hematology system-provide a proven technology base upon which to develop molecular assays.

Thus, the message here for lab directors and pathologists is to pay closer attention to the molecular research and development efforts of the major in vitro diagnostics companies. As with Sysmex, each major IVD company has core competencies and technologies in clinical laboratory testing that often can be matched with molecular technologies to produce some very innovative diagnostic assays.

On another subject, at AACC this year, Sysmex Corporation hosted its customer appreciation event at the Mt. Vernon estate of George Washington. George Washington himself was on hand to greet the lab directors, pathologists, as well as the staff from Sysmex. His presence made it a memorable evening, as documented by this photograph of President Washington conversing with Dark Daily Editor Robert Michel and Deborah Michel, R.N. of The Dark Report. Always politically astute, President Washington neither “broke character” nor acknowledged the current presidential election cycle.


Robert Michel

Editor, Dark Daily

Related Items:
Automation of Examinations to Detect Breast Cancer Lymph Node Metastasis: a First in Japan

Combinational Analysis of a Whole Lymph Node by OSNA and Histology for Intra-Operative Detection of Micro-Metastases

Mayo Clinic Considers Implementing Genetic Tests Enable Personalized Medicine

It may be that the hospital industry’s first implementation of genetic testing will be to support improved use of the prescription drug warfarin in anti-clotting therapy. Healthcare companies and hospitals are banking on the fact that genetics can answer questions about which drugs are safe for individuals to use. Medco Health Solutions and the Mayo Clinic are currently collaborating on a study on personalized medicine to confirm whether genetic testing can help eliminate the life-threatening and costly complications that many patients develop after starting a prescription of the anti-clotting drug warfarin.

This is the latest study in the realm of “personalized medicine,” in which physicians use genetic or other molecular tests to tailor a patient’s treatment. Promoters of personalized medicine say the science boils down to delivering the right treatment at the right dose to the right patient at the right time. Doctors use genetic testing to customize the dosage of a drug, determine which treatment will work and which may pose safety problems, and determine a patient’s susceptibility to disease. These customized therapies have already been put to some clinical use and drug makers, biotech companies, medical institutions, testing laboratories, and government agencies such as the Food and Drug Administration and National Institutes of Health all appear eager to advance the practice.

Each of the types of companies listed above have a different incentive to support personalized medicine. Drug makers and biotech companies can increase their profit by developing drugs tailored to people with specific genetic make-ups. Medical institutions can provide better and safer care to their patients. Government agencies can look forward to a reduction in side effects and health-care spending to treat those side effects (A study by the American Enterprise Institute and the Brookings Institute estimates that the use of genetic testing to personalize dosages of warfarin alone could reduce health care spending by $1.1 billion a year).

For clinical laboratories, the widespread use of genetic testing to tailor drugs and drug dosages has long been expected to increase utilization of genetic assays. Should health insurers discover that the inclusion of these tests in treatment protocols can save billions of dollars now spent in treating life-threatening side effects, then it is likely that payers will offer adequate reimbursement for genetic testing that contribute to a reduction in negative side affects. The FDA has already approved personalized medicine drugs from Genentech, Novartis, and Roche Holding.

Ongoing advances in the knowledge of how genetics can affect specific diseases are being combined with new technologies in molecular diagnostics to create assays which have improved levels of sensitivity and specificity. Should healthcare leaders like the Mayo Clinic introduce clinical protocols such as genetic testing linked to warfarin prescriptions, then the day is not far off when most of the nation’s community hospitals will similarly embrace this type of genetic testing for their patient population. Progressive pathologists and laboratory directors should be developing strategies that prepare their laboratories to support this next generation of molecular diagnostics.

Related Articles:

New genetic tests boost impact of drugs

Medco Launches Collaboration To Study Emerging Field of Personalized Medicine (press release)

Personalizing medicine: Researchers study how genes affect proper dosages