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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Health Insurers Balk at Paying for Multigene Panels While Clinical Pathology Laboratories and Physicians Pursue Evidence of Clinical Utility

News reports state that Anthem and Cigna have denied payment for some multigene panel tests, saying that the tests are unproven. Other insurers, such as UnitedHealthcare and Priority Health, pay for such tests but only for certain patients

A conflict is building between patients and health insurers over the reluctance among health plans to pay for new, expensive molecular diagnostic assays and genetic tests that clinical laboratory companies offer.

This conflict has caught the attention of the nation’s media. That is probably because it makes a great story, for example, to interview parents who can assert that their sick child suffered because their health insurance plan would not pay for a genetic test the parents believed would make a difference in their child’s clinical care. Of course, pathologists and medical laboratory professionals know that there are a significant number of expensive genetic tests being offered by various lab companies that lack extensive data to support their clinical efficacy. (more…)

Foundation Medicine Striving to Use Next-Generation Gene Sequencing to Enrich Diagnostic Value Offered to Physicians by Clinical Laboratories

Pathologists will want to understand how this innovative company is doing multi-gene analysis of patient tumors that includes information about therapeutics and clinical trials

CAMBRIDGE, MASSACHUSETTS—Next-generation gene sequencing is already changing how cancer is diagnosed and treated for a growing number of patients. Because it moves healthcare closer toward personalized medicine, this development has major implications for anatomic pathology groups and clinical laboratories.

One company in the forefront of personalized medicine is Foundation Medicine, based here in the Boston’s Route 128 biotech corridor. Last week, your Dark Daily Editor, Robert L. Michel, met with the executive team and toured the company’s CLIA-licensed medical laboratory to learn more about this company’s unique approach to clinical diagnostics. (more…)

New Tool for Fighting Antibiotic-Resistant Bacteria: Meet Bacteriophage

Microbiologists and hospital infection control teams are intensifying efforts to identify and control infections of antibiotic-resistant strains of bacteria. Now comes news of a new tool that can provide another way to control such infections.

Timothy Lu, a Harvard Medical School student and Massachusetts Institute of Technology Ph.D. recipient, has found a way to use bacteriophage-viruses that infect bacteria cells but not human ones-to boost the effectiveness of antibiotics. This development could prove instrumental to conquering the problem of antibiotic-resistant drugs, such as methacillin-resistant Staphylococus aureas, which causes 94,000 cases of life-threatening infections among hospital patients each year.

Lu has engineered bacteriophage to cut through biofilm-the slick, protective coating that covers bacteria-and to seek out the gene mutations that create antibiotic resistance. The bacteriophage then destroy the resistance mechanisms, enabling antibiotic drugs to perform better. The combination of engineered bacteriophage and antibiotics have the potential to eliminate nearly 30,000 times more bacteria than antibiotics alone.

Lu received the Lemelson-MIT Student Prize of $30,000 for inventing the bacteriophage platform. He is developing a secondary use of the platform that would allow bacteriophage to kill off deadly biofilms that attach themselves to food processing equipment and medical instruments.

The success of Lu’s invention could spell out a much better prognosis for patients who are discovered to have methacillin-resistant Staphylococus aureas (MRSA) based on confirmation by hospital-based laboratory tests. Laboratories always welcome medical advancements that make a positive result from a laboratory test less devastating/life-threatening to patients. Lu’s new technology may have applications in the treatment of numerous other superbugs and antibiotic-resistant bacteria strains.

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