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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To Help Physicians and Patients, Medical Laboratories with BRCA Breast Cancer Tests Are Posting Mutation Data into ClinVar’s BRCA Database

Innovative use of crowdsourcing allows pathologists and genetic scientists to create a sizeable database of BRCA mutations that is accessible to clinicians and patients

There’s a new development in the longstanding battle over proprietary healthcare data versus public sharing of such information. Pathologists and clinical laboratory managers will be interested to learn that, when it comes to genetic testing of the BRCA mutation involved in breast cancer, a public data base of mutations is growing so rapidly that it may become the world’s largest repository of such information.

It was last year when the Supreme Court ruled in the gene patent case of Association of Molecular Pathology versus Myriad Genetics that human genes were not patentable. Following that decision, some financial analysts stated that Myriad Genetics, Inc. (NASDAQ:MYGN) retained a competitive advantage over other medical laboratories due to its huge database of mutations in the BRCA genes. (See Dark Daily, “Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories,”  July 1, 2013.) (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…)

World’s Largest Food Company Spends $567 Million to Buy into Pathology Laboratory Testing and Pharmaceuticals

Nestlé says its Prometheus Laboratory acquisition will help it develop products for patients with metabolic conditions and to promote brain health

When it comes to the brave new world of genetics in pathology and clinical laboratory testing, such terms as pharmacogenomics, companion diagnostics, and personalized medicine have been coined to describe the intersection of genetic testing and molecular diagnostics with emerging medical practice. Now the world’s largest food company is putting forth a vision of how genetic testing can inform decisions about the patient’s nutrition.

It was last May when the health-science unit of Nestlé SA, (VTX:NESN) the giant foods company in Vevey, Switzerland, announced its purchase of Prometheus Laboratories Inc., of San Diego, California. The price was $567 million.

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New Pathology Testing Device Enables Oncologists to Diagnose Cancer in One Hour at the Bedside with 96% Accuracy

Smartphone-based lab testing device could eliminate need to send biopsies to pathology laboratories

For years, pathologists have wondered when technology would make it feasible to diagnose cancer at the patient’s beside. Eliminating the need for a traditional biopsy that goes off to the anatomic pathology laboratory, and requires 24 hours or more to process the tissue and evaluate the case. Now scientists at Harvard Medical School may be close to perfecting a device that can allow oncologists to do exactly that type of bedside analysis and produce a diagnosis in 60 minutes or less!

The heart of this technology is a new microchip that interacts with smartphone software. Researchers believe it will be possible for physicians to diagnose cancer at the bedside in less than 60 minutes.

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Pioneering Oncology Group Earns Recognition as a Medical Home

Pathologists may be asked to do more consults by oncologists practicing in a medical home

Recently a pioneering oncology practice in Philadelphia was recognized by the National Committee for Quality Assurance (NCQA) as a medical home practice. Though the NCQA medical home program focuses on primary care, a few specialty practices have gained medical home recognition.

This is a milestone on the road to expanded use of the medical home care model. It is also an early warning to pathologists and clinical laboratory managers that other medical specialties may take steps to implement a medical home practice. It is believed that physicians practicing in this care model are likely to be more careful users of medical laboratory tests.

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