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…)

Mayo Clinic and Whole Biome Announce Collaboration to Research the Role of the Human Microbiome in Women’s Diseases Using Unique Medical Laboratory Tests

This joint research effort will initiate a new field of clinical laboratory diagnostic tests that target the human microbiome

Mayo Clinic Center for Individualized Medicine is about to commence clinical trials utilizing innovative clinical laboratory tests that target the human microbiome. Women’s health is the initial focus for these clinical studies.

Mayo Clinic is collaborating with San Francisco-based Whole Biome, Inc., to conduct these clinical trials. Whole Biome developed the diagnostic tests to be used in the clinical study. (more…)

National Institutes of Health Creates Partnership with Big Pharma to Improve Development Success of New Drugs and Diagnostics and Speed FDA Clearance

Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals

Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories.

Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups. The goal is to jumpstart research to find targets for new drugs and diagnostics, noted a Genomeweb.com article. (more…)

Mathematical Modeling of Systems Pharmacogenetics by Researchers at Penn State May Create New Opportunities for Clinical Pathology Laboratories

Goal is to apply differential equations with pharmacogenomics to better predict a patient’s response to prescription drugs, a development that could create role for pathologists to help clinicians interpret the data from such medical lab testing

New approaches to mathematical modeling are poised to transform pharmaceutical drug research and development—and create new opportunities in clinical laboratory testing down the road. U.S. and Chinese scientists have developed statistical models that more accurately simulate a drug’s reaction in a patient.

Using differential equations, these researchers seek to integrate mathematical modeling of drug reactions into pharmacogenomics. Their goal is to better predict interpersonal differences in drug response based on genetic information. This will help clinicians to develop a strategy for personalized drug delivery. (more…)

New Finding Has Major Implications for Genetic Testing as Researchers Learn that Greater Numbers of Humans Have Multiple Personal Genomes

New insights about personal genomes will give pathologists and clinical laboratory scientists different ways to use genetic tests in the screening, diagnosis, and treatment of disease

Here is a human genome curve ball for pathologists and clinical laboratory scientists engaged in genetic testing in their medical laboratories. New research indicates that a larger number of humans than was once believed may have more than one genome. This has implications for many medical and health issues.

Until recently, scientists assumed that, as a rule, each individual had a unique genome. Conditions such as mosaicism and chimerism were considered a rarity.

Greater Incidence of Multiple Genomes in a Single Individual (more…)

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