Tag: companion diagnostic

PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions

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What Comes Next for the Pathology Profession?

IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target for government and private payers, along with federal investigators.

The

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Several Big Surprises in 2018’s Top 10 Lab Stories

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laboratories and anatomic pathology groups. What is more notable about these top

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access

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Powerful Forces Are Reshaping Lab, Pathology

THERE IS NO BETTER WAY TO UNDERSTAND HOW THINGS ARE CHANGING within the house of laboratory medicine than to survey current news. Understanding why and how breaking news stories are indicators of deeply-rooted and forceful trends is essential for lab administrators and pathologists who want to keep their labs positioned to offer sophisticated and financially-sustainable

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Anthem Launches Program to Manage Genetic Tests

CEO SUMMARY: Pre-authorization of genetic tests is coming to physicians serving patients insured by Anthem, Inc. Its specialty benefits management company, AIM Specialty Health, will manage the program. AIM will work with InformedDNA, a company that specializes in genetic testing clinical decision support and genetic counseling for health insurers. Anthem has about 40 million members

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July 25, 2016 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This rule would expand APRNs’ authority, currently limited to ordering and interpreting lab tests. In an

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