TAG:

generation sequencing

Response to FDA’s Gottlieb on Reducing Regulatory Burden

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …

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FDA’s Gottlieb Favors Flexibility with LDTs, NGS

CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…

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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 professio…

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A coming transformation: Control over important diagnostic technologies is about to change hands

This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: He…

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November 20, 2017 Intelligence: Late Breaking Lab News

Last Friday, Roche announced an agreement to acquire Viewics, Inc., of Sunnyvale, Calif., in a transaction that, subject to regulatory clearance, is expected to close on Nov. 21. Viewics sells a middleware analytics solution to clinical labs. Terms of the sale were n…

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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…

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Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…

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Clinical Labs Bidding Up Lab Director Salaries

CEO SUMMARY: There’s great news for pathologists and PhDs with expertise in molecular and genetic testing. Salaries are on the rise as more clinical labs build up their molecular and genetic testing programs and need talent to implement and supervise this activity. One experienced medic…

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California Lab Company Offers Genetic Tests with Low Prices

ONE BY ONE, A HANDFUL OF PROGRESSIVE LAB COMPANIES is finding financial success with a strategy of pricing genetic tests at levels that are affordable and attractive to the general public. These labs report an added benefit: They find it easier to get health insurers to pay their genetic test claims….

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UPMC-KingMed Digital Pathology Venture Improves Patient Care

CEO SUMMARY: Many experts think that digital pathology will make it possible to create international pathology subspecialty referral networks. Now in its fifth year, a partnership between UPMC’s Pathology Department and KingMed Diagnostics of China uses telepathology to give Chinese pat…

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