TAG:

FDA regulations

California Research Team Analyzes Performance of 12 Serological Tests

This is an excerpt of a 2.241-word article in the May 11, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Researchers with the COVID-19 Testing Project used a multidisciplinary effort to analyze and compa…

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Regulators Acted Slowly as Labs Developed Tests for Coronavirus

WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since…

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Digital Pathology Systems Will Create Opportunities

CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administra…

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Low 2013 Molecular Rates May Bankrupt Some Labs

CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As…

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Lab Industry Unprepared For FDA Action on LDTs

CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …

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Marketing Approved Kits Against “Home Brews”

CEO SUMMARY: In past years, it was customary for laboratories to shift away from performing or ordering “home brew” tests in favor of FDA-approved test kits as they became available. However, new marketing models for diagnostic testing are shifting this long-standing practice. HIV res…

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