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July 31, 2014
11:29 EDTBRLI, DGX, LHFDA announces steps to ensure reliable diagnostic test results
The FDA announced that it took "important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results." The FDA issued a final guidance on the development, review and approval of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients, the agency said. These tests are commonly used to detect certain types of gene-based cancers. The FDA also is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests, which are designed, manufactured and used within a single laboratory. The agency also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements. Publicly traded laboratory companies include LabCorp (LH), Quest Diagnostics (DGX) and Bio-Reference Labs (BRLI). Reference Link
News For LH;DGX;BRLI From The Last 14 Days
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November 19, 2015
16:27 EDTLHGlenview Capital Management reports 5.29% passive stake in LabCorp
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