Health and Fitness

FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests

Reinforces agency’s commitment to fostering personalized medicine

Silver Spring, Maryland–(ENEWSPF)–July 31, 2014.  Today, the U.S. Food and Drug Administration 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.

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First, the FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or…

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