FDA: Tougher companion Dx regs will boost quality, safety

Certain companion diagnostics tests will face increased FDA regulatory scrutiny in an effort to boost overall standards for the market, commissioner Margaret Hamburg said recently. While regulators are still working out the details, Forbes reports that Hamburg sees companion diagnostics as among the tests that will require more FDA oversight. Many had previously been considered lab-developed tests, a class that right now doesn't need FDA premarket review to reach patients. But Hamburg said lab-developed tests, or LDTs, have become more "sophisticated and complex," according to the article, leaving regulators "to make sure that the accuracy and clinical validity of high-risk tests are established before they come to market." Story

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