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Medical labs to get new FDA oversight
Medical labs to get new FDA oversight

The Food & Drug Administration on Thursday announced it would step up its regulation of a class of lab tests that have been key in ushering in an era of personalized medicine -- a step the agency has long considered against strong opposition by small labs. The FDA's proposal would tighten the agency's oversight of laboratory-developed tests, which are designed, manufactured and used within a single lab. Most of the tests that would now come under more stringent review are used by physicians and hospitals to help diagnose and treat patients, and they have been widely used to detect certain types of gene-based cancers and guide their treatment. As medical practice has grown...

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