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Shuren: LDT Reliability Critical To Precision Medicine Initiative

The head of CDRH said the agency's efforts to oversee laboratory developed tests are critical to ensuring reliability of genetic tests in conjunction with the president's Precision Medicine Initiative.

As the U.S. health care system is poised to further embrace personalized medicine, CDRH Director Jeffrey Shuren says it is critical for FDA to use its authority to regulate lab developed tests (LDT), such as those for genotype testing, to ensure they are reliable.

Speaking before a Senate Health, Education, Labor and Pensions Committee hearing on Precision Medicine, lawmakers appeared shocked when Shuren told...

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