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News and Press: Industry News

FDA Unveils Guidance On DNA Testing Technology

Thursday, April 12, 2018   (0 Comments)
Posted by: Kate Oesterle
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Law360 (April 12, 2018, 6:07 PM EDT) -- The U.S. Food and Drug Administration on Wednesday rolled out final guidances aimed at driving the development of technology that scans DNA to diagnose genetic diseases, including recommendations for how to develop reliable testing.

The FDA issued two guidances, one of which outlines an approach for test developers to use clinical evidence from FDA-recognized public databases to support clinical claims for their tests. Using these databases will provide test developers with a way to obtain marketing clearance or approval of a new test, the FDA said...


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