FDA Warns DTC Genomics Firms that Genetic Tests are Not LDTs, May Need Clearance or Approval
June 16, 2010
FDA Warns DTC Genomics Firms that Genetic Tests are Not LDTs, May Need Clearance or Approval
In letters to Illumina, Knome, 23andMe, Navigenics, and Decode, the FDA asserts that DTC genomics firms are marketing medical devices and informs several of these companies that their tests are not laboratory-developed tests that would fall under the purview of CMS.
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