Regulatory Editor

The U.S. FDA reported it will henceforth treat direct-to-consumer (DTC) tests of genetic risk for disease as class II devices, but FDA commissioner Scott Gottlieb said the agency will open a precertification program for makers of these tests in an effort to streamline the premarket process for individual tests.

The agency has employed a precertification program in the recent past as part of an effort to make regulatory review less cumbersome. The FDA reported in July that it would roll out a digital health action plan that called for precertification of digital health software vendors, a move that was welcomed by industry as a long-overdue overhaul of the agency's regulation of digital health. (See BioWorld MedTech, July 28, 2017.)

Previously, the agency struck a more militant tone in connection with DTC tests of genetic propensity to various diseases. 23andme of Mountain View, Calif., received a warning letter in 2010 about its promotion of such tests, and as recently as 2015, the agency was still working to prevent marketing of DTC tests as demonstrated by the Sept. 21, 2015, warning to Pathway Genomics Inc. of San Diego over its DTC marketing of its Cancer Intercept test. (See BioWorld MedTech, Nov. 11, 2015.)

Gottlieb said DTC tests for genetic health risks (GHRs) are "not without their own risks," citing the consequences of a false negative finding, but he said that the agency must adapt to fast-moving technological iteration, citing the software precertification program as an example. Gottlieb said that should the agency finalize the rule, manufacturers "would have to come to FDA for a one-time review to ensure that they meet the FDA's requirements, after which they may enter the market with new GHR tests without further review." He also pointed to the establishment of special controls for the affected test types via a de novo classification order, which Gottlieb said "outline[s] requirements for assuring the tests' accuracy, reliability and clinical relevance and describe the type of studies and data required to demonstrate performance of certain types of genetic tests."

The move toward DTC tests of this type was evident at least as early as April 2017, when the FDA approved 23andme's Personal Genome Service testing for 10 diseases and conditions. The saliva-based PGS test can detect any of half a million genetic variants to evaluate propensities for Parkinson's disease and late-onset Alzheimer's disease. However, the agency stated explicitly that this is not a diagnostic test system.

The agency's Federal Register announcement regarding the DTC precert program points to the de novo application by 23andme for the company's Personal Genome Service (PGS) test, but Gottlieb cited also the agency's decision to classify the total 25-hydroxyvitamin D mass spectrometry test system into class II with special controls. This was in response to a March 20, 2017, de novo application by AB Sciex LLC of Redwood City, Calif., for a vitamin D assay to be used with the company's Topaz system. The classification was applicable in May 2017, the FDA said.

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