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FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

NEW YORK (GenomeWeb) – Late last week, the US Food and Drug Administration lifted some regulatory hurdles for makers of direct-to-consumer genetic health risk tests. After obtaining a first premarket authorization for a genetic health risk (GHR) test, manufacturers can now commercialize new tests without additional review.

Last Friday's decision was largely expected — the FDA said it intended to do so in a notice it made available for public comment in November. In its notice, the FDA wrote that it "has determined that a one-time FDA review of a genetic health risk assessment system is necessary to mitigate the risk of false negatives and false positives by ensuring that certain information be submitted to FDA to allow the agency to assess the safety and effectiveness of the devices as well as to ensure the devices perform to acceptable standards."

In addition, the FDA added that there are four exceptions to the types of tests that could be commercialized under the classification: prenatal testing, cancer predisposition testing, pharmacogenomics testing, and genetic diagnosis of deterministic autosomal dominant variants.