Genetic Health Risk Tests Getting Quicker FDA Pathway to Market


Makers of genetic health risk tests are getting a more flexible, quicker way to get their products on the market.

The Food and Drug Administration Nov. 6 said it is proposing to exempt genetic health risk (GHR) tests from premarket review under certain conditions. Under this proposal, the FDA would conduct a one-time review of manufacturers’ tests to ensure they meet agency requirements, after which they could send new GHR tests to market without further review, FDA Commissioner Scott Gottlieb said in a statement announcing the policy.

Gottlieb said the agency’s goal “is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers seek.”

GHR tests provide information on an individual’s genetic predisposition to certain diseases or conditions. In April, the FDA approved the first direct-to-consumer GHR tests, 23andMe’s Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions, including Alzheimer’s, Parkinson’s, and blood clots.

The medical device industry wants the FDA to use a similar approach for other diagnostics, Mark E. Brager, vice president of communications at the Advanced Medical Technology Association (AdvaMed) told me.

AdvaMed “has long supported a modernized, risk-based approach to FDA oversight of all diagnostic tests which would foster innovation while ensuring patient access to safe and effective tests,” Brager said.

Read my full article here.

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