FDA Continues Easing DTC, Home Use Test Regulations

In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled loosened regulations in November that will effectively enable growth in the DTC genetic test market, as well as ease restrictions on bringing other CLIA-waived tests to market.

Enabling DTC Tests for Genetic Health Risks
The FDA has slowly been approving DTC tests on a case-by-case basis. But new proposed regulations unveiled in November will allow genetic carrier screening tests, taken by prospective parents, and other genetic health risk (GHR) tests to enter the market without prior review. The new regulatory approach doesn’t apply to genetic tests that inform treatment decisions (e.g., hereditary cancer tests for BRCA1 and BRCA2 genes).

In its November notice, the FDA said GHR test developers will face a one-time FDA review, but can subsequently expand their GHR-marketed tests without further review. The FDA acknowledged in a statement that consumers are increasingly embracing GHR tests to better understand their individual risk for developing diseases and possibly make lifestyle choices to counter these risks. However, the FDA cautioned, these tests can pose “their own risks” if they provide incorrect or misleading information to consumers in the absence of professional medical advice.

“The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation, as these technologies don’t fit squarely into our traditional risk-based approach to device regulation,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “In its consideration of GHR tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight.”

Easing CLIA-Waiver Regulations
On Nov. 29, the agency issued two draft guidances proposing to reduce the burden of applying for CLIA waivers. The first draft guidance is in response to the Cures Act, which requires that FDA allow manufacturers of in vitro diagnostic devices submitting a CLIA waiver to demonstrate accuracy through comparable performance between a waived user and a moderately complex laboratory user, rather than based upon a gold standard. In addition to this statutory change, the draft guidance provides significant detail regarding demonstration of accuracy of a test for purposes of securing the “insignificant risk” waiver.

The second proposal would establish a dual submission pathway enabling test makers to use the same sets of studies to secure 510(k) approval and a CLIA waiver.

Takeaway: The FDA is sending strong signals it plans to continue to streamline regulations enabling easier market entry for innovative products, including DTC tests for GHR and CLIA-waived products.