FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction proposing to allow precertified manufacturers to bring genetic tests to market without undergoing premarket review.

The present policy dates back to the 2013 warning letter the FDA issued to 23andMe ordering the consumer genomics firm to stop marketing its DNA analysis services. Since then, newfangled DTC genetic tests have required premarket approval.

But even before the Trump administration, the FDA has been seeking to modernize its approach to allow room for innovation. According to the agency’s notice for public comment, is not necessary for certain class II (moderate risk) devices, including vitamin D mass spectrometry-based test systems and genetic health risk (GHR) assessment test systems. The catch: GHR test manufacturers will need first time FDA marketing authorization; after that, though, they will be allowed to commercialize new GHR tests without additional review.

Earlier this year, foreshadowed the new policy in its premarket authorization of 10 GHR tests from 23andMe giving the greenlight for DTC launches of other tests without premarket review provided that it followed listed controls, which include the requirement that 23andMe publish:

• Labeling outlining test limitations;
• Information about how the test works and its accuracy vis-à-vis a comparative baseline;
• References to applicable clinical guidelines and disease risks; and
• Information on obtaining a genetic counselor.

The Nov. 6 notice, which at this point is a proposal rather than a formal policy, essentially extends the 23andMe approach to all GHR test makers. There’s also a limitation: The new approach doesn’t apply to diagnostic genetic tests that inform treatment decisions, e.g., hereditary cancer tests analyzing BRCA1 and BRCA2 genes to decide if a woman should have a prophylactic mastectomy.

And for now at least, the FDA is maintaining the hard line on DTC companies issuing warning letters to DNA4Life and Interleukin Genetics for marketing tests without premarket approval.

New FDA Approvals

Meanwhile, here’s a rundown of key new approvals issued by the FDA in late October through November:

NEW FDA APPROVALS

In November, the FDA granted CLIA waivers to the following test kits:

NEW FDA CLIA WAIVERS

New CE Marks & Global Certifications

Notable European CE certifications:

NEW CE CERTIFICATIONS

Other new international approvals included:

• China FDA approval of TBG Biotechnology HLAssure SE SBT portfolio of high-resolution human leukocyte antigen genotyping kits for hematopoietic cell transplantation;
• China FDA approval of Ortho Clinical Diagnostics’ Ortho Vision platform; and
• Singapore Health Sciences Authority approval of Vela Diagnostics’ Sentosa SQ HIV Genotyping Assay.