FDA Challenges DTC Genomic Tests from Startup Labs

Although the laboratory sector is at loggerheads with the U.S. Food and Drug Administration (FDA) over the regulation of LDTs, that has not prevented the agency from warning two nascent players from marketing genomic tests without the proper approvals.

Last month, the FDA issued letters to Sure Genomics and Solopap International questioning whether the labs were marketing molecular tests without proper clearance from the regulator. On Feb. 16, the agency sent a letter to the Utah-based Sure Genomics, raising concerns about its $2,500 in-home SureDNA sequencing test.

In a statement, Sure said the process for its SureDNA assay “is similar to 23and- Me or AncestryDNA – you sign up, receive a kit, spit in a tube and wait a few weeks. The difference is Sure Genomics promises full DNA analysis from more than 70,000 biomarkers and will update and add upon information every six weeks as new information becomes available.”

Sure did not mention that 23andMe tangled with the FDA back in 2013, when the agency ordered it to stop marketing its direct-to-consumer genome test with interpretative data because it did not have the necessary approval to do so. Direct- to-consumer tests usually require FDA approval. The FDA raised a similar issue with Sure Genomics in its correspondence.

“The SureDNA test appears to meet the definition of a device as that term is defined in section 201 (h) of the Federal Food Drug and Cosmetic Act,” the letter said. “We have conducted a review of our files, and have been unable to identify any FDA clearance number for the Sure DNA test.” The agency asked Sure Genomics to provide a specific number.

The Nevada-based Solopap is selling through its website a $50 home test for pap smears and the presence of the human papilloma virus. Solopap charges an additional $90 to process the assay and issue test results to the consumer.

The FDA contacted Solopap the day after Sure Genomics. Its letter suggests there may be more leeway in the Solopap assay, which appears to be a more traditional assay as opposed to a molecular test. It may be either processed by its lab or by the buyer’s own physician, according to information on the Solopap website. The agency asked Solopap to provide a rationale if it does not believe the tests require FDA approval, and to furnish “a sample laboratory report which provides the test results to the medical practitioners.”

The issue over smaller startup labs such as Sure and Solopap comes as the FDA appears poised to issue final regulations regarding the oversight of laboratory developed tests later this year. Its proposal has created fierce opposition in the laboratory sector, with most recently, the American Association of Clinical Chemistry issuing a position paper in support of maintaining the current CLIA regulations for laboratory developed tests.

Takeaway: The FDA has cracked down on two startup labs and their marketing practices prior to its issuance of final guidelines for the regulation of laboratory-developed tests.