Four months later, 23andMe's clash with the FDA remains unresolved

Anne Wojcicki--Courtesy of 23andMe

In the four months since 23andMe agreed to stop selling all health-related genetic tests in the U.S. while it submits them for a formal FDA review, the California company's future has become cloudier, not clearer. A recent blog post on its web site informed customers that executives continue to meet with regulators, but a resolution to the matter doesn't appear to be anywhere close to happening.

"Despite 23andMe's intense attention on this regulatory process, navigating it will take time," the company explained in a March 31 blog posting. "This means all 23andMe customers who purchased on or after Nov. 22, 2013 [when the FDA issued its order] still do not have access to health results, nor will they in the immediate future."

The company said it is "working with the FDA so that we can return a subset of health reports, but we don't know how long that process might take." What's more, 23andMe said, "we do not have a timeline as to which health reports might be available in the future or when they might be available."

Executives emphasized: "we are doing everything we can to work through this process and return to providing all 23andMe customers access to genetic health information." But the limited status quo reached in December appears firmly in place, and it restricts the company's opportunities for growth and revenue in the months ahead.

On Dec. 5, 23andMe announced that consumers who bought the company's Personal Genomic Service saliva-based tests on or after Nov. 22 could only gain access to ancestry-related genetic information and raw genetic data, minus interpretation, as per the FDA's directive. That directive, it is worth noting again, came in the wake of the FDA's Nov. 22 warning letter that blasted 23andMe for its delay in submitting to the approval process for its PGS tests, a direct-to-consumer DNA test.

At first, 23andMe insisted its tests were for "research and educational purposes only," but the company got caught in the crossfire of the FDA's ongoing bid to assert greater regulatory control over tests that appear to make diagnostic-related health claims.

It's not that resolution isn't in the mix. That's at least the goal. 23andMe asserted in its blog posting that the company's "scientists and executives have met and communicated directly with FDA officials on a number of different occasions over the last few months" with a goal of "getting this right." CEO and co-founder Anne Wojcicki has said that her "main priority is resolution with the FDA," the company's blog posting noted.

But the ongoing delay won't help the company, whose Personal Genome Test recently came under fire from a blogger for producing questionable ancestry results. Some customers are also suing 23andMe for making false marketing claims about what its tests could accomplish regarding both genetic history and gauging future health risks. The lawsuits additionally allege the company sold its test without proper marketing authorization or approval. 

- read the full company blog posting
- here's The Verge's take

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