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.
The controversial 23andMe Personal Genome Test has demonstrated some interesting ancestry numbers, according to a blogger at The Unz Review.
Two more customers are suing California maker of health-related genetic tests 23andMe for making bogus marketing claims. The lawsuits represent continued fallout over the FDA's assertion that the company marketed its products for years without proper regulatory approval.
The FDA backs a market that lets consumers easily gain information about their genomes and genetic risks, an agency official said, despite its move to stop 23andMe from selling its direct-to-consumer health-related genetic tests until they obtain formal regulatory approval.
California's 23andMe has capitulated to the FDA, agreeing to regulators' demands to stop selling all health-related genetic tests while it submits them for a formal regulatory review.
Amid scorn and scrutiny from the FDA, 23andMe is facing a class-action lawsuit claiming the company misled customers in selling genetic tests with no real scientific value, and plaintiffs want at least $5 million in damages.
23andMe has stopped advertising its personal genetic test after a strongly worded rebuke from the FDA, Reuters reports, but the company is still selling its $99 kit despite the agency's demands.
Now that the FDA has fired off a strongly worded rebuke of its Personal Genome Service, 23andMe is standing by the accuracy of its un-approved test, promising to work with regulators but giving no indication that it'll stop selling its sole product.
Direct-to-consumer DNA testing operation 23andMe has never used the words "diagnostic test" to describe its Personal Genome Service, making pains to note that the test lacks FDA clearance and is "not for diagnostic use." Now, rather strongly, the FDA has stepped in to assert otherwise.
Direct-to-consumer DNA testing outfit 23andMe has run afoul of the FDA, and the agency served up a warning letter demanding that the company take its genetic screens off the market until it gets the proper clearance.