23andMe Complies With FDA Order

23andMe has agreed to halt health-related genomic testing until the Food and Drug Administration (FDA) has given its explicit approval for such assays. The Mountain View, Calif.-based lab is continuing to offer what it calls “ancestry testing” and raw genetic data without providing any specific interpretation. Its Web site explicitly requests visitors to acknowledge the change before they’re allowed to place any orders. The FDA ordered 23andMe last November to stop offering its $99 genomic analysis because it had not responded to questions the agency raised after it submitted its 510(k) form or clinically validated how the assay is being used. The FDA had ruled the test is a Class III medical device and requires prior approval. Although 23andMe Chief Executive Officer Ann Wojcicki had complained on her company’s official blog that the FDA’s concerns were overblown, it complied with its order in early December. Takeaway: 23andMe’s business could be impacted for an indefinite period of time by withdrawing its personal genomic assay.