In October, consumer genetics testing company 23andMe released its first transparency report, which revealed that government agencies had requested information on four customers. None of the requests were filled. According to the company's privacy officer, Kate Black, only two of the requests were valid, and the company was able to fight them on “procedural and substantive grounds.” Whether all such requests can be denied is not clear. Bradley Malin, director of the Health Information Privacy Laboratory at Vanderbilt University in Nashville, says that requests must be specific. “They can't just say 'Do you have a DNA sequence that looks like this?', as it requires a search across the entire database, at which point, you're basically requesting information on the entire resource,” he says. But, he points out, companies can decide whether or not to respond. “If they believe that the information they may have is going to solve something that is not going to have implications on the welfare of their consumers, they might respond to it,” Malin says. From her perspective, 23andMe's Black says, “We don't see any public interest or positive outcome of transferring information, especially [given] the nature of DNA and our genetic database. I can't think of any scenarios under which we would comply.”

Also in October, 23andMe resumed its personal genome testing offering, after the US Food and Drug Administration told the company it would not require pre-market review for a limited number of tests. This ruling was anticipated since February, when the Mountain View, California–based company gained approval to market a single test (Nat. Biotech. 33, 435, 2015), Bloom syndrome carrier test, after providing extensive documentation. The agency had in November 2013 directed the company to stop selling its screening tests because of failure to obtain marketing clearance. With the recent go-ahead, the agency has enumerated a few requirements, among them that the customer must be given information on counseling services, and must be provided access to information on the validity of each variant, which can come from the peer-reviewed literature or professional society recommendations. 23andMe now offers 36 genetic carrier tests—many affecting small populations—including cystic fibrosis, sickle cell anemia and thalassemias, albeit at a slightly higher price than their previous genetic panel ($199, previously $99).