Is there a genetic test for propensity to have a really terrible end of the year? If so, 23andMe co-founder Anne Wojcicki should probably get herself checked out for it.
As of Friday, the Federal Drug Administration blocked the genetics start-up 23andMe from selling any of its popular DNA testing kits—ruining several planned Christmas gifts in the process. In its letter, the FDA said that it was concerned with claims that 23andMe had made regarding its kits ability to detect breast and ovarian cancer and adverse drug reactions. Basically, the FDA threw down the banhammer because it was worried that 23andMe was claiming to diagnose or treat diseases.
And that's hardly the first piece of bad news that the co-founder of 23andMe, Anne Wojcicki has received in the last few months. In late August, the news broke that and her husband, Google co-founder Sergey Brin had separated, and that Brin had become involved with another Google employee. Wojcicki's sister was one of the company's first hires and the nascent company was at one time headquartered in her garage. Google has reportedly invested $10 million in Wojcicki's company.
Though the genetic analysis offered by 23andMe was named Time magazine's invention of the year in 2008 and has raised more than $100 million in investor funding, it appears that it may have run afoul of the FDA as it tried to scale up its growth. According to ExtremeTech, the company has increased the number of conditions, drug responses, disease risks, and specific traits that it says it can identify by 25% in the last two years. Perhaps worse, the FDA claims that it has received no communications from the company about its concerns for the last six months.
23andme has received support from genetic libertarians opposed to the FDA action, including Reason magazine, which called the ban outrageous. A petition in support of 23andMe on change.org from the group TechFreedom has gained almost 2,000 signers.
There's signs that Wojcicki may be regrouping. In a statement posted on their website yesterday, 23andMe said that, "we are committed to fully engaging with them to address their concerns." And a few weeks ago, to celebrate her separation, threw herself a "freedom" party on Alcatraz island.