July 2, 2015 | The FDA announced its approval of a Theranos test for the sexually transmitted disease herpes simplex virus (HSV-1) and--more importantly--approval for the Theranos platform. The FDA clearance includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger, the company said in a press release. "The Theranos System, including Theranos’ device, analytical software, and Nanotainer Tubes, has been fully validated and cleared for use with this test method." The company has been notoriously tight-lipped about the technology behind its platform, and skeptics have argued that the "nanotainer" amounts of blood, in particular, couldn't be accurate. "At least in the context of the HSV-1 test, these studies concluded that Theranos’s finger-stick tests on either whole blood or plasma were at least as accurate as the conventional FDA-approved reference test performed on blood serum or plasma drawn by venipuncture,"
Fortune notes.