Theranos' original big PR splash was when they got FDA 510k clearance on their finger stick test for a herpes (one of the herpes) test. This was a splash for se

Theranos' original big PR splash was when they got FDA 510k clearance on their finger stick test for a herpes (one of the herpes) test. This was a splash for several reasons. One of them was that it technically wasn't needed. At the time of the release, the finger stick test was classified as a 'lab developed test', and FDA rules at that time is that lab developed tests do not have to go through the same approval process of say of standalone diagnostic device or test that would be sold. Essentially under old FDA rules, selling devices and tests were held to a higher level of scrutiny than selling testing as a service. This obvious loophole is in the process of being closed. So assuming that they haven't completely fudged their original 510k submission, what Theranos does have is a finger prick test for herpes. Detection of infectious agents from human samples is typically (not always) an essentially binary process. Many of the issues that we've been hearing about Theranos' tech is an inability to properly quantify (that is provide a number on a continuum) whatever they've been testing for. It is possible that Theranos' tech as is is sufficient for certain types of infectious agents tests beyond herpes simplex. However, it's not at all certain. It'll be a very careful balance of what the sampling error (the fingerstick), the actual limit of detection (of the testing device), and what the clinically relevant threshold is (what concentration of virus/bacteria/antibody) matters.