Theranos just received an FDA clearance that’ll allow its newly approved herpes diagnostic to be used outside traditional clinical laboratories. This CLIA Waiver is a sign that the storied single-blood-drop testmaker will be able accelerate its broader market penetration strategy at a much more rapid clip.
Indeed, it’ll help decentralize Theranos’ lab testing services – allowing the highly portable diagnostic to be “provided at the time and places it matters most,” Theranos said in a statement. The company’s aim is to “reinvent” the diagnostics landscape – and by removing the reliance on CLIA-certified labs, it’ll be able to do so more easily in places like, say, the Theranos Wellness Centers embedded in Walgreens.
The FDA evaluated whether the Theranos tests could be run by non-laboratory personnel – and found that it could. For the HSV-1 test, this means that temperature fluctuations, humidity, tilting, power fluctuations, contaminations, and storage and shipping variables didn’t negatively impact testing results for the HSV-1 test.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
A representative for Theranos told MedCity News earlier this month that Theranos has committed to submit all of their diagnostics for FDA review, with well over 100 pre-submissions underway. So, by extension, this CLIA Waiver could ultimately be repeated in the case of many other Theranos tests.
“Receiving this CLIA waiver is an important milestone in fulfilling Theranos’ mission to provide actionable information at the time it matters,” CEO Elizabeth Holmes said in a statement.
