The approval validates the firms patented finger stick and venous blood testing technology and associated Theranos System.
Theranos System has been developed to mitigate the human error traditionally associated with the manual processing of samples.
FDA approval comprises use of Theranos’ Nanotainer Tubes for tests run by this method, allowing to collect samples from few drops of blood from a virtually painless prick of a patient’s finger.
Theranos founder and CEO Elizabeth Holmes said: "In order to realize our vision of early detection, lab tests must meet the highest quality standards — standards that are comprehensively set by FDA.
"FDA review is a uniquely rigorous process we undertook voluntarily because we remain deeply committed to ensuring that our systems and all of our laboratory developed tests are of the highest quality, and that patients and their physicians have access to the most accurate information about their health."
According to the firm, the Theranos System, including Theranos’ device, analytical software, and Nanotainer Tubes, were fully validated and cleared for use with this test method.
The approval was based on study data from 818 subjects of varying age and ethnicity, demonstrating that the system could be run accurately using only a finger stick, as well as a traditional venous draw across large numbers of Theranos devices.
Theranos’ HSV-1 studies comprised matrix comparison studies across sixty-nine firm’s devices.
Image: Small cell carcinoma infected with herpes simplex virus. Photo: courtesy of Yale Rosen.
