The US Food and Drug Administration (FDA) has granted clearance for Theranos’ test system and test for herpes simplex 1 virus (HSV-1) IgG.
The approval validates the health technology firm’s patented finger stick and venous blood testing technology and associated Theranos system, upon which the HSV-1 IgG test is run.
According to the company, Theranos system was developed to lessen human error traditionally associated with the manual processing of samples.
The FDA approval comprises use of Theranos’ nanotainer tubes for tests run by this method, enabling collection of samples from a few drops of blood from a virtually painless prick of a patient’s finger.
The agency fully validated and cleared Theranos system, including Theranos’ device, analytical software and nanotainer tubes, for use with this test method.
Theranos founder Elizabeth Holmes said: "In order to realise 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."
Approval was based on study data from 818 subjects of varying age and ethnicity, which showed that the system could be run accurately using only a finger stick, as well as a legacy venous draw across large numbers of Theranos devices.
Theranos’ HSV-1 studies comprised matrix comparison studies across 69 of the firm’s devices.
Additionally, the company also completed full submissions for its HSV-1 IgG test on venous serum, venous plasma, capillary plasma and capillary whole blood, to demonstrate the system’s equivalence across the different sample types, in contrast to legacy tests that have only been cleared for venous samples.