FDA Clears Theranos' HSV-1 Finger Prick Test and System

Megan Brooks


July 06, 2015

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Theranos Inc's test and test system for herpes simplex virus-1 (HSV-1) immunoglobulin G, the company has announced.

The clearance covers the Theranos System, which includes the company's finger stick and venous blood test, its patented Nanotainer tubes used to collect tiny amounts of blood, and analytical software, the company said.

The Theranos System is a highly automated platform designed to "mitigate the human error traditionally associated with the manual processing of samples," the company said in a news release.

The FDA reviewed study data from 818 subjects of varying age and ethnicity, demonstrating that the Theranos System "could be run accurately using only a finger stick as well as a traditional venous draw across large numbers of Theranos devices, all compared against an FDA cleared, commercially available reference method," the release notes.

"Theranos also completed full submissions for its HSV-1 [immunoglobulin G] test on venous serum, venous plasma, capillary plasma and capillary whole blood, to demonstrate equivalence on its system across the different sample types, in contrast to conventional tests which have only been cleared for venous samples," the company said.

Theranos' HSV-1 test costs $9.07.


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