The US Food and Drug Administration’s (FDA) has approved a test system and test for herpes simplex 1 virus IgG developed by Theranos.
The Theranos System, the company says, has been designed to mitigate the human error traditionally associated with the manual processing of samples. The FDA has approval includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger.
The Theranos System, including Theranos’ device, analytical software, and Nanotainer™ Tubes, has been fully validated and cleared for use with this test method.
“We are proud to have received our first FDA clearance,” said Elizabeth Holmes, the founder and CEO of Theranos.
Theranos provided comprehensive data to the Agency on its test systems and methods, its chemistry, its hardware, and its software in the company’s foundational system and LDT application. Specifically, Theranos provided study data from 818 subjects of varying age and ethnicity, demonstrating that its 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.
Theranos’ HSV-1 studies included matrix comparison studies across sixty-nine Theranos devices. Use of such a large number of devices in the studies is unusual, as such studies are often run on a single or small number of devices. The larger number of devices allows for comprehensive characterization of variation across devices, which can be a source of variance in data across laboratories. Theranos’ HSV-1 clinical studies also included sensitivity and specificity studies with hundreds of human samples – both capillary and venous, CDC panel testing – which demonstrated 100% agreement with the results provided by CDC, low-prevalence population tests, and other studies.
Theranos also completed full submissions for its HSV-1 IgG 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.
Theranos’ HSV-1 test costs $9.07 and is one of 153 tests Theranos makes available for less than $10.
