FDA grants first-ever CLIA waiver to herpes test, system

FDA has granted CLIA waiver to Theranos for herpes simplex virus test and test system .

The herpes simplex 1 virus IgG (HSV-1) test and test system were cleared by FDA on July 2, 2015 and have now received a Clinical Laboratory Improvement Amendments (CLIA) Waiver. The waiver allows the use of the test in locations outside of traditional clinical laboratories. This is the first HSV test and test system to receive an FDA CLIA Waiver.

By granting the waiver, FDA has determined that the Theranos test and technology is reliable and accurate and can be used in settings outside of the certified laboratories, including Theranos Wellness Centers. The Wellness Centers are currently located in 42 locations in Arizona, California, and Pennsylvania.

“Receiving this CLIA Waiver is an important milestone in fulfilling Theranos’ mission to provide actionable information at the time it matters,” said Elizabeth Holmes, founder and CEO of Theranos. “Having the ability to make our test and system more broadly available in a variety of settings is critical to our aspirations to contribute to public health, as we continually innovate to provide the best laboratory testing services in the world. The ability for individuals and their healthcare providers to receive test results in near real-time will play a pivotal role in bettering diagnostic and treatment decisions.”

Related: FDA grants first-ever CLIA waiver of rapid syphillis test

This determination is the result of the review of extensive data demonstrating that the test and underlying technology perform at least as well with non-laboratory personnel as by trained operators in a traditional laboratory setting. The manufacturer provided data to prove that certain conditions would not affect the integrity of results reported for the test, including temperature changes, humidity, tilting, and storage and shipping conditions.

Theranos provided study data from 818 subjects, of varying age and ethnicity, that demonstrated 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 a commercially available reference method.  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 equivalence on its system across the different sample types. 

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