Theranos Blood Test: Finger Stick For HSV-1 Detects The Virus

First Posted: Jul 06, 2015 11:44 AM EDT

The U.S. Food and Drug Administration (FDA) has just approved a finger-prick test for the Herpes Simplex Virus 1 (HSV-1) developed by the startup consumer health technology company Theranos, Inc. The review by the regulatory agency was voluntary.

The company announced on Thursday, July 2, that they had received an approval letter for validation of the technology and approach for affordable blood testing that would involve very little amount of patient discomfort as just a few drops of blood from the patient's finger are required.

"This law is an important milestone in building a health care system that empowers people to take control of their own health and work with their physicians to prevent disease and detect it early, when there is still time to change outcomes," Elizabeth Holmes, founder and CEO of Theranos, said in a news release.

To receive clearance for the test, Holmes tested it on 818 subjects, with the release noting that results "demonstrated 100% agreement with the results provided by CDC."

"This (bill) is a major step for Theranos and its plans, and the FDA news does validate Theranos' core competency, but there is still a long road ahead," Eric Lakin, a biotech analyst at DeciBio, told USA Today. "My biggest concerns would be around the interpretation of (blood work) results when there are urgent anomalies."

Theranos' HSV-1 test costs $9.07 and is just one of 153 tests that Theranos makes available for less than $10.

HSV-1, otherwise known as oral herpes, is incredibly common, according to the National Center for Biotechnology Information. The virus enters the body through small cuts, abrasions in the skin or mucous membranes and the incubation period is typically three to six days. Infection results after contact with an infected individual who has been carrying the virus (either with or without noticeable lesions.)

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TagsHealth, Human, Pharmaceuticals, Pharmacy, Herpes, HSV-1, Herpes Simplex 1, Virus, Theranos Inc., Arizona, Voluntary, FDA, U.S. Food and Drug Administartion, America, united states, test, Subjects, Release, CDC, Centers For Disease Control And Prevention, Fingerstick