FDA Approves Blood Test from Disruptive Diagnostics Firm Theranos

The U.S. Food and Drug Administration has approved the finger-prick blood test for Herpes Simplex Virus 1 (HSV- 1) developed by startup company Theranos Inc. FDA approval also applies to its hardware, software, and blood-drawing equipment.

Innovative technology created by Theranos allows physicians to use blood collected from a finger stick, creating a less invasive, painful, and costly procedure than conventional blood draw. With just a few drops of blood, a Theranos stick can reportedly scan for dozens of diseases and conditions. The herpes test retails for about $9.07 and is currently sold in 42 Walgreens stores in Arizona and one in California. The traditional HSV- 1 kit costs around $175.

The Silicon Valley biotech company valued at $9 billion dollars announced the approval they received from the FDA Thursday, after coming under fire for operating mainly in secret. To date, few details have been released about the way their tests actually work.

Applying for FDA clearance on such tests remains voluntary. Seeking clearance to prove to the public that their tests were effective, Theranos voluntarily submitted data from 818 subjects. To Theranos, the FDA’s approval is about more than just this one test, noting that it

provides independent validation of Theranos’ patented finger stick and blood testing technology and the groundbreaking Theranos System upon which the herpes test is run.”

CEO Elizabeth Holmes has said that the company’s broadest goal is to advance the cause of preventative medicine by allowing patients to learn of disease before their symptoms manifest. Some expect the disruptive nature of Theranos to make waves in the way consumers experience blood testing.

Read more here- “Theranos Blood Test for Herpes Approved by the FDA” (Rina Marie Doctor, Tech Times)

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Mackenzie is a Marketing Fellow and a rising junior at Villanova University. She is planning to co-major in Marketing and Finance and minor in Business Entrepreneurship. As a part of her studies, she has created and presented a comprehensive marketing plan to professionals from The Vanguard Group featuring Vanguard's exchange-traded funds.


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