Biotech Theranos Gains FDA Approval for New Herpes Test

Biotech startup Theranos notched a regulatory win last week after the Food and Drug Administration (FDA) cleared a new test and analysis system for finding the herpes simplex 1 virus with a single finger prick of blood.

Theranos is headquartered in Palo Alto, California. The company is 12 years old and valued at $9 billion, according to Business Insider. The company’s goal is to disrupt the traditional format of clinical lab testing with a faster, and cheaper, blood test approach while also letting people order these tests no matter what their insurance status is.

The startup announced earlier this morning it signed a deal with health insurer Capital Bluecross to become the insurance company's preferred lab-work provider. Capital Bluecross is Pennsylvania's largest health insurer. This expansion helps Theranos gain a foothold on the east coast because all of the biotech firm's lab-testing services will be made available in central Pennsylvania.

The FDA granted the clearance after reviewing data samples from 818 people “who took herpes tests using a traditional vein-drawn blood sample and blood from a finger stick,” reports Bloomberg Business.

Elizabeth Holmes, chief executive officer (CEO) of Theranos, told the publication the information “showed equivalence” in the accuracy of the test results.

The team at Theranos plans on submitting more lab-developed tests (LDTs) for the agency to review.

However, FierceMedicalDevices notes other rival lab testing companies have raised criticism against Theranos over how the company has not published any data explaining their technology’s efficacy.

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Holmes assured Bloomberg, though, these critiques are “red herrings” because the FDA is currently updating its oversight capabilities for LDTs.

The herpes test will cost $10. No specific details were given as to when this diagnostic would be available, although the company’s other tests are offered at Walgreens stores in Arizona and California as of right now.