Herpes Test For $9 Approved By FDA

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The FDA has fast-tracked a new inexpensive finger-stick test for herpes, as well as a processing system for the test.

The FDA cleared the test under its expedited 510(s) regulatory pathway for low- to moderate-risk devices that are similar to products already on the market.

The $9 test was developed by Theranos, a Palo Alto, California company that has a history of making tests at prices lower that Medicare and Medicaid reimbursement rates, but the herpes test is Theranos’ first FDA cleared device.

Tests of this kind do not generally require FDA approval before being sold, but Theranos submitted its test for premarket review because it “wanted to remain deeply committed to ensuring that [its] systems and … laboratory-developed tests are of the highest quality …” according to Theranos’ CEO Elizabeth Holmes.

Theranos was criticized earlier this year for carrying out “stealth research” — keeping its data under wraps and unavailable for peer-review by journals.

The device, which tests for herpes simplex virus 1, works like most finger-stick tests. The user pricks their finger with a pin attached to a processor which provides a positive or negative reading. The main health benefit of Theranos’ test is one of accessibility: low cost.

Herpes simplex virus 1 is carried by 40 – 60 percent of high socioeconomic populations and 70 – 80 percent of low socioeconomic populations. The most common symptom is blisters that develop on or around the mouth or, less commonly, other areas of the body, which form ulcers when they rupture, during which time the “cold sore” is contagious.

By Cheryl Bretton