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News From the Food and Drug Administration
August 18, 2015

The $9 Herpes Test

JAMA. 2015;314(7):662. doi:10.1001/jama.2015.9405

Within 2 weeks in July, the FDA cleared a new finger-stick blood test to detect herpes simplex virus 1 (HSV-1) and an automated system to process the test and granted the manufacturer a waiver allowing the test to be used outside of traditional laboratories.

Marketing clearance for the test and processing system, developed by Theranos, of Palo Alto, California, was granted though the FDA’s 510(k) process, an expedited regulatory pathway for low- to moderate-risk devices that are “substantially equivalent” to products already on the market (http://1.usa.gov/1I3BLd9).