Theranos Gains FDA Approval To Test For Herpes Outside The Lab

You could test your blood for health related disease in the comfort of your home soon. Theranos, the startup that only requires a few drops of blood to test for hundreds of different health-related diseases, received approval from the Food and Drug Administration to test for herpes simplex 1 outside of the lab.

The FDA granted Theranos the ability to test using its proprietary finger-prick method as well as to check for the herpes virus using this method a few weeks ago. Consumers have so far been able to go to their nearest Walgreens Wellness Centers in California and Arizona to get tested.

This new approval, classified as CLIA certificate of waiver, allows testing outside of the lab for those determined to be so simple there is little room for error.

Theranos voluntarily submitted to extensive evaluation from the FDA, which included matrix comparison studies across sixty-nine Theranos devices, according to the Palo Alto startup. The approval also validates the Palo Alto-based startup’s testing process and could open the door for the 152 other tests offered by Theranos in the future.

“We look forward to continuing our strong working relationship with the Agency on further applications,” said Theranos founder Elizabeth Holmes in a statement.