FDA Approves Finger Prick Blood Tests Patients Can Do Without A Lab

PALO ALTO (CBS SF) -- Blood tests usually require a prescription, a trip to a lab, hypodermic needles, vials of blood, and a followup visit to the doctor's office to get the results.

Palo Alto-based Theranos is revolutionizing the traditional blood test by eliminating the lab, and providing technology that uses a finger prick similar to blood tests diabetics use to measure blood sugar.

On July 2, the Food and Drug Administration approved the company's finger-prick test for patients with type 1 herpes simplex. Now, the company has announced the Department of Health and Human Services has cleared Theranos' tests for use in locations outside clinical laboratories.

Doctors' offices can install the complete Theranos diagnostic system in their offices, and bypass the need for labs altogether. Patients can walk-in, get their finger pricked, and get results, usually within a matter of hours.

Theranos offers more than a hundred different tests, for everything from Lyme Disease to vitamin deficiencies, to STDs. Most tests cost less than $10.

Currently, Theranos operates 42 Wellness Centers in Arizona, one in Palo Alto, and one in Pennsylvania. In Arizona, Theranos has partnered with Walgreens. Patients there can get tested without a lab order from a physician.

Critics of the self-prick testing say patients who forgo laboratory clinicians and doctors, may not understand how to interpret their results, which may lead to misdiagnosis and in the worst case, lack of timely medical treatment and care.

David Koch, a clinical pathologist at Emory University and president of the American Association of Clinical Chemistry is concerned.

"I'm in favor of open access for the patients themselves. Once available, the patient should not wonder about the results, if not have access to them," he said. "The concern is that you need help in interpreting those results and knowing what to do next."