Theranos has received approval from the US Food and Drug Administration (FDA) for its finger-prick blood test for HSV-1 herpes.
Theranos’ technology is of interest because instead of a conventional blood draw with a needle and vial, needing a trained phlebotomist and healthy veins, physicians can use blood collected from a finger stick , a far less invasive, painful and costly procedure.
The Silicon Valley biotech company, criticized for its “stealth research“, last week also applauded Arizona’s new Direct Access law, which gives patients in the state the ability to get and pay for directly any lab test from a licensed lab without the need for a health care provider’s order or to work out insurance eligibility.
Theranos’s herpes blood test costs $9.07, and is currently sold in 42 Walgreens stores in Arizona and one in California, according to the Washington Post.
Some academic researchers have criticised Theranos’ secrecy concerning how its technology works, with several scientists saying that basic questions about how its technology compares to other products on the market remain unanswered.
Stanford University’s John Ioannidis wrote in an e-mail to The Washington Post:
“I think that getting FDA clearance is a step in the right direction, and Theranos should be congratulated for doing this. However, I still believe that it is important also to have the full information available in the scientific community through peer-reviewed publications on methods and results.”
“Theranos may have taken the latest existing technology and tweaked and refined it into a unified system that’s more streamlined and more elegant than any existing system, creating a disruptive lab business.”
A representative for Theranos provided the following statement to Business Insider:
“The FDA, which is the ultimate arbiter of safety and efficacy — of high quality tests that are proven to work — is the gold standard, and Theranos wants its tests to be the best and safest for its patients. We have called for an unprecedented level of review with the FDA, something we are not obligated to do. We’ve been submitting all of our tests to them and are committed to continuing to do so.”
And a statement The College of American Pathologists said that it could not comment on the technology, because they had not reviewed it.
“Any laboratory using any FDA-approved test must validate it in their own environment,” R. Bruce Williams, chairman of the College’s Council on Scientific Affairs, said. “However, the ability to draw less blood and spend less resources to obtain an accurate laboratory result is a positive diagnostic achievement.”