Theranos' finger-stick blood testing gets FDA approval

Marco della Cava | USA TODAY

SAN FRANCISCO — In a ringing endorsement of its technology and a counter to its critics, Silicon Valley bio-tech company Theranos announced Thursday that its proprietary blood-testing system has received clearance from the Food and Drug Administration.

The FDA has granted approval to Theranos' finger-stick method and, more specifically, for its testing of the herpes simplex 1 virus.

"In order to realize our vision of early detection, lab tests must meet the highest quality standards, standards that are comprehensively set by FDA," founder Elizabeth Holmes said in a statement.

"FDA review is a uniquely rigorous process we undertook voluntarily because we remain deeply committed to ensuring that our systems and all of our laboratory developed tests are of the highest quality, and that patients and their physicians have access to the most accurate information about their health."

Theranos was founded in 2003 by Stanford dropout Holmes. It ran in stealth mode for a decade while perfecting a method of running complex blood tests based not on vials of blood but rather a mere drop or two. For the past year, the company has been operating dozens of labs in Walgreens Wellness Centers in Arizona, as well as another near its headquarters in Palo Alto, Calif. It aims to eventually roll into all of Walgreens' 8,200 stores.

The long-stated mission of Holmes, 31, who is a billionaire on paper due to the company's $9 billion valuation, is to empower patients to take control of their own health by providing inexpensive blood testing that — if interpreted by physicians in a timely manner — can catch diseases in their earliest stages.

Theranos' HSV-1 test costs $9.07 and is one of 153 tests Theranos makes available for less than $10.

Bloodwork labs do not need FDA approval, but Theranos has been working with the agency since 2013 to seek its regulatory approval. That hasn't stopped some industry observers from taking the company to task for its secrecy; it has not revealed any information about how its machines run sophisticated tests based on a significantly reduced amount of patient blood.

A few months ago, Stanford School of Medicine professor John Ioannidis accused the company in a Journal of the American Medical Association editorial of practicing "stealth research" and called for a more transparent company policy.

The FDA approval news is timely for Theranos. On July 3, a bill it co-sponsored in Arizona goes into effect allowing patients in that state to order their own blood work while protecting doctors from lawsuits, as the responsibility for interpreting the results of the tests lie with patients.