Theranos expands accessibility of lab testing

PALO ALTO, Calif. — Earlier this month, Theranos continued to lay the groundwork for providing clinical lab resources through the retail pharmacy environment with the U.S. Food and Drug Administration’s clearance of its test system and test for herpes simplex 1 virus IgG. The FDA’s decision provides independent validation of Theranos’ patented finger stick and venous blood testing technology and the Theranos System upon which the HSV-1 IgG test is run.

 

“We are proud to have received our first FDA clearance,” said Elizabeth Holmes, CEO of Theranos. “In order to realize our vision of early detection, lab tests must meet the highest quality standards — standards that are comprehensively set by FDA.”

 

The FDA clearance includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger. The Theranos System, including Theranos’ device, analytical software and Nanotainer Tubes, has been fully validated and cleared for use with this test method.

 

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

 

Two years ago, Theranos and Walgreens opened Theranos Wellness Centers located at Walgreens stores in the Phoenix metropolitan area, at the time marking the first expansion of the new laboratory services outside of California. 

 

That relationship received a boost from Arizona's legislature on July 3 with the passing of the Direct Access law, which enables Arizona patients to obtain and directly pay for any laboratory test from a participating licensed lab without first being required to obtain a health care provider’s order or work through insurance eligibility. “This law is an important milestone in building a health care system that empowers people to take control of their own health and work with their physicians to prevent disease and detect it early, when there is still time to change outcomes,” Holmes said.

 

The legislation that enabled this change makes Arizona the first state to institute this comprehensive framework for laboratory testing, the company stated.

 

Theranos also recently announced its entry into the Pennsylvania marketplace with its partnership with Capital BlueCross, central Pennsylvania’s largest health insurer. “Our partnership with Capital BlueCross is centered on a common mission – to provide access to high-quality, affordable health care, so that people everywhere can own their health and take action to live their best lives," Holmes said. 

 

In Pennsylvania, Theranos testing will be available at Capital BlueCross health and wellness stores, and a network of Theranos Wellness Centers across the region.

 

Theranos test results can be made available to physicians in a matter of hours, enabling fast diagnoses. Tests are low cost — always 50% of Medicare reimbursement rates or less — and are reimbursed by major insurance carriers, Medicare and Medicaid.