Theranos has been making waves for a few years, but the company known for its finger-prick diagnostic tests has taken major steps in 2015 to bring the technology to the masses. Since lab tests spur much of the clinical decisions made today, access to these tests is central to the company’s mission and founder Elizabeth Holmes’s goal of putting the power of early detection in patients’ hands.
To do this, Theranos has tackled several issues in diagnostic testing this year, including pricing, legal requirements, and regulatory review. In an unconventional move, the company has voluntarily chosen to send all of its tests to FDA for review. Earlier this year, the Theranos diagnostic test and system for the herpes simplex 1 virus IgG (HSV-1) was cleared by FDA and received a CLIA Waiver for use outside of traditional labs.
In another unprecedented step, the company has published its prices for lab tests and made it clear that all patients will be charged the same price, to signal its commitment to transparency, According to the company, these prices are 50-80% below Medicare reimbursement rates.
This year, Holmes also worked with Arizona legislators to pass a law that gives Arizona residents the right to order and pay for a lab diagnostic test on their own, instead of having to secure an order from a physician or get insurance go-ahead first. The company has also partnered with AmeriHealth Caritas to make the diagnostic tests available to Medicaid patients. Theranos tests are now available at over 50 sites and company Wellness Centers in Arizona, California, and Pennsylvania.
[Image courtesy of THERANOS]