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| Theranos CEO Elizabeth Holmes |
Theranos moved a step closer to achieving its vision of providing cheap and rapid point-of-care diagnoses based on a few drops of blood thanks to its first FDA clearance. The agency said the Theranos System can be used to detect herpes simplex virus 1 (HSV-1).
Theranos already performs more than 150 types of tests from its centralized CLIA-certified lab, including the herpes diagnostic, which costs $9.07 to conduct using specimens shipped and collected by healthcare practitioners. But under the current two-track system of parallel regulations, the FDA's clearance enables the HSV-1 IgG test for herpes to be performed at independent facilities--and that's a crucial part of the company's long-term strategy to make diagnostics faster and accessible at pharmacies like Walgreens ($WBA).
"In order to realize our vision of early detection, lab tests must meet the highest quality standards--standards that are comprehensively set by FDA. 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. We look forward to continuing our strong working relationship with the Agency on further applications," Theranos CEO and founder Elizabeth Holmes said in a statement.
The Stanford dropout has a net worth of $4.6 billion, reflecting the impressive financial backing her private firm has received, as well as the promise of its technology, which can make diagnoses in three hours, often with just a few drops blood collected via finger prick.
Theranos said the clearance includes the use of its Nanotainer Tubes, 69 different testing devices and analytical software. It provided the FDA data from 818 subjects of varying age and ethnicity to prove its method's accuracy using a finger stick and traditional venous blood draw. In addition, the diagnostic for herpes was tested using venous serum, venous plasma, capillary plasma and capillary whole blood, according to the company's release touting the FDA clearance.
The HSV-1 IgG test results were found to be in complete agreement with the results of panel tests conducted by the federal Centers for Disease Control and Prevention.
The FDA's plan to replace the so-called CLIA rules (administered by Medicare provider CMS) with its own regulations as the main governor of the diagnostic tests--including those conducted at centralized laboratories--makes the clearance all the more significant. Theranos said it supports the reforms and claims to be the first centralized lab to voluntarily commit to submitting all of its laboratory-developed tests for FDA review.
Other regulatory hurdles need to be cleared for Theranos to expand on the small number of Walgreens pharmacies that provide some of the company's tests in California. The Economist reports that Theranos successfully lobbied for a new law that allows anyone to order a diagnostic test without the need for a doctor's prescription.
- read the release
Special Report: Top women in medical devices 2014 - Elizabeth Holmes, Theranos