Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 virus IgG (HSV IgG) test.
Using a (still largely secretive) lab-on-a-chip technology, Theranos is able to run multiple blood tests on just a few drops of blood, whereas traditional labs need to draw a comparatively large amount of blood and require a different sample for each test. This also allows the company to offer the tests very cheaply, with many available for less than $15. Theranos already has its tests in the market via partnerships with hospitals and with Walgreens pharmacies. Its CEO Elizabeth Holmes has expressed that the company's mission is the democratization of blood testing, allowing people to learn about health conditions early and act on that information.
But the company is also taking steps to make sure the follow-up care is easy to find. Just last week it launched MD Connect, which helps patients connect to primary care physicians to interpret their test results and talk about next steps. The service is currently online in Arizona, and is free for Theranos users and non-users alike. The company also has an iOS and Android app that makes it easier for users to review their data and locate a nearby testing location.
Although the FDA clearance is just for one test, it's the first step in validating hardware and software that Theranos uses widely across its tests, technology that's been kept closely under wraps for the past decade.
“We are proud to have received our first FDA clearance,” Holmes said in a statement. “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.”
The study data submitted to the FDA by Theranos included 818 participants and 69 different devices. Theranos contends that the data proves that blood drawn from the fingertip can provide information as accurately as blood drawn from the veins of the arm, a point of some contention amongst Theranos' critics.
In a profile in the New Yorker last December, Theranos revealed its plans to seek regulatory clearance, despite the fact that currently diagnostic labs are under no obligation to do so. This is something of a regulatory loophole; most diagnostic labs buy their equipment from companies like Siemens or Roche, and those vendors do need to get clearance to sell their devices. But Theranos manufactures its technology and uses it in-house, so it doesn't actually require clearance. The FDA is considering a change to these rules, and even though Theranos has benefitted from the loophole so far, Holmes submitted a comment to the FDA encouraging them to require all testing labs to submit to review.
"Theranos is submitting all of its laboratory-developed tests for review and is working to help create a model for the review of LDTs," she wrote in March to FDA Commissioner Margaret Hamburg. "We believe that our experience as a small and rapidly growing company working with the FDA could be instructive, educational, and of value as the agency continues to develop its regulatory framework for laboratory developed tests. From experience, we know this is the right path for the individual and the physician. And, if a small company like ours can successfully adopt this path, we know it is not an unreasonable burden for others."