- The FDA recently showed up at Theranos, which is based in Palo Alto, CA, and told the company that the "nanotainers" the company uses to collect finger-pricks of blood are considered unapproved medical devices.
- Theranos has submitted more than 100 proprietary tests to the FDA for approval, but only one—for herpes— approved.
- Adding to the company's woes, Theranos has also been audited by the Centers for Medicare and Medicaid Services (CMS), which is the main regulatory overseer of clinical labs.
Last week, BioPharma Dive covered the bombshell WSJ article authored by John Carreyyou alleging false claims by the company, as well as the response of Elizabeth Holmes, founder and CEO of Theranos.
The upshot of the article was that Theranos has been misrepresenting its technology, and has only been using Edison, its proprietary blood-testing machine, for about 10% of the tests. In addition, the article pointed to the fact that there have been numerous instances of inaccurate test results, based on the vast differences between results produced by Theranos and those from other, more conventional labs.
And now more fallout: Instead of finger-pricking patients and collecting the blood in nanotainers, Theranos is using the traditional approach to blood drawing and only conducting one test. Holmes has indicated that Theranos is actively working with the FDA to resolve its current problems and move forward.