- The Centers for Medicare and Medicaid Services (CMS) is now joining the FDA in investigating Theranos’ business practices, following complaints filed by two former Theranos employees (one complaint was sent to the FDA).
- The complaints allege management forced employees to keep testing patients using the nanotainers, which rely on a finger-prick of blood, and the company's proprietary Edison analyzer, even when there were indications of "major instability, precision and accuracy," according to a report in the Wall Street Journal. Theranos has vehemently pushed back on these claims.
- Theranos has faced prior allegations of misrepresenting its lab-testing business. According to an earlier Journal report, its testing analyzer Edison has handled only relatively small percentage of the tests. Instead, most testing is handled by traditional machines, such as those made by Siemens.
Theranos’ regulatory problems have gone from bad to worse. Both complaints from former employees allege Theranos managers were aware of accuracy problems with Edison, but instructed employees to continue with implementing any corrective procedures.
Employees had observed wildly differing results for individual patients on individual tests.
A Theranos lab director, VP Daniel Young, has said he was not aware of pressure from upper management to keep testing if there were errors. He also said Theranos has an internal validation methodology proving the accuracy of Theranos' tests.
But with several agencies now examining Theranos’ testing methods, the diagnostics company will be under even more scrutiny than in the fall.
CORRECTION: A previous version of this piece stated that both the FDA and the FBI were looking into the Theranos claims. This is incorrect - only regulators from the FDA have been examining the issue. The piece has been corrected and we regret the error.