Theranos to Exit Lab Business for Two Years in Deal with CMS

Theranos Inc. announced that it had reached a global settlement agreement with the Centers for Medicare & Medicaid Services (CMS) that resolves all outstanding legal and regulatory proceedings between CMS and Theranos. Pursuant to the terms of the settlement, CMS has withdrawn the revocation of the company’s CLIA operating certificates and reduced its civil monetary penalty against the company to $30,000.
 
As part of the agreement, Theranos affirmed that, consistent with the business plans it outlined last fall, the company will not own or operate a clinical laboratory within the next two years. Theranos exited the clinical lab and retail business last year, and is focusing on its miniaturized, automated testing platforms and related chemistries. The Company looks forward to working with regulatory authorities to secure approval for these innovative technologies.
 
The company is also withdrawing its September 2015 appeal of the sanctions imposed by CMS on its Newark clinical laboratory.