CMS withdraws revocation of CLIA certificates and reduces civil monetary penalty; Theranos withdraws appeal, completing exit from the clinical lab business
PALO ALTO, Calif. – [April 17, 2017] Theranos, Inc. announced today 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 Pursuant to the terms of the settlement, CMS has withdrawn the revocation of the company’s CLIA operating certificates and reduced its civil monetary penalty against the company to $30,000.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.
Founded in 2003 by Elizabeth Holmes, Theranos, Inc. is a health technology company headquartered in Palo Alto, Calif. Its proprietary miniLab platform is designed to enable earlier disease detection and intervention by facilitating low-cost, small-sample collection, testing, and rapid communication of diagnostic information in distributed settings. To learn more about Theranos, visit www.theranos.com.