PALO ALTO, Calif., July 8, 2016 /PRNewswire/ -- Theranos is working closely with the Centers for Medicare & Medicaid Services to resolve the sanctions that the agency advised it plans to impose on the company's Newark, California laboratory and its CLIA certificates. The restrictions have not yet taken effect, and CMS provides 60 days to initiate an appeal. The company is considering all its options and has been in contact with CMS to better understand its findings.
It's important to note that the CMS review pertained to the operations of the company's Newark lab, not its technologies. Over the last 13 years, Theranos has developed a broad range of technologies, including small-volume sample assays, capillary collection and testing capabilities, the ability to test small-volume samples on a variety of different platforms (high-throughput and field devices), and a software suite for testing analysis and decision support. The clinical lab is just one of Theranos' many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes.
While it was obviously difficult to hear the outcome of the CMS findings, we will work non-stop to resolve the issues identified. In an effort to be open with the public and express our continued commitment to realizing the highest standards of quality and compliance, we are sharing the letter from CMS.
Contact: Theranos Public Relations, [email protected]