The company announced certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its genomic sequencing laboratory in Cambridge, Massachusetts. This certification follows receipt of a Massachusetts State license and allows the company to accept clinical samples from most U.S. states.
“Foundation Medicine has been dedicated to exceptional standards of operational performance from day one, and that quality commitment was evident in our clinical laboratory certification process,” said Kevin Krenitsky, M.D., chief operating officer of Foundation Medicine. “CLIA certification is a critical step that enables us to accept and report on clinical samples as we scale for full commercial launch later this year.”
Foundation Medicine achieved Massachusetts State licensing in October 2011, enabling the company to begin processing clinical samples from most states. The company has begun accepting clinical samples and expects to commercially launch its fully informative genomic profile for all patients with solid tumors in mid-2012.
Mandated by the Code of Federal Regulations (CFR 42 Part 493.2), the CMS manage and conduct inspections of CLIA laboratories. The regulation was enacted to ensure consistent, accurate, and reliable clinical test results reporting from laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects. CLIA applies to all clinical laboratories operating in the U.S. and its territories and encompasses more than 200,000 clinical testing sites.