Wednesday, February 1, 2012

Foundation Medicine gets OK for sequencing lab

By Lori Valigra

Foundation Medicine Inc., a cancer genome analysis company, said today that it has received certification for its genomic sequencing lab in Cambridge.

The so-called Clinical Laboratory Improvement Amendments (CLIA) clearance was granted by the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services. The certification allows the company to accept clinical samples from most U.S. states. It follows receipt of a Massachusetts State license last October.

“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,” Dr. Kevin Krenitsky, chief operating officer at Foundation Medicine, said in a statement.

The company said it has started accepting clinical samples, and expects to commercially launch its genomic profile for patients with solid tumors in mid-2012.

The CLIA regulation was enacted in 1988 to assure consistent, accurate and reliable clinical test results reporting from labs nationwide that are used for the diagnosis, treatment and/or prognosis of human diseases. CLIA applies to all clinical laboratories operating in the United States and its territories, topping 200,000 clinical testing sites.

Foundation Medicine’s cancer genomic test analyzes routine clinical samples for all genomic alterations in about 200 cancer-related genes, the company said. The test is reportedly optimized for clinical-grade tumor tissue analysis. The results are designed to help physicians evaluate cancer treatments tailored to each patient’s molecular subtype.

Foundation Medicine in January announced a partnership with Sanofi, in which it will use its genomic analytics technology to identify biomarkers and companion diagnostics for Sanofi’s cancer research.