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Foundation Medicine's Cambridge Lab Gains CLIA Certification

NEW YORK (GenomeWeb News) – Cancer genomics testing company Foundation Medicine has received Clinical Laboratory Improvement Amendments certification from the Centers for Medicare and Medicaid Services for its genomic sequencing lab in Cambridge, Mass., the company said today.

The company said it received its Massachusetts license recently and that now with the CLIA certification it is prepared to begin accepting clinical samples from most US states. The firm plans to launch its solid tumor cancer genomic test, which uses next-generation sequencing to analyze clinical specimens for a range of genomic alterations in around 200 cancer-related genes, sometime around mid-year.

The test is optimized for clinical-grade tumor tissue analyses that physicians will be able to use to evaluate cancer treatment approaches based on the patient's molecular sub-type. The tests are used to produce reports that are reviewed by a molecular oncologist and which include scientific and medical literature.

"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 COO Kevin Krenitsky said in a statement.