CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2013—Beckman Coulter Genomics’ BRAF assay has been granted clinical laboratory licenses in Pennsylvania, Maryland, Rhode Island, and Massachusetts.
CLIA certification, plus licensure in those states, allows Beckman to accept clinical samples for genetic sequencing—the most technically complex CLIA category—and provide those results to physicians to use in treating, diagnosing, and preventing disease in patients.
The test uses Sanger DNA sequencing to detect BRAF exon 11 (codons 439-477) and exon 15 (codons 581-620) mutations.
Applications for approval in Florida, California, and New York, the remaining states that require licensure in addition to CLIA certification, are pending.
Beckman Coulter Genomics, 800-742-2345