Approval Brings CLIA Certified Test to 47 States
The BRAF assay from Beckman Coulter Genomics has been granted clinical laboratory licenses in four states, expanding the availability of the offering that last year received CLIA Certificates of Registration and Compliance. Pennsylvania, Maryland and Rhode Island, three of the seven states that require statewide licensure in addition to CLIA certificates, have approved the test, joining Massachusetts, which licensed the assay last year.
CLIA certification, plus licensure in the named states, allows Beckman Coulter Genomics to accept clinical samples for genetic sequencing – the most technically complex CLIA category – and to provide those results to physicians for their 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 and is the first clinical molecular diagnostic assay to be offered by Beckman Coulter Genomics for the CLIA laboratory.
“Looking ahead, the plan is to develop CLIA-certified assays using Sanger and next generation sequencing technologies for the study of cancer and infectious and hereditary genetic diseases,” said Bernhard Spiess, vice president of sales and marketing, Beckman Coulter Genomics. “These assays will provide great clinical value to physicians and clinical researchers, furthering their understanding of how genetic factors impact disease and improving of the efficacy of treatments.”
Applications for approval in Florida, California and New York, the remaining states that require licensure in addition to CLIA certification, are pending.