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Beckman Coulter Genomics' BRAF Assay Receives State Licensures

NEW YORK (GenomeWeb News) – Beckman Coulter Genomics today said that three states have licensed its BRAF assay, expanding the availability of the test.

Pennsylvania, Maryland, and Rhode Island have granted clinical laboratory licenses to Beckman Coulter Genomics for the assay, which is CLIA certified. Massachusetts licensed the assay last year, and of the seven states that require licensures in addition to CLIA certification for certain tests to be offered there, Florida, California, and New York remain the only ones that have not licensed Beckman Coulter's BRAF assay.

The company said that applications to those three states are pending.

The BRAF assay uses Sanger sequencing to detect BRAF exon 11 (codons 439-477) and exon 15 (codons 581-620) mutations. The test is the first clinical molecular diagnostic assay offered by Beckman Coulter Genomics for the CLIA laboratory, the Danvers, Mass.-based company said.

"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," Beckman Coulter Genomics VP of sales and marketing Bernhard Spiess said in a statement. "These assays will provide great clinical value to physicians and clinical researchers, furthering their understanding of how genetic factors impact disease and improving the efficacy of treatments."