Bernhard SpiessBernhard SpiessThe BRAF assay from Beckman Coulter Genomics, Danvers, Mass, 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.

“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,” says 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.”

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.  

Applications for approval in Florida, California, and New York, the remaining states that require licensure in addition to CLIA certification, are pending.

[Source: Beckman Coulter Genomics]