NEW YORK (GenomeWeb News) – Beckman Coulter said after the close of the market on Tuesday that it has received CLIA certification and Massachusetts State Licensure, allowing its genomics operations to begin accepting clinical samples for genetic sequencing.
As a result, Beckman Coulter Genomics will be able to provide sequencing results to doctors for the treatment, diagnosis and prevention of disease in patients, it said.
Beckman said that the certification "paves the way" for the detection of BRAF exon 11 and exon 15 for mutations using PCR-based DNA Sanger sequencing. The assay is the firm's first clinical molecular diagnostic assay. Beckman, a Danaher company, added that it plans to develop additional CLIA-certified assays using next-generation sequencing for oncology and infectious disease applications.
"This certification allows Beckman Coulter to work more closely with physicians to bring the promise of high quality molecular diagnostics to benefit greater numbers of patients," Joseph Repp, vice president and general manager of Beckman Coulter Genomics, said in a statement. "We're actively working to bring additional assays to physicians and clinical researchers across the country, as well as help all our customers further their understanding of genetic involvement in disease states."