Beckman Coulter reports that it will begin accepting clinical samples for genetic sequencing. The company has obtained a CLIA certificate of registration along with Massachusetts State Licensure.
This certification paves the way for detection of BRAF exon 11 (codons 439–477) and exon 15 (codons 581–620) for mutations using PCR-based DNA sanger sequencing, the first clinical molecular diagnostic assay the company has developed. Plans call for Beckman Coulter Genomics to develop further CLIA-certified assays using next-generation sequencing for a number of 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 a greater numbers of patients,” says Joseph Repp, vp and GM of Beckman Coulter Genomics. “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.”
Beckman Coulter, based in California, develops, manufactures, and markets products that simplify, automate, and innovate complex biomedical tests. The firm says that more than 275,000 of its systems operate in both diagnostic and life science laboratories on six continents.