Beckman Coulter, Inc. has obtained a CLIA Certificate of Registration, along with Massachusetts State Licensure, allowing Beckman Coulter Genomics to begin accepting 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.
This milestone 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 greater numbers of patients," said Joseph Repp, vice president and general manager 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."