A reliable provider of DNA sequencing services, Beckman Coulter Genomics recently received accreditation from the College of American Pathologists. The accreditation will help the company more quickly move its findings from clinical trials into clinical application.
Beckman Coulter Genomics’ facility in Danvers completed a comprehensive on-site inspection as part of the CAP’s Accreditation Programs. This respected accreditation is expected to strengthen this leading firm’s already strong bioinformatics expertise and extensive experience in study design, guidance and analysis of customer’s crucial clinical samples.
Dr Stephen Lyle, laboratory director at Beckman Coulter Genomics, said, "CAP accreditation signifies that our lab operates under rigorous quality standards to generate highly accurate and reliable data. We are pleased to be able to provide our customers a sequencing service which satisfies the exacting requirements of regulatory authorities and will help the facility more quickly move findings from clinical trials into clinical use".
Recognized as the ‘high-water mark’ for laboratory testing, the CAP Laboratory Accreditation Program aims at improving patient safety by advancing the quality of pathology and laboratory services through education, standard setting, and ensuring laboratories meet or exceed regulatory requirements. Upon successful completion of the inspection process, the laboratory is awarded CAP accreditation and becomes part of an exclusive group of more than 7,000 laboratories worldwide that have met the highest standards of excellence. The CAP Laboratory Accreditation Program involves a process of inspections of clinical lab records and quality control procedures and assessments of a lab’s staff qualifications, equipment, facilities, safety program, and overall management.
In January, Beckman Coulter made headlines when the Food and Drug Administration (FDA) granted 510(k) clearance for the company’s 25(OH) Vitamin D Total assay. Standardized to the reference measurement procedure from Ghent University in Belgium, this new assay offers excellent stability, reproducibility and accurate clinical assessment of vitamin D status.
Beckman Coulter develops, manufactures and market products that simplify, automate and innovate complex biomedical testing such as hematology analyzers, flow cytometers and coagulation analyzers. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories in six continents.