Eurofins Genomics has received notice of accreditation from the College of American Pathologists (CAP) and certification under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its new laboratory in Louisville, Ky, where the company recently moved its North American headquarters.
“Our new CLIA-licensed and CAP-accredited clinical laboratory offers Sanger sequencing, which is still considered the ‘gold standard’ method for validation of many clinical molecular diagnostic tests, and for confirmation of variants detected by other methods such as next-generation sequencing,” says Martin Kunz, president of Eurofins Genomics. “The new clinical laboratory gains the sequencing expertise already in place at Eurofins Genomics in Louisville, a world leader in fast, accurate Sanger sequencing, and will initially focus on Sanger sequencing services for other clinical laboratories that require sequencing performed in CLIA and CAP regulatory environments.
“Further, as we launch our new oligo synthesis service, customers developing NGS assays can benefit from a one-stop shop that offers cost savings and convenience in ordering both oligos and Sanger sequencing services for the development of clinical tests,” Kunz adds.
CAP accreditation is an internationally recognized standard of operational excellence. The US government recognizes the CAP laboratory accreditation program, begun in the early 1960s, as being equal to or more stringent than the government’s own inspection program. During the CAP accreditation process, designed to ensure the highest standard of care for all patients, inspectors examine the laboratory’s records and quality control procedures. CAP inspectors also examine the laboratory’s equipment, facilities, safety program and record, overall management, and staff qualifications.
CLIA regulations include federal standards applicable to all US facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. To gain CLIA certification, Eurofins Genomics had to demonstrate quality standards for proficiency testing, patient test management, quality control, personnel qualifications, and quality assurance.
For more information, visit Eurofins Genomics.