Biosciences company Caris Life Sciences has announced that its tumor profiling laboratory, located in Phoenix, AZ, has obtained accreditation to the International Standards Organization (ISO) 15189 “Medical laboratories—Requirements for quality and competence,” accredited by the American Association for Laboratory Accreditation (A2LA). Caris’s laboratory performs the genomic testing associated with Caris Molecular Intelligence, the company’s comprehensive tumor profiling service, with 50,000-plus cancer patients profiled across the world to date. Along with ISO 15189 accreditation, Caris has also earned accreditation from Clinical Laboratory Improvement Amendments (CLIA). The company also operates a commercial biorepository with College of American Pathologists (CAP) accreditation.
ISO 15189 accreditation addresses qualifications and ongoing competency of a company’s laboratory personnel, laboratory accommodation, equipment, reagents and supplies, pre-analytical and analytical factors, quality assurance considerations, and post-analytical factors. ISO 15189 standard is based on ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) and ISO 9001 (Quality management systems – Requirements) standards, incorporating the quality elements addressed in ISO 9001 certification, as well as the general requirements of a testing laboratory.
Says David D. Halbert, Caris chairman and CEO, “Obtaining ISO 15189 accreditation demonstrates Caris’ commitment to excellence…We are keenly aware that our oncologist clients and their patients are making critical decisions about clinical care and they need to have the most accurate, actionable, and reliable information available based upon each patient’s unique tumor.” Learn more about tumor profiling and other services offered by Caris.
