The tumor profiling laboratory of Caris Life Sciences has earned accreditation to the standard for “Medical Laboratories: Requirements for Quality and Competence” (ISO 15189), developed by the International Organization for Standardization, in Geneva.
Headquartered in Dallas-Ft Worth, Caris Life Sciences is a bioscience company focused on fulfilling the promise of personalized medicine. The company’s ISO 15189 accreditation—the first ever earned by a laboratory in the molecular profiling industry—was granted to the Caris tumor profiling laboratory located in Phoenix, by the American Association for Laboratory Accreditation (A2LA).
Caris’s laboratory performs genomic testing associated with Caris Molecular Intelligence, the company’s comprehensive tumor profiling service, which has previously profiled more than 50,000 cancer patients worldwide. Along with ISO 15189 accreditation, the Caris lab is also certified by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA), and maintains an extensive list of certifications from the state of New York. The company also operates one of the few commercial biorepositories with accreditation from the College of American Pathologists.
Within the industry, ISO 15189 is considered the most rigorous regulatory standard applicable to clinical laboratories. Accreditation to the standard addresses qualifications and ongoing competency of the company’s laboratory personnel; laboratory accommodation, equipment, reagents and supplies; preanalytical and analytical factors; quality assurance considerations; and postanalytical factors. The ISO 15189 standard is based on previous quality systems standards ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) and ISO 9001 (Quality Management Systems: Requirements), incorporating the quality elements addressed in ISO 9001 certification, as well as the general requirements for a testing laboratory.
“Obtaining ISO 15189 accreditation further demonstrates Caris’s passion for excellence and quality for the benefit of the patient. Our commitment to excellence means delivering accurate results to the physician and keeping the patient at the center of everything we do,” said David D Halbert, Caris chairman and CEO. “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.”
Caris Molecular Intelligence has been used by more than 6,000 oncologists in at least 58 countries to help develop individualized and actionable treatment plans. The service utilizes the most comprehensive range of analytical technologies endorsed by the latest and most robust evidence—immunohistochemistries, fluorescence and chromogenic in situ hybridization, polymerase chain reaction, and next-generation sequencing—to provide oncologists the most complete and clinically relevant profile of a patient’s unique cancer-related biomarkers.
Caris Molecular Intelligence interrogates a patient’s unique tumor biology by going beyond DNA analysis. The service assesses additional important biological components, such as RNA and protein expression levels, to establish a multidimensional profile of a patient’s tumor that reveals more fully the complex biological processes that are driving the patient’s cancer, and therefore offer more-relevant targets for potential clinical action.
For additional information, visit Caris Life Sciences.