IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation.
It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the American Association for Laboratory Accreditation (A2LA). In addition to genomic testing, the company runs Caris Molecular Intelligence, a tumor profiling service that has profiled more than 50,000 cancer patients world-wide since 2006.
The ISO 15189 accreditation “demonstrates that we are in full compliance with the most stringent global regulatory requirements applicable to clinical testing laboratories,” stated Randy Vader, the company’s Vice President of Quality and Regulatory Affairs. “each patient specimen, regardless of country of origin, is tested in accordance with our ISO 15189-compliant policies and procedures.”
Serving Markets Worldwide
One reason to pursue accreditation to ISO 15189 is that it demonstrates quality to markets worldwide. “Caris Life Sciences performs all of its testing in its clinical testing laboratory located in Phoenix, Arizona,” Vader said. “Specimens are received from patients around the world, including the U.S., Europe, Middle East, Australia, and other international regions.
“Caris Life Sciences selected A2LA as our ISO 15189 accreditation body because the ISO 15189 accreditation from A2LA is accepted worldwide,” Vader added. “Additionally, A2LA can be counted on to provide the most rigorous ISO 15189 assessment and onsite inspection of all accreditation bodies.”
Besides its long-standing status as a CLIA-approved laboratory and its certifications from the New York State Department of Health, Caris operates one of only a handful of few commercial biorepositories that are accredited by the College of American Pathologists (CAP).
Independent Lab Business
In October 2011, Miraca Holdings Inc., of Tokyo, Japan, paid $725 million to acquire Caris Diagnostics, Inc., the anatomic pathology business division of Caris Life Sciences. The transaction did not include the acquisition of Caris Target Now, the molecular profiling service, or Carisome, a circulating microvesicle technology that was under development at the time. While retaining the profiling service and the circulating microvesicle technology, Caris Life Sciences was organized to operate as an independent company.
In recent years, there has been steady growth in the number of medical laboratory organizations in the united States that have earned accreditation to the ISO 15189 quality management system. Outside the united States, ISO 15189 is used in many countries for lab accreditation.