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Caris gets tumour profiling industry’s first ISO 15189 medical laboratory accreditation

Irving, Texas
Monday, December 23, 2013, 17:00 Hrs  [IST]

Caris Life Sciences, a leading biosciences company focused on fulfilling the promise of personalized medicine, has received molecular profiling industry’s first-ever accreditation for its tumour profiling laboratory located in Phoenix, Arizona to the International Standards Organization (ISO) 15189 “Medical laboratories – Requirements for quality and competence,” accredited by the American Association for Laboratory Accreditation (A2LA).

Caris’ laboratory performs the genomic testing associated with Caris Molecular Intelligence, the company’s comprehensive tumour  profiling service, which leads the industry 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), as well as an extensive list of certifications from the state of New York. The company also operates one of the few commercial biorepositories with College of American Pathologists (CAP) accreditation.

“It is gratifying to receive third-party recognition and verification of something Caris has known – we have the highest quality lab in the industry,” said David Spetzler, Ph.D., vice president, Research and Development at Caris Life Sciences.

Considered by the industry as the most rigorous regulatory standard any laboratory can achieve, ISO 15189 accreditation demonstrates the company’s world-class standard of excellence. This international standard recognizes Caris’ superior level of quality, competence of services and an ability to consistently deliver valid test results. Specifically, this accreditation addresses qualifications and ongoing competency of the 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.

“Obtaining ISO 15189 accreditation further demonstrates Caris’ 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 centre of everything we do,” said David D Halbert, chairman and chief executive officer at Caris Life Sciences. “And the reason this is important to us is that 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 tumour.”

Caris Molecular Intelligence has been the leading cancer profiling service for more than 50,000 cancer patients and counting by more than 6,000 oncologists in at least 58 countries to help develop individualized and actionable treatment plans that seek to improve patient care. It 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.

Unlike other commercially available tumour profiling services, Caris Molecular Intelligence more completely interrogates a patient’s unique tumour biology by going beyond just DNA analysis. Caris’ service assesses additional important biological components like RNA and protein expression levels to establish a multi-dimensional profile of a patient’s tumour that reveals more fully the complex biological processes that are driving that patient’s cancer and, therefore, more, relevant targets for potential clinical action.

 

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