Caris Life Sciences Receives Tumor Profiling Industry's First ISO 15189 Medical Laboratory Accreditation

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Dec 19, 2013, 08:00 ET

IRVING, Texas, Dec. 19, 2013 /PRNewswire/ -- Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, has announced that its tumor profiling laboratory, located in Phoenix, Ariz., has obtained the molecular profiling industry's first-ever 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' laboratory performs the genomic testing associated with Caris Molecular Intelligence™, the company's comprehensive tumor 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 center 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 tumor."

About Caris Molecular Intelligence™

Caris Molecular Intelligence™ has been the leading cancer profiling service on the market since 2006, having been used 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. Caris Molecular Intelligence™ 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 tumor profiling services, Caris Molecular Intelligence™ more completely interrogates a patient's unique tumor 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 tumor that reveals more fully the complex biological processes that are driving that patient's cancer and, therefore, more, relevant targets for potential clinical action.

With a multi-dimensional profile of a patient's unique tumor, Caris Molecular Intelligence integrates insights from its proprietary and industry-leading evidence curation and bioinformatics platform to identify and report the most clinically relevant associations to drug therapies that are approved by the U.S. Food & Drug Administration or are in active clinical trials in the U.S. Managed by the Caris Evidence Design Board, a dedicated team of oncology experts that includes 5 Ph.D.s and 6 M.D.s, the Caris Molecular Intelligence evidence and bioinformatics platform curates, classifies and catalogues the findings and evidence from all relevant clinical studies in cancer and cancer biology available in the published scientific and medical literature, using a methodology adapted from the evidence review process of U.S. Preventive Services Task Force (www.uspreventiveservicestaskforce.org) of the Agency for Health Research and Quality (www.ahrq.gov). This platform incorporates the review of more than 100,000 publications and counting. Relying on the most robust evidence that meets Caris' quality standards, the Caris Molecular Intelligence evidence and bioinformatics platform can currently provide therapeutic guidance for up to 43 drug associations with Caris' multi-dimensional approach to tumor profiling, far exceeding the 12 that can be identified using next-generation sequencing alone. The Caris Molecular Intelligence bioinformatics platform electronically delivers the profile and all of these results in an easy-to-use report format that gives oncologists access to underlying evidence, enabling them to develop tailored treatment plans for each unique patient. For more information on Caris Molecular Intelligence™, visit www.carismolecularintelligence.com.

About Caris Life Sciences

Caris Life Sciences is a leading biosciences company focused on fulfilling the promise of personalized medicine. As the first commercial mover in comprehensive molecular profiling in oncology, Caris Molecular Intelligence™ is an industry vanguard, with 50,000-plus patients profiled and counting. Ordered by nearly 6,000 oncologists in 58 countries, Molecular Intelligence correlates molecular data generated from a patient's tumor with biomarker/drug associations derived from clinical cancer literature. Using a variety of advanced and clinically-relevant technologies, Caris provides oncologists with the most clinically actionable information to help them personalize treatment for cancer patients. This multi-technology approach enables Caris to provide therapeutic guidance for 43 drug associations, compared to the 12 that can be found through use of next-generation sequencing alone. The company is also developing a series of blood tests based on its proprietary Carisome^® platform — a revolutionary blood-based testing technology for diagnosis, prognosis, and theranosis of cancer and other complex diseases. Headquartered in Irving, Texas, Caris Life Sciences offers services throughout the U.S., Europe, Australia and other international markets. To learn more, please visit www.carislifesciences.com.

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