CardioDx, Inc. announced its onsite clinical laboratory has received accreditation from the College of American Pathologists (CAP), which is awarded to facilities that meet the highest standards of excellence in quality laboratory practices. This recognition adds to the certification of the clinical laboratory previously received from the Centers for Medicare and Medicaid Services' (CMS) Clinical Laboratory Improvements Amendment (CLIA) and to the licensure issued by the New York State Department of Health. CardioDx offers Corus® CAD, the only clinically validated gene expression blood test for evaluating patients with signs and symptoms suggestive of obstructive coronary artery disease (CAD), nationally through its accredited laboratory in Palo Alto, CA.
The CAP Laboratory Accreditation Program is an internationally recognized program and the only one of its kind to utilize teams of practicing laboratory professionals as inspectors. During the accreditation process, inspectors examine the clinical laboratory's records and quality control procedures, as well as the laboratory's equipment, facilities, safety program and overall laboratory management to ensure it meets CAP's stringent requirements. The goal of the CAP program is to improve patient safety by advancing the quality of pathology and laboratory services through education and rigorous standards, which meet or exceed regulatory requirements. CMS has granted the CAP Laboratory Accreditation Program deeming authority. The program is also recognized by the Joint Commission, and can be used to meet many state certification requirements.
"CardioDx is proud to join an outstanding group of more than 7,300 laboratories worldwide that have received CAP accreditation," said David Levison , President and CEO of CardioDx. "This important milestone reflects our commitment to providing the highest quality standards for our clinicians and their patients."