BURLINGAME, Calif.--(BUSINESS WIRE)--Color Genomics has received a certificate of accreditation from the College of American Pathologists (CAP) following inspection of its clinical laboratory facility in Burlingame, CA. In order to receive CAP accreditation, a laboratory must demonstrate that it operates with the highest standards of quality, accuracy and consistency. The CAP inspection process investigates several components of the laboratory: assay validation data, quality management program, sample tracking procedures, lab personnel qualifications, facilities, safety, and having a lab that is compliant and ready for inspection.
Color Genomics launched in April 2015 to offer the Color Test: a clinical-grade, physician-ordered genetic test for 19 genes related to breast and ovarian cancer risk, including BRCA1 and BRCA2. All Color testing includes genetic counseling at no additional cost.
The CAP Laboratory Accreditation Program is an internationally recognized program designed to help clinical labs achieve excellence beyond that which is required for regulatory compliance. The goal of the CAP accreditation program is to increase the value that laboratories bring to individuals. The CAP program does this by holding laboratories to a high standard of scientific rigor, accuracy, reliability and consistent quality. Because of its comprehensive nature, the Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority to inspect and accredit clinical laboratories. The program is also recognized by the Joint Commission, and can be used to meet many state as well as international certification requirements.
Color Genomics’ high standards of quality also led to CLIA (Clinical Laboratory Improvement Amendments) certification. In addition, Color was selected as the genomics partner for the multi-year $14.1 million-funded University of California Athena WISDOM study on personalized breast cancer screening. “We’re proud to obtain this accreditation from CAP,” said Dianne Keen-Kim, Ph.D., FACMG, Laboratory Director at Color Genomics. “This recognition demonstrates Color’s unwavering commitment to applying the highest quality testing standards and returning results of exceptional quality, accuracy and reliability.”
CAP #: 8975161
CLIA #: 05D2081492
As the leading organization with more than 18,00 board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP’s Laboratory Improvement Programs, initiated 65 years ago, currently have customers in more than 100 countries, accrediting 7,700 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about CAP at www.cap.org.
About Color Genomics
Color Genomics provides a high-quality, physician-ordered, genetic test for 19 genes related to breast and ovarian cancer risk, including BRCA1 and BRCA2. The Color Test includes support for physicians, as well as genetic counseling as part of every order. Color’s goal is to expand physician-supported access to genetic information for breast and ovarian cancer risk. Find more information about Color at getcolor.com. Follow Color on Twitter: @ColorGenomics.