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The Certitude test was developed, and the performance characteristics validated by Astrin Biosciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. This test has not been cleared or approved by the US Food and Drug Administration. The test is performed at Astrin Biosciences Laboratories. Astrin Biosciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.