Certitude

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Certitude

1000 Westgate Drive
St. Paul, MN 55114

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The Certitude Test is a laboratory developed test (LDT) from Astrin Biosciences Inc., and is performed by Clinical Laboratory Improvement Amendments (CLIA) certified, College of American Pathologists (CAP) accredited laboratories qualified to conduct high-complexity clinical testing and is only intended for use consistent with applicable CLIA and CAP requirements. The Certitude test performance characteristics were validated by Astrin Biosciences following CAP and CLIA regulations. When offered as an LDT, the Certitude Test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).