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Certitude Disclaimers

Transparency matters. Review the test disclaimers, intended use, and performance notes that guide how Certitude should be used in clinical settings.

General Disclaimer

Disclaimer: The Certitude Breast Cancer Screening Test and its performance characteristics were developed and validated by Astrin Biosciences, Inc., 1000 Westgate Dr., Suite 1009, Saint Paul, MN 55114. CLIA #24D2303035. CAP #: 24D2303035.

This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The Certitude test is performed in a CLIA-certified and CAP-accredited laboratory and is intended for clinical use consistent with applicable CLIA regulations.

Certitude

1000 Westgate Drive,
St. Paul, MN 55114

© Astrin Biosciences 2025. All rights reserved.

Disclaimer: The Certitude Breast Cancer Screening Test and its performance characteristics were developed and validated by Astrin Biosciences, Inc., 1000 Westgate Dr., Suite 1009, Saint Paul, MN 55114. CLIA #24D2303035. CAP #: 24D2303035. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The Certitude test is performed in a CLIA-certified and CAP-accredited laboratory and is intended for clinical use consistent with applicable CLIA regulations.