Certitude Disclaimers

I understand and agree that:

• I am 18 years of age or older.
• I have read and agree to the Certitude Terms of Service and Privacy Policy.
• I will receive my test results and related records through the Certitude Patient Portal. I can request a copy at any time by emailing certitude.inquiries@astrinbio.com.
• My healthcare provider has ordered the Certitude Breast Cancer Screening Test for me, or I am requesting the Certitude Breast Cancer Screening Test. If I am requesting a test, a licensed clinician from a telehealth medical group will review my request and decide whether to order the test. That clinician will decline if I do not meet the clinical criteria.
• Certitude is a laboratory developed test performed by Astrin Biosciences in its CLIA certified laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration.
• My result is produced using computer based algorithms, including artificial intelligence. It is intended to support, not replace, my clinician’s judgment. My clinician will interpret my result and advise me on next steps.
• To perform my test and deliver my result, my information will be used and shared with the ordering clinician and their medical group, the group that collects my blood sample, and Astrin’s laboratory. It will not be shared with anyone else for these purposes.
• After my testing is complete, Astrin removes the information that identifies me from what remains of my blood sample and may keep it indefinitely. Astrin uses my de-identified sample and test data for the laboratory quality testing, including those required to maintain its CLIA certificate and CAP accreditation.
• I can ask Astrin to destroy my sample, in my account settings or by emailing certitude.inquiries@astrinbio.com, until it is de-identified, which will occur no earlier than 30 days after my test result is issued. Once de-identified, my sample cannot be re-identified to be destroyed. My request will not apply to information or analyses generated from my sample prior to my request or incorporated into de-identified or combined datasets.
• Astrin and my clinician may contact me about my test by email, phone or text at the contact information I provide. This includes my results, next steps, and reminders when I am due to retest. These messages are not appropriate for urgent or emergency needs. For those I will contact my healthcare provider or 911.
• My clinical record from any telehealth visit is held by the clinician’s medical group, and I can request a copy from them.
• I can withdraw this consent at any time, although Astrin cannot undo testing that has already been performed.