Help CenterRegulatory & LegalWhat are the key disclaimers I should understand before using OncuraKit?

What are the key disclaimers I should understand before using OncuraKit?

Before using OncuraKit, you should understand these key disclaimers: (1) OncuraKit is a Laboratory Developed Test — it is not FDA-approved or FDA-cleared. (2) OncuraKit is a screening tool — it is not a clinical diagnosis. An Elevated result must be confirmed and evaluated by a licensed physician with appropriate follow-up diagnostic testing. (3) OncuraKit does not have 100% sensitivity — a Normal result does not guarantee the absence of cancer. (4) OncuraKit does not identify the specific tissue of origin — an Elevated result does not tell you which organ the cancer is in. (5) OncuraKit is contraindicated during pregnancy, active cancer treatment, and hormonal therapy. (6) OncuraKit results should not be used as the sole basis for any medical decision. (7) OncuraKit is not a substitute for established standard-of-care cancer screenings.

Answered by OncuraKit Medical Team·Validated against Yenos Analytical published research·Source studies

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