Geneoscopy, Inc.
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.
Inclusion Criteria: * Subject is male or female, ≥45 years of age (subjects aged 18-45 can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis) * Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form * Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure * Subject is able and willing to undergo a colonoscopy after providing…
multi-target stool RNA test
Arctuva estimate
Verify or correct the compensation shown for this listing.