This case study outlines a comparison of the performance of a new in-vitro diagnostic (IVD) test for post-colonoscopy in subjects with colorectal cancer and pre-colonoscopy in subjects from a guideline-eligible screening population.

A molecular diagnostics company with a novel IVD test to detect colorectal cancer requested that PRA help rescue a full-service study crucial to its premarket approval (PMA) filing.

The previous contract research organisation (CRO) had missed site and patient enrolment milestones, potentially jeopardising the study’s PMA filing and US Food and Drug Administration (FDA) approval.