Engineering A PMA Study For A First-Of-Its-Kind Oncology Dx

Background

Colorectal cancer (CRC) is the second most deadly form of cancer – although it is among the most curable and the easiest to detect in its early stages. The reason: patients notoriously avoid colonoscopy, placing themselves at unnecessary risk. Our client developed a unique solution – a multi-target, noninvasive screening test that could be facilitated by patients in their homes. They came to Premier Research to conduct the pre-market approval (PMA) study.

Objective

Premier was asked to determine the sensitivity and specificity of this product using colonoscopy as the reference method, with lesions confirmed as malignant by histopathologic examination, quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and β-actin, plus a hemoglobin immunoassay.