FDA Approves Exact Science's Cologuard Plus Test After BLUE-C Study

Exact Sciences Corp., a top supplier of cancer screening and diagnostic exams, disclosed that the Cologuard Plus test, the firm's advanced multitarget stool DNA test, was given the approval by the US Food and Drug Administration (FDA). The Cologuard Plus test is now authorized for individuals aged 45 and above with medium risk for colorectal cancer (CRC). FDA approval was granted after results from the significant BLUE-C study, one of the most extensive direct comparison studies in CRC screening, were examined.

Within a group of almost 19,000 average-risk individuals, the Cologuard Plus test showed 95% sensitivity for all cancers and 43% sensitivity for advanced precancerous lesions at 94% specificity, with no abnormalities detected during colonoscopy. Findings from BLUE-C also indicate that the Cologuard Plus test performed much better than an independent fecal immunochemical test (FIT) in terms of overall sensitivity for colorectal cancer, sensitivity for treatable-stage colorectal cancer (stages I-III), sensitivity for high-grade dysplasia, and sensitivity for advanced precancerous lesions.

The company specializing in molecular diagnostics is a top supplier of cancer screening and diagnostic exams that offer patients and healthcare providers the necessary understanding to make impactful decisions sooner. Following the achievements of the Cologuard and Oncotype tests, Exact Sciences is expanding its investments in developing innovative solutions for use in all stages of cancer diagnosis.