Exact Sciences has announced positive top-line data from the BLUE-C trial assessing the performance of the next-generation Cologuard (multi-target stool DNA or mt-sDNA) test.
The data demonstrated that Cologuard met all endpoints of the trial and enhanced every top-line metric, including a 30% less false positive rate, in comparison with the US Food and Drug Administration (FDA) registrational trial for the test, DeeP-C.
Results from the BLUE-C trial showed 94% sensitivity for colorectal cancer, 91% specificity, 75% high-grade dysplasia sensitivity and 43% advanced precancer sensitivity.
The multi-centre, prospective study included more than 20,000 adults aged 40 years and above.
It employed colonoscopy as a reference method and directly compared several screening tests, including next-generation Cologuard and a faecal immunochemical test.
During the trial, blood samples were collected for later assessment of a blood-based screening test that is currently under development by Exact Sciences.
BLUE-C included subjects from different racial and ethnic backgrounds in the US, as per the 2020 census.
In collaboration with Mayo Clinic, Exact Sciences has developed the next-gen Cologuard test that includes biomarkers and enhanced laboratory procedures.
The test also has improved sample stability components to give more time to patients to return their samples to Exact Sciences’ lab, as well as increase the number of valid results.
Exact Sciences plans to conclude the FDA submission for Cologuard by the end of the year.
Exact Sciences chairman and CEO Kevin Conroy said: “Cologuard is a groundbreaking innovation in non-invasive cancer detection. We are harnessing deep scientific insights, advanced technology and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate.
“Once approved, next-generation Cologuard will meaningfully enhance the patient experience and it comes at a critical time – when there are 60 million unscreened Americans.”
