Exact Sciences has announced that its Cologuard colorectal cancer detection test has met all the endpoints and improved every top-line metric in the BLUE-C study.
According to the cancer screening and diagnostic tests provider, Cologuard features novel biomarkers and enhanced laboratory processes. It has been developed in partnership with Mayo Clinic.
The non-invasive screening test is said to come with enhanced sample stability components to offer more time for patients to return their samples to Exact Sciences’ lab and increase the valid result rate.
In the BLUE-C trial, the test showed 94% sensitivity for colorectal cancer at 91% specificity, with a 30% low false positive rate, when compared to DeeP-C, the US Food and Drug Administration (FDA) registrational trial for Cologuard.
Exact Sciences CEO and chairman Kevin Conroy said: “Cologuard is a groundbreaking innovation in non-invasive cancer detection. Next-generation Cologuard will set a new performance standard.
“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 Americans not up to date with screening.”
BLUE-C is a multi-centre, prospective study of around 20,000 adults aged 40 years and above. Its goal is to assess the performance of next-generation Cologuard.
The trial compared multiple screening tests, including next-generation Cologuard and a faecal immunochemical test (FIT) by using colonoscopy as a reference method.
The diagnostic tests provider also collected blood samples for later evaluation of its new blood-based screening test.
Exact Sciences is planning to report additional analyses of the BLUE-C data in the coming months. The firm also aims to complete its application to the FDA for approval of next-generation Cologuard.
In February this year, the company introduced the OncoExTra therapy selection test in the US to offer an overall molecular picture of the patient’s cancer.
