A device designed to detect colorectal cancer (CRC) has been found to have high detection and sensitivity rates, compared to other commonly used non-invasive tests.

US-based Exact Sciences Corp said that results from the study, published in The New England Journal of Medicine, detail how the use of its Cologuard Plus device saw 94% sensitivity for CRC at 91% specificity.

The Cologuard Plus test also detected a good proportion of the most advanced precancerous lesions and did so with a low number of false-positive test results, according to the principal investigator for the study Thomas Imperiale.

Exact Sciences submitted a pre-market approval application for the device to the US Food and Drug Administration (FDA) in December 2023, including complete results from the BLUE-C study, and pending approval, hopes to make the test available in 2025.

The BLUE-C study (NCT04144738), titled: ‘Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening’ involved 20,000 patients aged 40 and above. Using colonoscopy as a reference method, the study directly compared Cologuard Plus and an independent faecal immunochemical test (FIT), a commonly used non-invasive test used to detect CRC.

Developed in collaboration with the Mayo Clinic, Cologuard Plus introduces new biomarkers and enhanced lab procedures, along with improved sample stability, offering patients extended sample return times and higher result accuracy rates at Exact Sciences’ lab.

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By GlobalData

In the eight major markets (UK, US, Spain, France, Germany, Italy, Japan, and urban China), diagnosed incident cases of CRC are expected to increase from 1,004,915 cases in 2021 to 1,317,175 cases in 2031, at an annual growth rate (AGR) of 3.11%, according to a report on GlobalData’s Pharma Intelligence Center.

In the announcement accompanying the publication of results, Exact Sciences’s CEO Kevin Conroy said: “BLUE-C’s publication in The New England Journal of Medicine reflects a decade of deep scientific and medical research in collaboration with Mayo Clinic.

“We’re eager to bring an improved, non-invasive colorectal cancer screening test to patients in Cologuard Plus, as colorectal cancer remains the most preventable, yet least prevented cancer.”

In November 2023, Labcorp and Geneoscopy teamed up for the distribution of a non-invasive multi-target stool RNA (mt-sRNA) CRC screening test, utilising Geneoscopy’s mt-sRNA biomarker panel to identify CRC and precancerous lesions.


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