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Next Generation Cologuard Outperforms FIT for CRC Detection, Shows Improved Sensitivity, Specificity


A pivotal phase 3 clinical trial showed Cologuard significantly more likely than FIT to detect cancerous and advanced precancerous lesions.

A next generation, noninvasive multitarget stool DNA (mt-sDNA) test was significantly more likely to detect cancerous or precancerous lesions than the standard fecal immunochemical test (FIT), according to study findings presented at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, BC.

The results, released during a late-breaking abstract session, showed the Exact Sciences Corp’s newest iteration Cologaurd test met all endpoints in the pivotal phase 3 BLUE-C trial, including a demonstrated 94% sensitivity for colorectal cancer (CRC) at 91% specificity, according to a company statement.

Next Gen Cologuard improves CRC detection / image credit ©sharafmaksumov/stock.adobe.com

BLUE-C included more than 20 000 subjects in a cohort of adults aged 40 years and older that closely reflects the racial and ethnic diversity of the US according to the 2020 census, according to the statement. It is the first head-to-head study of the noninvasive stool DNA test and FIT.

The next-generation Cologaurd test surpassed FIT in detecting neoplasms (93.9% vs 67.3%) as well as advanced precancerous lesions (APLs; 43.4% vs 23.3%). Importantly, the next-generation test also showed higher sensitivity for high-grade dysplasia (75% vs 47%; P < .001), the most clinically significant form of APL, the company reported.

In addition to superiority over FIT in sensitivity for both CRC and APLs, the next-generation Cologuard test demonstrated 91% specificity (vs FIT 95%).

“Improving specificity of non-invasive stool-based screening tests while maintaining high sensitivity is a critical step in advancing the detection and prevention of colorectal cancer and minimizing the potential for unnecessary follow-up colonoscopies,” said Thomas F Imperiale, MD, professor of medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for BLUE-C.

That 91% specificity for persons without advanced neoplasia is greater than the 87% seen in the DeeP-C trial, the FDA registration trial for Cologuard in 2014, according to Exact Sciences. The specificity of the next generation test was 93% for patients with either negative or non-neoplastic colonoscopy findings; FIT specificity was 96%.

In a separate presentation, the company shared findings from a performance and evaluation validation of the algorithm behind the new Cologuard test. For the analysis, the researchers used a set of known test samples from the DeeP-C registration trial and found that all estimates of next generation Cologuard performance were equal to or greater than the first-generation Cologuard, demonstrating reproducibility and also supporting the current test’s performance.

“The findings indicate that the next-generation mt-sDNA test demonstrates even higher sensitivity for colorectal cancer screening (94%) and high-grade dysplasia (75%), compared with the current Cologuard test,” said Seth A. Gross, MD, professor of medicine, NYU Grossman School of Medicine. “These findings suggest that, if FDA approved, the mt-sDNA test will be a valuable option in providing non-invasive colorectal cancer screening.

Developed in partnership with Mayo Clinic, the multitargeted assessment utilizes a trio of novel methylated DNA markers and fecal hemoglobin for the screening of average-risk CRC. Sample stability components have been enhanced, according to the company, to allow patients more time to return their sample.

Exact Sciences plans to release additional analyses of the BLUE-C data in the coming months and to complete its FDA application for approval.

Source: Next generation Cologuard test demonstrates high sensitivity and specificity in pivotal BLUE-C study, significantly outperforming fecal immunochemical testing (FIT) for cancer and precancer detection. News release. Exact Sciences. October 22, 2023. Accessed October 23, 2023. https://www.exactsciences.com/newsroom/press-releases/next-generation-cologuard-test-demonstrates-high-sensitivity-and-specificity-in-pivotal-blue-c-study

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