MADISON -
Additionally, results show the next-generation Cologuard test was significantly more likely to detect cancer or precancer than fecal immunochemical testing (FIT) (94% vs 67% and 43% vs 23%, respectively).[1] Finally, the next-generation Cologuard test demonstrated higher sensitivity for the most clinically significant form of advanced precancerous lesions (high-grade dysplasia at 75%) than FIT (47%).
BLUE-C is one of the largest, most robust CRC screening trials ever conducted. It included more than 20,000 evaluable subjects in a population that aligns to the racial and ethnic diversity of the United States.[1,2] Among these participants, the BLUE-C trial identified a total of 98 participants with colorectal cancer. Of these 82 (83.7%) had stage I to III cancers.
'BLUE-C results demonstrate a new standard in non-invasive colorectal cancer and precancer detection, building on the strengths of current Cologuard,' said
BLUE-C Reports High Specificity
In addition to superiority over FIT in sensitivity for both colorectal cancer and advanced precancerous lesions, the next-generation Cologuard test demonstrated 91% specificity.1 The specificity for FIT was 95%.[1]
'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
The 91% specificity reported in the BLUE-C trial for patients without advanced neoplasia is higher than the 87% specificity reported in Deep-C, the FDA registrational trial for Cologuard.[1,3] For patients with a negative or non-neoplastic findings on colonoscopy, specificity for the next-generation Cologuard test reached 93%. In this category, the specificity for FIT was 96%.
Additional Analysis Presented at ACG Further Supports Performance of Next-Generation Cologuard
In addition to the BLUE-C pivotal data shared at ACG,
'Promising data from the BLUE-C trial involving 20,000 patients is being presented at the
About the BLUE-C Study
BLUE-C was a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older.[1] The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design compared next-generation Cologuard and a fecal immunochemical test (FIT). Blood samples were also collected for later evaluation of a blood-based screening test being developed by
About Next-Generation Cologuard
Developed in partnership with
In the coming months,
About Cologuard
Cologuard revolutionized colorectal cancer screening by providing a convenient and accurate testing option for those at average risk. Nearly a decade later, Cologuard has been used to screen for colorectal cancer more than 12 million times.
Results from
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test.
About
A leading provider of cancer screening and diagnostic tests,
Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the development and commercialization of the next-generation Cologuard test; the performance characteristics of next-generation Cologuard in a commercial setting and the timing and anticipated results of additional analysis of the BLUE-C data and FDA submission. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the
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