BLUE-C Trial Will Make It Even More Challenging for Imitators; Extends Exact Sciences’ Lead in Non-Invasive Colorectal Cancer Detection
Exact Sciences Corp unveiled data from the BLUE-C trial this weekend, showcasing the performance of the next-generation Cologuard® test at the American College of Gastroenterology (ACG) Annual Meeting 2023.
The BLUE-C trial results demonstrated that the next-generation Cologuard test met all its study endpoints, achieving a 94 percent sensitivity for colorectal cancer (CRC) at 91% specificity. What’s more, it significantly outperformed fecal immunochemical testing (FIT) in detecting cancer or precancer, with a sensitivity of 94% compared to FIT’s 67%. The next-generation Cologuard test also exhibited higher sensitivity for the most clinically significant form of advanced precancerous lesions, with a sensitivity of 75%, compared to FIT’s 47%. Notably, the next-generation Cologuard test also exhibited high specificity, reaching 91%. Specificity for FIT, on the other hand, was 95%. BLUE-C encompassed over 20,000 participants, closely representing the racial and ethnic diversity of the United States. Among these participants, 98 individuals with colorectal cancer were identified, with 83.7% of them having stage I to III cancers.
In the original DEEP-C study that was the original clinical validation for Exact Science’s current Cologuard test, the company had 92% sensitivity for cancer and 87% specificity. While the changes in accuracy are relatively small, the clinical implications are large in terms of comparing very favorably with the accuracy of colonoscopy (based upon data from the USPSTF the sensitivity of colonoscopy is 75% to 93% with specificity of 90% to 96). Additionally the test was significantly more accurate for advanced precancerous lesions with sensitivity of 75% versus the original Cologuard at 69%. Given the lengthy development curve associated with colon cancer, serial testing protocols would lead to this real world accuracy being even higher.
Many competitors have such as Guardant Health, Epigenomics, Freenome, VolitionRx, Genoscopy, and others are developing competitive technologies to Exact Sciences but none have demonstrated its accuracy in a large real-world proof of concept study non consisting of well characterized control samples. This study will further extend Exact’s commercial lead.
These findings have ushered in a new standard in non-invasive colorectal cancer and precancer detection. Dr. Paul Limburg, Chief Medical Officer, Screening at Exact Sciences, stated, “BLUE-C results demonstrate a new standard in non-invasive colorectal cancer and precancer detection, building on the strengths of current Cologuard. The high sensitivity and specificity reported in BLUE-C will help drive improvement in patient experiences and will contribute to our quest to improve outcomes for this deadly cancer via accurate early detection.”
In addition to the pivotal data from BLUE-C, Exact Sciences presented an analysis that evaluated the performance and validation of the next-generation Cologuard algorithm using known test samples from the original Cologuard pivotal study (Deep-C). All performance estimates of the next-generation Cologuard were equal to or higher than the first-generation test, affirming reproducibility and the clinically relevant performance of the new iteration.