Exact Sciences announces late-breaking data from pivotal BLUE-C trial

Exact Sciences announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard test met all study endpoints, demonstrating 94 percent sensitivity for colorectal cancer at 91% specificity, during the American College of Gastroenterology Annual Meeting 2023. Additionally, results show the next-generation Cologuard test was significantly more likely to detect cancer or precancer than fecal immunochemical testing. Finally, the next-generation Cologuard test demonstrated higher sensitivity for the most clinically significant form of advanced precancerous lesions than FIT. Results show next-generation Cologuard test superior to FIT in sensitivity for colorectal cancer and pre-cancers. 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 Among these participants, the BLUE-C trial identified a total of 98 participants with colorectal cancer. Of these 82 had stage I to III cancers.