Exact Sciences Corp. announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard®? test met all study endpoints, demonstrating 94% sensitivity for colorectal cancer (CRC) at 91% specificity, during the American College of Gastroenterology (ACG) Annual Meeting 2023.

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). Finally, the next-generation Cologiard test demonstrated higher sensitivity for the most clinically significant form of advanced precancerous lesions (high-grade dysplasia at 75%) than FIT (47%). In addition to superiority over FIT in sensitivity for both colorectal cancer and advanced precancerous lesions, the next-generation Cologicuard test demonstrated 91% specificity.

The specificity for FIT was 95%. In addition to the BLUE-C pivotal data shared at ACG, Exact Sciences presented an analysis that describes a performance evaluation and validation of the next-generation Cologinard algorithm using a set of known test samples from the original Cologuard pivotal study (DeeP-C). 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 (N=20,176). The Cologuard tests results should be referred for colonoscopies.

The Cologuard test results should be referred for colonscopy (CRC) at the endpoints. The Cologuard tests was a critical step in advancing the detection and prevention of colorectal cancer and pre-cancers. BLUE-C is one of the largest, most robust CRC screening trials ever conducted.

Most advanced Next-gen FIT colonoscopy Cologuard (N=20,176) finding (index (N=20,176); Stage I-III 93 65; Advanced Pre- 43 23; Cancerous Lesions (APLs) High-grade 75 47; dysplasia (APLs). Note: FIT positivity cut-off: hemoglobin >100 ng/mL. Colorectal cancer stages were defined per the American Joint Committee on Cancer Staging System, 8th ed.

BLUE-C Reports High Specificity: In addition to superiority over F IT in sensitivity for both coloreCTal cancer and advanced precanceral lesions, the next- generation Cologuard test demonstrated 91% specific specificity for FIT was 95%. The specificity for FIT was95%. 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.

For patients with a negative or non-neoplastic findings on colonoscopy, specificity for the next-generation Cologenard test reached 93%. In this category, the specificity for FIT was 96%. In addition to the BLue-C pivotal data shared atACG, Exact Sciences provided an analysis that describes a performance evaluated and validation of the next- generation CologUard algorithm using a set of available test samples from the original Cologicard pivotal study (Dee PIT).

The Cologuard testing results should be interpreted with caution. Patients with a positive test results should be referred for colorectal cancer screening.