Exact Sciences Presents Data Demonstrating Advancement in Blood-based Colorectal Cancer Screening at ESMO 2024

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced performance data for its blood-based colorectal cancer (CRC) screening test. Results show sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy. Results were presented today at the European Society for Medical Oncology (ESMO) Congress in an oral presentation titled, “Organ-specific performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively-collected cohort.”

“The Exact Sciences team is constantly innovating to help close the screening gap,” said Kevin Conroy, chairman and CEO, Exact Sciences. “The insights that led to this innovation reflect our understanding of the biology of cancer and the power of our scientific capabilities. We took a unique scientific approach to developing this test by combining a novel panel of markers. This led to data that improve upon what we previously thought was possible with a blood-based colorectal cancer screening test.”

To optimize the final test algorithm, Exact Sciences designed a study to simulate the screening population in the United States and better predict real-world, prospective performance of a novel test. The study consisted of more than 3,000 blood samples, including approximately 2,900 blinded, prospectively collected samples from the pivotal BLUE-C study. This analysis was prespecified with the U.S. Food and Drug Administration (FDA) and the samples will be excluded from the final clinical validation. The study also included more than 90 advanced precancerous lesions, the majority of which were prospectively collected, and 60 case-collected colorectal cancer samples. In the pivotal BLUE-C study results, performance degradation is expected for advanced precancerous lesion sensitivity and overall CRC sensitivity.

Results of this study show the potential of a novel, highly discriminate blood-based panel of methylated DNA markers and an impactful, new marker class to detect advanced precancerous lesions and cancers at an attractive cost profile. The company will implement the innovative marker class on a new testing platform and complete additional analytical studies to support an FDA submission.

“A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field,” said Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences. “Results from this large, well-designed study show progress toward that goal and move us one step closer toward providing average-risk patients with another non-invasive screening option.”