New Multi-Biomarker Class Approach Improves Cancer Detection

Cancer is expected to become the leading cause of death in the U.S. by 2030. Only about 14% of all cancers in the U.S. are detected through screening, highlighting a significant gap in patient care. Multi-cancer early detection (MCED) testing presents the most promising opportunity to address this issue. Now, recent findings from three studies highlight significant progress in developing an MCED test.

Exact Sciences (Madison, WI, USA), a leading cancer screening and diagnostic solutions provider, presented three abstracts at the AACR Special Conference in Cancer Research: Liquid Biopsy. These studies provide encouraging data on the potential of an MCED test. One of the studies evaluated a new multi-biomarker class approach and demonstrated improved sensitivity for detecting early-stage and overall cancers. The study showed that incorporating a DNA mutation reflex approach with methylation and protein (MP) test results in the MCED test increased early-stage cancer sensitivity. Specifically, the test improved sensitivity by 28% for stage I cancers and 12.5% for early-stage cancers (stages I and II) at a 98.5% specificity rate in a case-control study. This highlights the potential of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) test for better-detecting cancers at earlier stages.

This research contributes to the ongoing development of Exact Sciences' Cancerguard test, which aims to utilize the combined sensitivity of multiple biomarker classes to detect more cancers in their early stages. The Cancerguard test is designed to detect multiple cancers from a single blood draw in their earliest stages. Building on decades of research, Exact Sciences seeks to improve early detection by using a multi-biomarker approach. The test will feature a streamlined and standardized imaging-based diagnostic pathway, potentially reducing the need for follow-up procedures. It will also focus on high specificity to minimize false positives while detecting a range of cancers, particularly those with the greatest impact on health.

Moreover, new modeling data suggests that adding MCED testing to recommended screenings could significantly reduce the incidence of stage IV cancers and, consequently, cancer mortality over the next decade. The modeling predicts a 42% reduction in stage IV cancer incidence and a 17% decrease in 10-year cancer mortality with the integration of MCED testing into standard care. Another analysis from the DETECT-A (Detecting Cancers Early Through Elective Mutation-based Blood Collection and Testing) study indicates that incorporating MCED testing enhances guideline-recommended lung cancer screenings without reducing adherence to current practices. The DETECT-A study, which enrolled over 10,000 women with no prior cancer history, was the first large, prospective, interventional study to use a blood test for detecting multiple cancer types in a real-world setting. The CancerSEEK test, the MCED test used in DETECT-A, is a precursor to Exact Sciences’ Cancerguard test, now under development.

“The Exact Sciences team is committed to taking a rigorous, comprehensive approach to multi-cancer screening. The new data answer key questions about the impact we can anticipate with MCED testing if integrated into clinical practice,” said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences.

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