Exact Sciences has announced new data from a case-control study highlighting the potential of its multi-biomarker class approach to enhance early-stage and overall cancer detection. The findings were presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Liquid Biopsy 2024. This research is set to inform the final design of Exact Sciences’ Cancerguard test, which aims to detect a broader range of cancers at earlier stages by leveraging the additive sensitivity of multiple biomarker classes.
Enhanced Sensitivity in Early Cancer Detection
The study focused on a refined multi-cancer early detection (MCED) test that combines DNA mutation reflex with methylation and protein (MP) markers. The results indicated a significant improvement in early cancer detection, with a 28% increase in sensitivity for stage I cancers and a 12.5% increase for early-stage cancers (stages I and II), excluding breast and prostate cancers. The test maintained a high specificity of 98.5%.
Cancerguard and ASCEND-2 Study
Exact Sciences' chief medical officer, Tom Beer, stated that the new data addresses critical questions about the potential impact of integrating MCED testing into clinical practice. The Cancerguard test is currently being evaluated in the ongoing ASCEND-2 study. Previous data from ASCEND-2, presented at the AACR annual meeting in April 2024, showed that the earlier CancerSEEK test achieved 50.9% sensitivity at 98.5% specificity across 21 cancer types. Furthermore, sensitivity increased to 63.7% in the six cancer types with the shortest five-year survival rates, including lung, ovary, and pancreas.
DETECT-A Study and MCED Technology
Exact Sciences is also conducting DETECT-A, a large-scale prospective study involving over 10,000 participants with more than four years of follow-up. This study evaluates the earlier CancerSEEK test, a precursor to the Cancerguard test. New findings from DETECT-A indicate that MCED testing complements existing lung cancer screening guidelines without negatively impacting adherence to standard care practices.
Exact Sciences’ MCED technology analyzes circulating tumor DNA (ctDNA) from a single blood draw, focusing on methylation and protein biomarkers that capture common, cancer-associated signals released into the blood through various biological mechanisms.
Exact Sciences' Diagnostic Portfolio
In addition to MCED tests, Exact Sciences offers a range of diagnostic tests, including Cologuard for colorectal cancer (CRC) screening. In October 2024, the FDA cleared Cologuard Plus, the second-generation at-home colorectal cancer test for adults aged 45 and older.
