This research will inform the final design of the Exact Sciences Cancerguard test. Credit: Studio Romantic via Shutterstock.

Exact Sciences has unveiled new findings from a case-control study demonstrating the potential of its advanced multi-biomarker class approach to improve early-stage and overall cancer detection. 

The study evaluates a multi-cancer early detection (MCED) test that integrates DNA mutation reflex with methylation and protein (MP) markers. Results indicate significant improvements in early cancer detection, with 28% sensitivity increase for stage I cancers and a 12.5% boost for early-stage cancers (stages I and II), excluding breast and prostate cancers. The refined MCED test maintains 98.5% specificity.  

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The data will be presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Liquid Biopsy 2024, held from 13 to 16 November in San Diego, California. 

This research will inform the final design of Exact Sciences’ Cancerguard test, which leverages the additive sensitivity of multiple biomarker classes to detect a broader range of cancers at earlier stages. Exact Science’s chief medical officer Tom Beer said: “The new data answer key questions about the impact we can anticipate with MCED testing if integrated into clinical practice.” 

Cancerguard is being evaluated in the ongoing ASCEND-2 study, which previously demonstrated promising results. At the AACR’s annual meeting in San Diego in April 2024, data from ASCEND-2 showed the blood test achieved 50.9% sensitivity at 98.5% specificity across 21 cancer types. Additionally, sensitivity rose to 63.7% in the six types with the shortest five-year survival rate, including lung, ovary, and pancreas. 

Additionally, Exact Science’s is conducting DETECT-A, a large-scale prospective study of an MCED test using a multi-biomarker class approach. Enrolling over 10,000 participants with more than four years follow up, this study evaluates the earlier CancerSEEK test, a precursor to the Cancerguard test.  

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New findings from DETECT-A show that MCED testing complements existing lung cancer screening guidelines without negatively impacting adherence to standard care practices. Exact Science’s MCED technology uses a single blood draw to analyse circulating tumour DNA (ctDNA) for cancer-specific mutations. The test focuses on methylation and protein biomarkers that capture common, cancer-associated signals, which are released into the blood through different biological mechanisms. 

Beyond MCED, Wisconsin-headquartered Exact Sciences has a range of different diagnostic tests, including Cologuard for colorectal cancer (CRC) screening. In October 2024, the Nasdaq-listed company received US Food and Drug Administration (FDA) clearance for Cologuard Plus, the second generation at-home colorectal cancer test for adults aged 45 and older.