Exact Sciences to Present Late-Breaking Data from ASCEND-2 Study Validating Its Investigational Multi-Cancer Early Detection Test at AACR Annual Meeting 2024

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, will present late-breaking data from the first analysis of the ASCEND-2 study demonstrating the compelling performance of its investigational multi-biomarker class, multi-cancer early detection (MCED) blood test. These results validate the sensitivity and specificity of the company’s multi-biomarker class approach across a broad range of cancer types, including the most aggressive cancers and cancers with no current standard of care for screening. ASCEND-2 is a large, multi-center, prospective, case-control study of over 11,000 clinically characterized participants from a racially, ethnically, and geographically diverse cohort representative of the U.S. population. These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, April 5-10 in San Diego, California.¹

“Cancer is the second-leading cause of death in the U.S., and while early detection is associated with longer survival, two-thirds of deaths are caused by cancers that lack standard screening tests. MCED tests have the potential to revolutionize cancer screening by enabling us to spot more cancers and intervene earlier,” said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences.^2-4 “This analysis from ASCEND-2 confirms that our multi-biomarker class approach to MCED test design may deliver benefits beyond what is currently achievable. The sensitivity and specificity achieved in the detection of the most aggressive cancers and those cancers with no current standard of care provide the confidence to move forward to a real-world evidence study.”

Exact Sciences will also present new outcomes data from DETECT-A, the first large prospective study of an earlier multi-biomarker class MCED test that enrolled more than 10,000 participants with more than four years of follow-up.⁵

The abstracts featured at AACR 2024 are as follows:

Title: Performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively collected cohort
Presenter: Diehl, F
Session: Monday, April 8, 9:00 a.m. – 12:30 p.m. PDT (Session LBPO.CL01)
Poster number: LB100/11
Location: Section 51
Key findings: First analysis of the refined multi-biomarker class MCED test achieved an overall sensitivity of 50.9% with 98.5% specificity and 56.8% sensitivity when breast and prostate cancer were excluded from the analysis. Sensitivity was 54.8% for cancers without standard-of-care screening for average-risk populations and 63.7% in the most aggressive cancers with the shortest 5-year survival rate (pancreas, esophagus, liver, lung and bronchus, stomach, and ovary).