Multi-Cancer Early Detection Test Shows Promise in Detecting Deadly Cancers

Strategic Insights -

A groundbreaking study involving the Exact Sciences' Falcon Registry Real-World Evidence (RWE) program is enrolling over 1,000 patients to test the effectiveness of a simple blood draw in detecting over 50 types and subtypes of cancer, including those without routine screening guidelines. The Cancerguard MCED test uses DNA methylation and protein biomarkers to identify cancer signals associated with various cancer types. As the second-leading cause of death worldwide, accounting for 10 million deaths in 2021, the need for more screening options is imperative, especially for cancers with no proven screening strategy.

Key Takeaways:

  • The Cancerguard MCED test can detect signals from cancer types responsible for more than 80% of annual U.S. diagnoses, including lethal types such as pancreatic, ovarian, liver, esophageal, lung, and stomach cancers.
  • The study will create a registry that tracks patient data over time, enabling researchers to evaluate outcomes and guide improvements in future strategies for cancer screening and treatment.
  • Patients will undergo MCED testing annually for three years, followed by two additional years of ongoing data collection.
  • The registry will allow researchers to study the effectiveness and pathways to better use MCED tests in clinical care.
  • The primary goal of the study is to empower patients with knowledge and tools to proactively manage their health.
  • The study aims to enroll up to 25,000 participants over a five-year period across diverse communities.
  • The study sites serve a broad range of communities to provide insights on the potential benefits of early detection across varied populations.
  • The study will help determine how MCED testing can best be integrated into routine care to improve early detection rates and ultimately lead to better outcomes for patients.

Statistics:

  • Over 1,000 patients have been enrolled in the study.
  • The test can detect signals from cancer types responsible for more than 80% of annual U.S. diagnoses.
  • Cancer remains the second-leading cause of death worldwide, accounting for an estimated 10 million deaths in 2021.
  • The study will track patient data over time for a period of five years.
  • The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration.

Sources:

  • News Release: Endeavor Health (Oct. 30) (exact format from original)
  • Cancerguard Clinician Brochure. Exact Sciences Corporation.
  • Siegel RL, Kratzer TB, Giaquinto AN, et al. Cancer statistics, 2025. CA Cancer J Clin. 2025;75:10-45.
  • Data on file. Calculated ASCEND-2 Cancer Detection and Associated Cancer Burden. 2025. Medical Affairs, Exact Sciences, Madison, WI.
  • United States Preventive Services Task Force. A and B recommendations. Published 2022. Accessed October 16, 2025. https://uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-and-b-recommendations