New Cancerguard Blood Test for Multi-Cancer Early Detection Now Available in the US

Exact Sciences has announced the launch of Cancerguard™, a multi-cancer early detection (MCED) blood test now available as a laboratory-developed test in the United States. According to the company’s September 10, 2025, announcement, Cancerguard is the first commercially available MCED test to analyze multiple biomarker classes, designed to expand early cancer detection beyond currently recommended screening tests.1

Most cancers in the US are diagnosed at advanced stages, and nearly 70% of cancer cases and deaths occur in malignancies without existing screening options.2,3 Cancerguard aims to complement current population-based screening by detecting cancers responsible for more than 80% of annual diagnoses, including pancreatic, ovarian, liver, esophageal, lung, and stomach cancers. In development studies, the test demonstrated sensitivity of 68% across six of the deadliest cancers, 64% overall sensitivity across a broader group (excluding breast and prostate), and 97.4% specificity. Notably, it identified over one-third of stage I and II cancers, where treatment options are most effective.1

Modeling studies project that use of MCED technology alongside current screening could reduce stage IV cancer diagnoses by 42% and overall cancer mortality by 18% over 10 years. Cancerguard is priced at $689 and will be available nationwide through Quest Diagnostics’ approximately 7000 patient access sites, with additional in-office and at-home phlebotomy options.1

The test is supported by nearly a decade of development and validation in collaboration with academic partners. Key studies include DETECT-A and ASCEND-2, involving more than 20 000 participants, including the first prospective interventional MCED trial. Exact Sciences is also conducting the Falcon registry, enrolling up to 25 000 participants under a US FDA-reviewed Investigational Device Exemption to evaluate real-world utility and support regulatory submissions.

Cancerguard is intended for adults aged 50–84 years without a known cancer diagnosis in the past 3 years and can be ordered annually. Results integrate into electronic medical records and are supported by care navigation services for both clinicians and patients. For individuals with positive test results, Exact Sciences provides imaging assistance programs to reduce the cost of follow-up diagnostics not covered by insurance.

Kevin Conroy, chairman and CEO of Exact Sciences, stated that Cancerguard “represents the next bold step in our mission to detect cancer earlier.” Tom Beer, MD, chief medical officer for multi-cancer early detection at Exact Sciences, added that the test “offers a critical early warning that cancer may be present and helps inform an imaging-guided pathway to diagnosis.”

References:

1. Exact Sciences. Exact Sciences launches Cancerguard™, first-of-its-kind multi-cancer early detection blood test. News release. September 10, 2025. Accessed September 10, 2025. https://www.exactsciences.com/news-events/press-releases/exact-sciences-launches-cancerguard-first-of-its-kind-multi-cancer-early-detection-blood-test
2. Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75:10-45.
3. United States Preventive Services Task Force. A and B recommendations. Published 2022. Accessed September 10, 2025. https://uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-and-b-recommendations