Exact Sciences today announced the launch of the Cancerguard test, a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States.
Cancerguard is the first MCED test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.
Additionally, the test achieved high specificity of 97.4 percent, helping to minimize false positives and avoid unnecessary procedures. Modeling shows that over a 10-year period, use of Exact Sciences’ MCED technology alongside current screening methods could reduce stage IV cancer diagnoses by 42 percent and lower overall cancer-related mortality by 18 percent. Together, these findings underscore the Cancerguard test’s potential to meaningfully improve outcomes and elevate the standard of cancer detection.
The Cancerguard test will be delivered through Exact Sciences’ expansive commercial and operational infrastructure, including a national sales force that engages primary care physicians, oncologists, and leading health systems. To support patient access, Exact Sciences has entered into an agreement with Quest Diagnostics to enable blood collection at the company’s approximately 7,000 patient access sites across the U.S., including through its patient service centers and in-office phlebotomists in provider offices, as well as mobile phlebotomy services for at-home collections.
The Cancerguard test is the culmination of nearly a decade of development and is backed by rigorous science in partnership with top academic institutions. The test is supported by data from robust test-development studies, such as DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial. To further validate clinical utility and support broad adoption, Exact Sciences is actively enrolling up to 25,000 participants in the Falcon registry, a real-world evidence study conducted under a U.S. FDA-reviewed Investigational Device Exemption (IDE). This comprehensive body of evidence is designed to inform future regulatory submissions, support payer discussions on coverage and reimbursement, and guide efforts to include the Cancerguard test in clinical guidelines.
The Cancerguard test is recommended for individuals aged 50-84 with no known cancer diagnosis in the past three years and can be considered annually. It is priced at $689 and may be eligible for flexible spending and health savings account use, with payment plans available.
