On Sept. 10, 2025, Exact Sciences 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.

Nearly 70 percent of annual cancer cases and deaths in the U.S. occur in cancers with no recommended screening. The Cancerguard test can help address the unmet need by complementing existing routine screening and extending the reach of early detection. With a simple blood draw, the Cancerguard test can detect signals from cancer types responsible for more than 80 percent of annual U.S. cancer diagnoses, including some with the highest mortality rates, such as pancreatic, ovarian, liver, esophageal, lung, and stomach cancers. Overall, the Cancerguard test can detect more than 50 cancer types and subtypes.

The Cancerguard test delivered 68 percent sensitivity across six of the deadliest cancers and 64 percent overall sensitivity across a broader range of cancers, excluding breast and prostate, in test-development studies. It also found more than a third of stage I or II cancers, demonstrating its ability to detect disease when it’s most treatable.

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.⁶ 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.