Exact Sciences launches Cancerguard test in the U.S.

Exact Sciences (EXAS) announced the launch of the Cancerguard test, a new multi-cancer early detection, or MCED, blood test that is now available as a laboratory-developed test, or LDT, in the U.S.. 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% 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% 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.5 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%, helping to minimize false positives and avoid unnecessary procedures.4 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% 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.