お知らせ • Sep 10
Exact Sciences Corp. Launches Cancerguard™, First-Of-Its-Kind Multi-Cancer Early Detection Blood Test
Exact Sciences Corp. 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. The Cancerguard test kit: 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 detection more than 50 cancer types and subtypes. The Cancerguard test delivered 68% sensitivity across six of the deadliest cancers and 64% 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. 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%. Together, these findings underscore the Cancerguard test's potential to meaningfully improve outcomes and elevate the standard of cancer detection. 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.7,8,9 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 (IDE10). 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 offers a critical early warning that cancer may be present and helps inform an imaging-guided pathway to diagnosis, giving people the chance to act when it matters most.