Exact Sciences Corp., a leader in cancer diagnostics, has announced the launch of its groundbreaking Cancerguard test — a new multi-cancer early detection (MCED) blood test now available as a laboratory-developed test (LDT) in the United States.
This marks the first commercially available MCED test that evaluates multiple biomarker classes to detect a broad range of cancers, including those typically diagnosed only at advanced 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 complement existing screening tools and extend early detection to more cancer types. With a simple blood draw, it can detect signals from cancers responsible for over 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, Cancerguard can detect more than 50 cancer types and subtypes.
In test-development studies, the Cancerguard test demonstrated 68% sensitivity across six of the deadliest cancers and 64% sensitivity across a broader range of cancers (excluding breast and prostate). It also identified more than a third of stage I or II cancers, showing promise for early detection. Additionally, it achieved 97.4% specificity, minimizing false positives. Modeling shows that using this MCED technology alongside current screening methods could reduce stage IV cancer diagnoses by 42% and lower overall cancer mortality by 18%.
The Cancerguard test will be delivered through Exact Sciences’ extensive commercial network, engaging primary care physicians, oncologists, and major health systems. To support access, Exact Sciences has partnered with Quest Diagnostics to enable blood collection at its 7,000 patient access sites across the U.S., including patient service centers, in-office phlebotomists, and mobile at-home services.
“Cancerguard builds on the legacy of Cologuard, which has delivered more than 20 million test results and transformed colorectal cancer screening,” said Kevin Conroy, chairman and CEO of Exact Sciences. “Backed by strong science and developed to screen for many of the deadliest cancers, the Cancerguard test represents the next bold step in our mission to detect cancer earlier. With deep, trusted relationships across the health care system, Exact Sciences has the reach, credibility, and commitment to bring earlier answers to more people. This is the moment where we begin to change the course of cancer forever and give people power over their futures.”
Cancerguard is the result of nearly a decade of development and collaboration with leading academic institutions. It is supported by data from robust test-development studies such as DETECT-A and ASCEND 2, involving over 20,000 participants, including the first-ever prospective interventional MCED trial.
To further validate its clinical utility, Exact Sciences is enrolling up to 25,000 participants in the Falcon registry, a real-world evidence study conducted under a U.S. Food and Drug Administration (FDA)-reviewed Investigational Device Exemption (IDE). This evidence will support future regulatory submissions, payer coverage discussions, and efforts to include Cancerguard 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,” said Tom Beer, chief medical officer for multi-cancer early detection at Exact Sciences. “As adoption grows, we’ll look back and ask how we ever settled for screening for only a few cancers while letting the majority go undetected. Like the smartphone redefined communication, Cancerguard has the power to redefine cancer detection and the future of early intervention.”
Exact Sciences ensures the Cancerguard test fits into existing clinical workflows and electronic medical records (EMRs), with strong patient care navigation support, including help for patients with positive results.
The test is intended 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 and financial support options available — including a patient imaging assistance program to reduce non-covered imaging costs for eligible patients.