Exact Sciences Corp. has launched Cancerguard, a groundbreaking multi-cancer early detection (MCED) blood test that represents the first commercially available test of its kind to analyze multiple biomarker classes for cancer detection. The Madison-based company, known for its Cologuard colorectal cancer screening test, announced the launch after nearly a decade of research and development.
The Cancerguard test addresses a significant unmet medical need, targeting the nearly 70% of annual cancer cases and deaths in the U.S. that occur in cancers with no recommended screening protocols. The 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.
Clinical Performance and Validation
In test-development studies, Cancerguard demonstrated robust clinical performance with 68% sensitivity across six of the deadliest cancers and 64% overall sensitivity across a broader range of cancers, excluding breast and prostate. The test achieved high specificity of 97.4%, helping to minimize false positives and avoid unnecessary procedures.
Notably, the test found more than a third of stage I or II cancers, demonstrating its ability to detect disease when it's most treatable. Modeling studies suggest 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%.
The test's development is backed by rigorous science conducted in partnership with top academic institutions. It is supported by data from robust test-development studies, including DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial.
Commercial Availability and Access
The Cancerguard test is priced at $689 and is recommended for individuals aged 50-84 with no known cancer diagnosis in the past three years for annual screening. Currently available as a laboratory-developed test (LDT), patients must pay out of pocket, though the test may be eligible for flexible spending and health savings account use.
To support nationwide access, Exact Sciences has entered into an agreement with Quest Diagnostics to enable blood collection at approximately 7,000 patient access sites across the U.S. These sites include patient service centers, in-office phlebotomists in provider offices, and mobile phlebotomy services for at-home collections.
"This is the moment where we begin to change the course of cancer forever and give people power over their futures," said Kevin Conroy, Exact Sciences' chairman and CEO. "The Cancerguard test represents the next bold step in our mission to detect cancer earlier."
Future Development and Regulatory Path
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.
Dr. Tom Beer, chief medical officer for multi-cancer early detection at Exact Sciences, emphasized the test's potential impact: "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."
The company plans to work with insurance companies to secure coverage for the test, with the hope that payers throughout the country will eventually cover Cancerguard based on the extensive clinical data supporting its use.
Company Background and Market Position
Exact Sciences, founded in 1995 and publicly traded since 2001, employs more than 7,000 people across the country, including about 3,000 in Dane County, Wisconsin. The company has established itself as a pillar of the Madison-area biotech industry with headquarters in the UW Research Park and major facilities throughout the region.
The launch of Cancerguard represents a significant evolution for the company beyond its successful Cologuard platform, which has delivered more than 20 million test results and transformed colorectal cancer screening. Last month, Exact Sciences reported 16% revenue growth over the previous year and expects to bring in $3.1 billion in revenue for the year.
