Exact Sciences Applauds Passage of Legislation Establishing Medicare Coverage Pathway for Multi-Cancer Early Detection Tests
Passage of MCED legislation marks major milestone for early cancer detection
Exact Sciences Corp. (NASDAQ:EXAS), a leading provider of cancer screening and diagnostic tests, today celebrated the passage of landmark federal legislation that establishes a pathway to enable Medicare coverage for multi-cancer early detection (MCED) tests. Nearly 70% of annual cancer cases and deaths in the U.S. occur in cancers with no recommended screening,1,2 and cancer remains the second leading cause of death in the U.S.1 By aligning public policy with scientific innovation and patient need, this legislation represents a critical step toward addressing that unmet need and expanding access to this emerging technology for millions of Medicare beneficiaries.
Based on the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, the legislation establishes a clear coverage framework for MCED tests following U.S. Food and Drug Administration (FDA) approval and subsequent Centers for Medicare & Medicaid Services (CMS) implementation. The legislation is backed by overwhelming bipartisan support, reflecting growing recognition of the urgent need to detect more cancers earlier.
"It's a historic day in the fight against cancer. We are deeply grateful to lawmakers, especially Representatives Terri Sewell (D-AL) and Jodey Arrington (R-TX), patient advocates, and all those who fought tirelessly for this groundbreaking legislation," said Kevin Conroy, chairman and CEO of Exact Sciences. "Most importantly, we are thrilled for the countless individuals whose lives will be impacted by these tests, potentially giving them more opportunities to celebrate birthdays, anniversaries, and precious moments with their loved ones."
Building on decades of scientific research, Exact Sciences' Cancerguard® test is designed to detect signals associated with a wide range of cancers from a simple blood draw, with the goal of identifying disease at earlier, more treatable stages. The test remains under continued clinical evaluation and is intended to complement — not replace — guideline-recommended cancer screenings. The Cancerguard test can help detect cancer types that often go undetected and account for a significant share of annual diagnoses in the U.S.1 Modelling suggests Exact Sciences' MCED technology has the potential to slash stage IV cancer diagnoses by 45% when added to standard-of-care screening.3
About the Cancerguard® test
Cancerguard® is a laboratory-developed test (LDT) from Exact Sciences designed to detect multiple cancers, including the most aggressive cancers, in early stages from a simple blood draw. It integrates two classes of biomarkers to enable broader detection and follows a streamlined, imaging-based diagnostic pathway to help reduce unnecessary follow-up procedures. Developed with high specificity to minimize false positives, the test targets a wide range of cancers, including those that lack guideline-recommended screening options. The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. To learn more, visit http://www.exactsciences.com.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company's growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like Cancerguard® for blood-based analysis of molecular information across multiple cancers and Oncodetect® for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.
NOTE: Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cancerguard, Cologuard and Exact Sciences are trademarks of Exact Sciences Corporation. Cologuard, Cancerguard and Oncodetect are currently only available in the U.S.
Forward-Looking Statement
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding our expectations for the commercialization of the Cancerguard test, the performance characteristics and health care benefits of the Cancerguard test in a commercial setting, and the potential for guidelines inclusion and insurance reimbursement. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
1 Siegel RL, Kratzer TB, Wagle NS, Sung H, Jemal A. Cancer statistics, 2026. CA Cancer J Clin. 2026;e70043. doi:10.3322/caac.70043
2 United States Preventive Services Task Force. A and B recommendations. Published 2022. Accessed January 20, 2026. https://uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-and-b-recommendations.
3 Chhatwal J, Xiao J, ElHabr AK, Tyson C, Cao X, Raoof S, Fendrick AM, Ozbay AB, Limburg P, Beer TM, Briggs A, Deshmukh AA. The impact of multicancer early detection tests on cancer stage shift: A 10-year microsimulation model. Cancer. 2025 Nov 15;131(22):e70075. doi: 10.1002/cncr.70075. PMID: 41208393; PMCID: PMC12598375.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260203507378/en/
Media Contact: Lauren Vitanye, [email protected], 608-640-6723
Investor Contact: Derek Leckow, [email protected], 608-893-0009