Exact Sciences Applauds Passage of Legislation Establishing Medicare Coverage Pathway for Multi-Cancer Early Detection Tests

Key Terms

multi-cancer early detection medical

A multi-cancer early detection test is a medical screening tool—often a simple blood test—that looks for biological signals, such as abnormal DNA or protein patterns, that could indicate many different cancers before symptoms appear. For investors it matters because successful tests can reshape demand for diagnostics, influence healthcare spending and insurance coverage, and create new revenue streams or risks for companies across diagnostics, treatment and screening services; think of it as a smoke alarm that can warn of problems throughout an entire house rather than just one room.

MCED medical

A multi-cancer early detection (MCED) test is a blood-based screening tool designed to detect signs of many different cancers from a single sample, often before symptoms appear. For investors, MCEDs matter because they represent a potential shift from disease-by-disease screening to a one-stop early-warning test, which could unlock large markets, change clinical practice, and carry regulatory, reimbursement and adoption risks similar to other breakthrough medical technologies; think of it as a smoke alarm that tries to spot many types of fires early.

u.s. food and drug administration regulatory

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

FDA regulatory

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

centers for medicare & medicaid services regulatory

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

CMS regulatory

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that sets rules, payment rates and coverage decisions for major public health insurance programs; think of it as both a giant insurer and the rulebook maker for how many healthcare providers and drug makers get paid by government programs. Its policy changes and reimbursement decisions can materially affect revenue, profit forecasts and valuations for hospitals, insurers, device makers and drug companies, so investors watch CMS announcements closely.

medicare regulatory

Medicare is a large government-run health insurance program that primarily covers people aged 65 and older and certain younger people with disabilities. For investors it matters because Medicare acts like a huge customer and rule-maker for hospitals, drugmakers and medical-device companies—its coverage decisions, payment rates and regulatory policies can change demand, revenue and profit margins across the healthcare sector, similar to how a major client or regulator can shape a business’s prospects.

Passage of MCED legislation marks major milestone for early cancer detection

MADISON, Wis.--(BUSINESS WIRE)-- 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, lvitanye@exactsciences.com, 608-640-6723

Investor Contact: Derek Leckow, investorrelations@exactsciences.com, 608-893-0009

Source: Exact Sciences Corp.