Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer
Exact Sciences Corp. (NASDAQ:EXAS), a leading provider of cancer screening and diagnostic tests, today announced that its Oncodetect™ molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) for serial use in patients with stage II, III and resectable stage IV colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings over a five-year period. The final LCD can be found here, and the billing and coding article here, from CMS. This marks a significant milestone in the company's mission to transform cancer treatment through earlier detection and more personalized care.
Medicare coverage for colorectal cancer is a step forward to address the more than three million Americans eligible for MRD testing across multiple solid tumors.1 The highly sensitive, tumor-informed assay empowers oncologists and patients with insights during critical moments throughout treatment. The Oncodetect test tracks up to 200 ctDNA variants and can identify signs of cancer recurrence up to two years earlier than imaging alone.2
"Gaining Medicare coverage for the Oncodetect test is a meaningful step forward in expanding access to earlier, more personalized insights for patients with colorectal cancer," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "This decision underscores the clinical value of our MRD test and reinforces Exact Sciences' leadership in advancing tools that support timely, informed treatment decisions."
The Oncodetect test is supported by robust clinical validation studies, including Beta-CORRECT—Exact Sciences' largest MRD clinical study to date—which confirms the test's prognostic power across stages II-IV CRC3, and Alpha-CORRECT, one of the longest-followed MRD cohorts for CRC recurrence. Its integration with the ExactNexus™ technology platform enables seamless ordering alongside other Exact Sciences Precision Oncology solutions. Exact Sciences is pursuing additional Medicare coverage across other solid tumor indications, building on this momentum to bring the benefits of MRD testing to more patients.
For more information, visit www.oncodetect.com.
About the Oncodetect test
Developed by Exact Sciences, the Oncodetect test is a tumor-informed molecular residual disease (MRD) test designed to provide a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By leveraging the company's expertise in whole exome sequencing, the Oncodetect test analyzes circulating tumor DNA (ctDNA) shed into the bloodstream by tumors, offering critical insights into changes in ctDNA levels over time. This quantitative assessment of ctDNA (measured as MTM/mL) helps healthcare providers better understand a patient's MRD status and make informed treatment decisions4.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences (NASDAQ:EXAS) 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 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.
Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard and Exact Sciences are trademarks of Exact Sciences Corporation. Oncodetect is only available in the United States.
References
- Data source on file.
- Diergaarde B, Young G, Hall DW, Mazloom A, Costa G, Subramaniam S, Palomares M, Garces J, Baehner FL, Schoen RE; and other members of the Exact Sciences MRD Group. Circulating tumor DNA as a marker of recurrence risk in Stage III colorectal cancer: The α‐CORRECT study. Journal of Surgical Oncology.
- Hashimoto et. al: The Association of ctDNA with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT study. Presented at ASCO 2025.
- Internal product profile of the Oncodetect test.
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 Oncodetect test and the performance of the Oncodetect test in a commercial setting. 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.
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