Exact Sciences Launches the Oncodetect™ Molecular Residual Disease Test

The new, highly sensitive, tumor-informed test detects up to 200 ctDNA* variants, identifying signs of colorectal cancer (CRC) recurrence up to two years earlier than imaging—making it one of the most comprehensive MRD tests available^1,2

The Oncodetect test is available for order across multiple solid tumors^†

Exact Sciences Corp. (NASDAQ:EXAS), a leading provider of cancer screening and diagnostic tests, today announced the launch of Oncodetect™—a new test designed to detect molecular residual disease (MRD) across multiple solid tumors. The Oncodetect test provides patients and their healthcare providers with the insights needed to make more informed decisions throughout the treatment process, advancing the field of MRD testing.

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The Oncodetect test delivers clear "Detected" or "Not Detected" results, accompanied by quantitative data to help support adjuvant therapy decisions, evaluate treatment response, and monitor cancer recurrence. Notably, patients who test positive for ctDNA with the Oncodetect test during surveillance are 50 times more likely to experience cancer recurrence than those with negative results¹. Highly sensitive and personalized, the test tracks up to 200 tumor-specific variants and identifies even trace amounts of ctDNA—down to 1 ctDNA molecule in 20,000 cfDNA^‡ molecules. This sensitivity enables earlier detection of CRC recurrence compared to imaging alone^1,2.

"Exact Sciences is transforming cancer care by delivering tests that provide the clarity patients and physicians need to make confident decisions," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "After surgery and definitive therapy, such as chemotherapy or radiation, the risk for cancer recurrence remains a major concern. Advanced detection tools like the Oncodetect test help bridge that gap by providing clinical insights at critical periods, leading to more informed treatment decisions and personalized care."

Backed by robust clinical validation, including data from the Alpha-CORRECT study—one of the longest-followed MRD cohorts for CRC recurrence with nearly five years of follow-up—the Oncodetect test enhances understanding of cancer recurrence and helps support timely, personalized treatment decisions. Exact Sciences is actively working with Medicare to secure reimbursement for the test, ensuring broad patient access nationwide. The company is also advancing clinical and analytical validation studies across multiple solid tumors, supported by strategic partnerships for multi-cancer evidence generation.

"Exact Sciences is a longtime trusted partner in addressing the critical unmet needs in colorectal cancer care, ensuring patients have the insights they need to navigate treatment with confidence," said Vanessa Ghigliotty, Certified Patient Navigator & Chair, Patient Advisory Board, GI Cancers Alliance^§. "For those facing the uncertainty of recurrence, tumor-informed MRD tests like the Oncodetect test can provide clear, timely answers—empowering patients to take an active role in their care and receive the right treatment at the right time for better outcomes."

The Oncodetect test builds on 20 years of genomic testing excellence established by the Oncotype DX Breast Recurrence Score^® test. Integrated into a world-class digital experience, supported by the ExactNexus™ technology platform, the Oncodetect test can be ordered with other Exact Sciences tests, including OncoExTra^® (comprehensive genomic profiling) and Riskguard® (hereditary cancer testing). With more than 3 million American patients³ eligible for MRD testing, Exact Sciences is well-positioned to shape the future of personalized care.

The Oncodetect test is now available. For more information, visit www.oncodetect.com

* Circulating tumor DNA

† The Oncodetect test was clinically validated in colorectal cancer patients with stage II-IV disease. Performance characteristics may not apply in tumor types not included in this test's clinical validation.

‡ Cell-free DNA

§ Ghigliotty attended the March 2025 Cologuard Classic through a grant from Exact Sciences to the GI Cancers Alliance, which has also received prior funding from the company.

References

1. 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.
2. Santonja et al 2023 EMBO (https://www.embopress.org/doi/full/10.15252/emmm.202216505)
3. Data source on file
4. Internal product profile of the Oncodetect test
   
   

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 decisions ⁴.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

Oncodetect, Oncotype, Oncotype DX Breast Recurrence Score, and OncoExTra are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Riskguard are trademarks of Exact Sciences Corporation. Oncodetect, Cologuard, Riskguard, and OncoExTra are only available in the United States.

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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