Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect® MRD Test in Early Triple-Negative Breast Cancer at SABCS

Key Terms

molecular residual disease medical

Molecular residual disease is the tiny amount of cancer that can remain in the body after treatment and is detectable only by sensitive tests that find cancer DNA or other molecular traces. It matters to investors because these measurements can predict relapse, guide whether additional therapy is needed, and shape the market for diagnostics and drugs—much like finding embers after a fire helps decide if more firefighting is required.

triple-negative breast cancer medical

Triple-negative breast cancer is a type of breast cancer that lacks three common markers used to identify and treat the disease effectively. Because it doesn’t respond to some targeted therapies, it can be more difficult to treat and may have a more aggressive progression. This impacts the development of new treatments and can influence the outlook for healthcare companies involved in cancer research and pharmaceuticals.

circulating tumor DNA medical

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

adjuvant therapy medical

Adjuvant therapy is an extra medical treatment given after the main treatment—often surgery—to reduce the chance that a disease will come back, such as additional drugs, radiation, or immune-based treatments. For investors it matters because successful adjuvant treatments can expand the market for a drug, influence regulatory approval and reimbursement, and change revenue forecasts much like a protective follow-up step that prevents problems from reappearing.

distant recurrence-free interval medical

Distant recurrence-free interval is the length of time after initial cancer treatment during which the disease does not come back in a different part of the body (metastasis). For investors, it’s a key measure of a therapy’s ability to delay or prevent serious relapse—longer intervals suggest stronger clinical benefit, which can improve a drug’s regulatory prospects, adoption by doctors, and commercial value. Think of it like the warranty period before a major problem reappears.

whole-exome sequencing medical

Whole-exome sequencing is a laboratory method that reads the portions of an individual’s DNA that directly code for proteins (the exome), which is a small but information-rich slice of the genome. For investors it matters because it’s a faster, cheaper way to find genetic changes linked to disease, guiding diagnostic tests, drug targets and personalized treatments—similar to scanning the most relevant pages of a large manual to find where errors occur.

New data reveals Oncodetect’s powerful prognostic performance in one of the largest TNBC MRD studies to date¹

MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the first clinical study results from its Oncodetect^® molecular residual disease (MRD) test in breast cancer. Findings from the NSABP B-59 substudy, conducted in collaboration with the NSABP Foundation and the German Breast Group (GBG), demonstrated that the Oncodetect test strongly predicts distant recurrence following surgery in patients with early triple-negative breast cancer (TNBC)², one of the most aggressive and difficult-to-treat breast cancer subtypes.³

These data, representing one of the largest TNBC MRD datasets analyzed to date,¹ were presented by Dr. Marija Balic, MD, PhD, scientific director of the NSABP Translational Research Program, at the San Antonio Breast Cancer Symposium (SABCS). The results demonstrate Oncodetect’s ability to help identify patients at higher risk of recurrence and strengthen the growing clinical evidence supporting the test’s role in guiding post-surgical treatment decisions.

The entities intend to submit these data to a peer-reviewed journal for publication, and Exact Sciences will submit the data to MolDx in support of Medicare coverage.

Prognostic performance of the Oncodetect test in early triple-negative breast cancer

In an analysis of 147 patients from the B-59 substudy, post-surgical detection of circulating tumor DNA (ctDNA) was strongly associated with risk of distant recurrence.² Patients who remained ctDNA-positive after neoadjuvant therapy and surgery had substantially higher recurrence risk compared to ctDNA-negative patients.² The key findings include:

• Post-surgery MRD-positive status was associated with a ~30-fold higher risk of distant recurrence compared to those who were MRD-negative.²
• 95% of patients who were MRD negative after surgery remained free of distant recurrence at 3 years.²
• Neo-adjuvant therapy given before surgical resection, which is the standard of care in patients with TNBC, reduced ctDNA positivity in patients from 95% before the start of treatment to 9% after treatment. ²

These data demonstrate that ctDNA detection after surgery is a powerful prognostic indicator of recurrence risk in TNBC and may help identify patients who could benefit from additional adjuvant therapy.

“The NSABP Foundation is proud to collaborate on this impactful study,” said Dr. Norman Wolmark, chairman, NSABP Foundation. “The strength of these data, particularly the clear separation in distant recurrence curves, highlight the prognostic power of ctDNA and its potential to guide post-surgical management strategies for high-risk breast cancer.”

Inside the NSABP B-59 study

In partnership with the NSABP Foundation, the Oncodetect substudy was conducted within the NSABP-B-59/GBG-96-GeparDouze trial, which enrolled patients with TNBC receiving neoadjuvant therapy with or without atezolizumab. Blood samples were collected before treatment and after surgery to evaluate whether ctDNA positivity at the post-surgery timepoint was associated with distant recurrence-free interval, with a median follow-up of 37 months. Exact Sciences is also collaborating with the NSABP Foundation on NSABP B-64, a large prospective registry trial enrolling 1,800 participants across all breast cancer subtypes.

“This is an important milestone for our Oncodetect program and for patients facing aggressive breast cancers like TNBC,” said Dr. Rick Baehner, senior vice president, chief medical officer, Precision Oncology at Exact Sciences. “These data demonstrate how ctDNA testing can provide critical insights into recurrence risk and more precisely help inform treatment decisions.”

References

1. Data source on file. Accessed November 25, 2025.
2. Balic, Marija, Geyer, Charles Jr. et. al. Evaluation of a whole-exome sequencing tumor-informed circulating tumor DNA MRD assay in patients with early triple-negative breast cancer receiving neoadjuvant chemotherapy with or without atezolizumab: A substudy of the NSABP-B-59/GBG-96-GeparDouze Trial. Presented at: San Antonio Breast Cancer Symposium (SABCS): December 11, 2025; San Antonio, TX.
3. Obidiro O, Battogtokh G, Akala EO. Triple Negative Breast Cancer Treatment Options and Limitations: Future Outlook. Pharmaceutics. 2023 Jun 23;15(7):1796. doi: 10.3390/pharmaceutics15071796. PMID: 37513983; PMCID: PMC10384267.

About Exact Sciences

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 the Cancerguard^® test for multi-cancer early detection and the Oncodetect^® test 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.

About NSABP Foundation

The NSABP Foundation designs and conducts clinical trials to improve the care of people with breast or colorectal cancer. The Foundation manages more than 700 sites that enroll patients into clinical trials. Founded in 1958 as the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), the goal is to identify and achieve opportunities for enhanced diagnostics, more precise and less debilitating treatments, and develop clinical strategies for the prevention of cancer for those who are at risk. To learn more and to support the mission, please visit www.NSABP.org.

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. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251211912129/en/

Media Contact

Lisa Warshaw

+1 323-360-8778

lwarshaw@exactsciences.com

Investor Contact

Derek Leckow

+1 608-893-0009

investorrelations@exactsciences.com

Source: Exact Sciences Corp.