First clinical validation of the Oncodetect ^® test to be presented in triple negative breast cancer; signals highly sensitive molecular residual disease (MRD) detection

The Oncotype DX^® test is associated with improved outcomes and lower healthcare costs across all racial and ethnic groups, underscoring its value in promoting more equitable breast cancer care and narrowing disparities

Company Website: https://www.exactsciences.com
MADISON, Wis. -- (Business Wire)

Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, will present 10 abstracts across its Precision Oncology portfolio at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place from December 9-12 in San Antonio, Texas.

The data to be presented builds upon Exact Sciences’ long-standing commitment to backing innovation with strong clinical evidence and commitment to equitable breast cancer care. This commitment includes equipping clinicians with innovative solutions that provide actionable insights to support patient needs throughout every stage of cancer care.

“Oncotype DX has long set a global standard as a predictive and prognostic test in breast cancer, helping clinicians confidently guide therapy decisions that improve outcomes and reduce disparities,” said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. “The data presented at this year’s SABCS reaffirms our leadership in breast cancer prediction and prognosis and expands our evidence base for Oncodetect—our molecular residual disease test—as a powerful recurrence predictor and tool for personalizing surveillance in high-risk patients.”

Data presentations across Exact Sciences’ Precision Oncology portfolio include:

The Oncodetect Test^_®

Title: Evaluation of a Whole-Exome Sequencing Tumor-informed Circulating Tumor DNA MRD Assay in Patients with Early Triple-Negative Breast Cancer (TNBC) receiving Neoadjuvant Chemotherapy (NAC) with or without Atezolizumab: A Prospective Sub-study of the NSABP-B59/GBG-96-GeparDouze Trial

In partnership with the National Surgical Adjuvant Breast and Bowel Project (NSABP), this sub-study evaluated MRD in patients with triple-negative breast cancer (TNBC) and demonstrated the strong predictive performance of the Oncodetect test using prospectively collected samples from a Phase III randomized trial.

Session: RF4-03, Thursday, December 11, 2025; 4:30-5:30 PM

Title: Prospective Breast Cancer Clinical Validation Study of an Ultrasensitive, Tumor Informed, Whole Genome, Circulating Tumor DNA Assay to Detect Molecular Residual Disease and Predict Recurrence of High-Risk Early Breast Cancer Treated with Standard (Neo)adjuvant Therapy; NSABP B-64/EXActDNA-003NCT06401421

Conducted in collaboration with the NSABP, this large-scale, ongoing trial is enrolling more than 1,800 participants across all breast cancer subtypes. Tracking patients from diagnosis through treatment and post-therapy surveillance, the study will deliver multiple readouts beginning in 2027 that will further expand the clinical evidence supporting the Oncodetect test.

Session: PS5-08-21, Friday December 12, 2025; 12:30-2:00 PM

Title: Early Adoption of Molecular Residual Disease Testing in Breast Cancer Patients using Real World Data

This real-world data analysis of MRD adoption trends in breast cancer highlights the increasing use and integration of these tests into clinical practice.

Session: PS2-04-01, Thursday, December 11, 2025; 5:00-6:30 PM

The Oncotype DX Breast Recurrence Score^® Test

Title: Clinical and economic impact of the 21-gene assay for guiding treatment in patients with HR+/HER2- early breast cancer across racial and ethnic subgroups in the US

Study confirms that utilization of the Oncotype DX Breast Recurrence Score test to guide adjuvant therapy decision-making can lead to improved outcomes and reduce costs across diverse racial and ethnic subgroups, highlighting the potential of the assay to support more equitable care and reduce outcome disparities.

Session: PS4-09-24, Thursday, December 11, 2025; 5:00-6:30 PM

Title: Real-world utilization of the 21-gene assay for guiding treatment decisions in patients with HR+/HER2- early breast cancer in the US

Analysis demonstrates that the Oncotype DX Breast Recurrence Score test reliably guides adjuvant chemotherapy with utilization rising appropriately with higher scores and applied consistently across racial and ethnic groups, confirming equitable, guideline‑concordant treatment patterns highlighting the test’s impact in standardizing care decisions.

Session: PS2-06-21, Wednesday, December 10, 2025, 5:00-6:30 PM

Title: Real-world evidence on the use of a 21-gene recurrence score assay in patients with HR+/HER2− early breast cancer in Japan: a nationwide claims database analysis

First large-scale study of the Oncotype DX test in Japan confirmed that patients are treated at cancer-specialized or large medical centers and staging/treatment patterns show appropriate application of the Oncotype DX test in HR+/HER2 early breast cancer, consistent with current guidelines.

Session: PS3-08-28, Thursday, December 11, 2025; 12:30-2:00 PM

Title: Decision-Making on Adjuvant Chemotherapy in Early HR+ Breast Cancer: A Prospective Evaluation of Oncotype DX Utility Among Swiss Breast Cancer Experts

Study found that the Oncotype DX test significantly influenced adjuvant treatment decisions—primarily driving chemotherapy de‑escalation—and improved decision consistency among breast cancer specialists, underscoring the test’s utility in the Swiss healthcare system.

Session: PS3-10-10, Thursday, December 11, 2025; 12:30-2:00 PM

Title: The Societal Cost Impact of Oncotype DX Testing in an Irish Healthcare Setting

Use of the Oncotype DX test to identify node-positive patients that could avoid chemotherapy across 5 of Ireland’s oncology centers over an 11-year period has led to an estimated cost-savings of more than 60 million euros associated with chemotherapy use.

Session: PS3-09-03, Thursday, December 11, 2025; 12:30-2:00 PM

Title: Defining postpartum breast cancer based on 21-gene recurrence score

Breast cancer diagnosed within 5 years postpartum shows significantly higher Oncotype DX Recurrence Score results and higher histologic grade than in nulliparous peers—independent of nodal status. By stratifying risk by time since childbirth, the study refines the temporal definition of postpartum breast cancer and may inform risk stratification and treatment escalation.

Session: PosterPS3-07-11, Thursday, December 11; 2025; 12:30-2:00 PM

Title: Postpartum breast cancer as a potential driver of increased 21-gene recurrence score (RS) and RS category for node-positive HR+/HER2- breast cancer

In premenopausal, node-positive HR+/HER2− breast cancer, postpartum cases show higher Oncotype DX Recurrence Score results than nulliparous or non-postpartum cases. The study examines whether this impacts outcomes (e.g., invasive disease-free survival) to refine Recurrence Score result interpretation and better identify patients who might safely forgo chemotherapy, noting that larger studies with longer follow-up are needed.

Session: PS3-08-09, Thursday, December 11, 2025; 12:30-2:00 PM

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.

NOTE: Exact Sciences, Cologuard and Cancerguard are trademarks of Exact Sciences Corporation. Oncotype DX, Oncotype DX Breast Recurrence Score, Recurrence Score, and Oncodetect are registered trademarks of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation.

Forward-Looking Statement

This news release contains forward-looking statements concerning our expectations, intentions, and beliefs regarding future developments. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Details on these risks are included in the Risk Factors section of the company’s most recent filings with the Securities and Exchange Commission. Exact Sciences undertakes no obligation to update forward-looking statements due to new information or future events.

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Contacts:

Media Contact
Gisela Pedroza
+1 949-468-7854
gpedroza@exactsciences.com

Investor Contact
Derek Leckow
+1 608-893-0009
investorrelations@exactsciences.com

Source: Exact Sciences Corp.