JAMA Oncology Publication Strengthens Evidence for Oncotype DX® Test Reliability Across Racial and Ethnic Groups

By: Exact Sciences Corp. via Business Wire

April 14, 2025 at 06:00 AM EDT

Comprehensive review confirms that the Oncotype DX Breast Recurrence Score^® test accurately predicts breast cancer outcomes and chemotherapy benefit for patients regardless of race or ethnicity

Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the publication of a comprehensive review in JAMA Oncology that strengthens the evidence supporting the Oncotype DX Breast Recurrence Score test. The peer-reviewed article titled, “Genomic Assays for Breast Cancer in Diverse Populations: Prognostic and Predictive Insights,” affirms that the Oncotype DX test provides accurate and reliable information to help guide breast cancer treatment decisions across all racial and ethnic groups.

While breast cancer mortality has declined overall, non-Hispanic Black women continue to face a 40% higher mortality rate compared to non-Hispanic White women^I. The publication acknowledges these disparities and the need to better understand the complex factors behind them. Despite the prognostic differences between racial and ethnic minority groups, the Oncoytpe DX Breast Recurrence Score test accurately predicts chemotherapy benefit regardless of race or ethnicity. While these disparities highlight the need for broader systemic change, advancing precision oncology remains critical and tools like the Oncotype DX Breast Recurrence Score test ensure treatment decisions are guided by reliable data for every patient.

The largest real-world SEER registry analysis to date—spanning more than 171,000 breast cancer patients and presented at ASCO 2024—provides powerful new evidence that the Oncotype DX test accurately predicts chemotherapy benefit across all racial and ethnic groups. In this study, which is not part of the JAMA Oncology review, the Recurrence Score^® result predicted chemotherapy benefit in Hispanic, non-Hispanic Black and non-Hispanic White patients^II. These findings add to the body of evidence from key clinical trials—including NSABP^*-B20 and SWOG^†-8814—which confirm that Oncotype DX is the only genomic test proven to predict chemotherapy benefit, the utility of which was further confirmed in randomized clinical trials including TAILORx and RxPONDER^III,IV. With no racial or ethnic differences shown in its predictive value, the Oncotype DX test remains a trusted tool to help guide breast cancer treatment decisions for all patients.

“This study helps deepen our understanding of the multifaceted factors driving disparities in breast cancer outcomes,” said Dr. Yara Abdou, assistant professor of medicine and breast cancer clinical trial program leader at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill and the first author of the paper. “By building on insights from landmark clinical trials, we further validate the utility of genomic tests across diverse populations. Our findings reinforce the value of using genomic assays to help guide treatment decisions for all racial and ethnic groups.”

Key Highlights:

This publication reinforces the Oncotype DX test’s value in helping guide treatment decisions—providing precise estimates of distant recurrence risk and accurately identifying which breast cancer patients may or may not benefit from chemotherapy, regardless of race or ethnicity.
Secondary analyses of TAILORx and RxPONDER, which included the Oncotype DX Breast Recurrence Score test, confirm consistent chemotherapy benefit across racial and ethnic groups,highlighting that worse prognostic outcomes do not necessarily translate to greater chemotherapy benefit^V.
The paper suggests that continued research is essential to understanding the biological, social, and systemic drivers of disparities in breast cancer outcomes—and to ensuring equitable access to genomic tools like the Oncotype DX test.

“At Exact Sciences, we’re proud that the Oncotype DX test continues to stand alone as the only genomic test validated to predict chemotherapy benefit in randomized trials—and that it performs consistently across racial and ethnic groups^V,” said Dr. Rick Baehner, chief medical officer of Precision Oncology at Exact Sciences. “We remain deeply committed to partnering with global clinical leaders to reduce disparities and ensure every patient has access to the Oncotype DX test.”

* National Surgical Adjuvant Breast and Bowel Project

† SWOG is part of the National Cancer Institute’s National Clinical Trials Network

References

	I.	Giaquinto AN, Sung H, Miller KD, et al. Breast Cancer Statistics, 2022. CA Cancer J Clin. Nov 2022;72(6):524-541. doi:10.3322/caac.21754
	II.	Diego et al. Updated SEER database study of 21-gene assay to assess breast cancer-specific mortality and benefit of chemotherapy by race and ethnicity. Presented at ASCO 2024.
	III.	Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 455. Jun 3 2018;379(2):111-121. doi:10.1056/NEJMoa1804710
	IV.	Kalinsky K, Barlow WE, Gralow JR, et al. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 461. Dec 16 2021;385(25):2336-2347. doi:10.1056/NEJMoa2108873
	V.	Abdou Y, Kantor O, Racz J, Newman L, Pierce LJ, Winer EP. Prognostic and Predictive Insights From Genomic Assays for Breast Cancer in Diverse Populations: A Review. JAMA Oncol. Published online April 03, 2025. doi:10.1001/jamaoncol.2025.0178

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype DX^® 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.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20250414083475/en/

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Lisa Warshaw

lwarshaw@exactsciences.com

Media (OUS)

Federico Maiardi

+41 79-138-1326

fmaiardi@exactsciences.com

Investors

Derek Leckow

+1 608-893-0009

investorrelations@exactsciences.com

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JAMA Oncology Publication Strengthens Evidence for Oncotype DX® Test Reliability Across Racial and Ethnic Groups

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