Policy & Regulation
JAMA oncology review validates Exact Sciences Corp's Oncotype DX test accuracy across racial and ethnic groups
14 April 2025 -

Cancer screening and diagnostic tests provider Exact Sciences Corp (Nasdaq: EXAS) announced on Monday that newly published review in JAMA Oncology confirms the reliability of the company's Oncotype DX Breast Recurrence Score test in predicting breast cancer outcomes and chemotherapy benefit across all racial and ethnic populations.

Titled Genomic Assays for Breast Cancer in Diverse Populations: Prognostic and Predictive Insights, the peer-reviewed article reinforces the test's role in supporting personalised treatment decisions irrespective of demographic differences. This adds to mounting evidence that the test delivers consistent predictive value, even amid ongoing disparities in breast cancer mortality - particularly among non-Hispanic Black women, who face a 40% higher death rate compared to non-Hispanic White women.

New real-world data from over 171,000 patients in the SEER registry, presented at ASCO 2024, further validate Oncotype DX's predictive accuracy across Hispanic, non-Hispanic Black, and non-Hispanic White populations. These findings complement earlier evidence from key trials including NSABP-B20, SWOG-8814, TAILORx, and RxPONDER, which collectively establish Oncotype DX as the only genomic test clinically proven to predict chemotherapy benefit.

While the test helps guide equitable clinical decision-making, the publication calls for continued research into the underlying biological, social and systemic causes of outcome disparities in breast cancer care.

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