On December 11, Exact Sciences presented the first clinical study results for its Oncodetect® molecular residual disease (MRD) test in early triple‑negative breast cancer (TNBC) at the San Antonio Breast Cancer Symposium (SABCS). The substudy, comprising 147 patients from the NSABP B‑59 trial, was conducted in partnership with the NSABP Foundation and the German Breast Group.
The data show that patients who remained ctDNA‑positive after neoadjuvant therapy and surgery faced a substantially higher risk of distant recurrence than ctDNA‑negative patients. This strong prognostic signal demonstrates the test’s potential to guide post‑surgical treatment decisions for a subtype of breast cancer that lacks targeted therapies.
Exact Sciences plans to submit the data to MolDx to support Medicare coverage, a critical step toward payer reimbursement and broader clinical adoption. Securing coverage would validate the test’s clinical utility and open a significant U.S. market for the company’s precision‑oncology portfolio.
The Oncodetect MRD test expands Exact Sciences’ precision‑oncology offerings beyond its established screening products such as Cologuard and Oncotype DX. The company’s Q4 2023 revenue of $647 million, driven by strong demand in both screening and precision oncology segments, set the stage for continued growth. Q3 2024 revenue rose to $709 million, and Q4 2024 revenue reached $713 million, reflecting steady momentum in the company’s core businesses.
While the article does not report immediate market reaction, the company’s strong performance and strategic progress have reinforced investor confidence, as evidenced by the company’s continued upward trajectory in its long‑term outlook.
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