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Exact Sciences Partners With West German Study Group to Validate MRD Test in Breast Cancer

NEW YORK – Exact Sciences said Wednesday that it will collaborate with the West German Study Group (WSG) to evaluate whether Exact's circulating tumor DNA liquid biopsy test can detect minimal residual disease in hormone receptor-positive, HER2-negative early-stage breast cancer patients.

The collaborators will gather data from 3,000 German patients enrolled in three ongoing studies sponsored by the WSG, in which they have received Exact's Oncotype DX breast cancer recurrence test. The aim of the analysis, dubbed ADAPT Triad, is to generate evidence on the ability of the tumor-informed ctDNA MRD test to inform treatment decisions and help monitor recurrence of HR-positive, HER2-negative early-stage breast cancer.

The researchers will track breast cancer patients' long-term outcomes and examine the association between ctDNA levels right after initial therapy and distant recurrence-free survival. Exact and WSG are also interested in learning how the predictive and prognostic information provided by Oncotype DX might be used together with the MRD test in clinical practice.

Exact has another validation study of the liquid biopsy test ongoing in colorectal cancer, the CORRECT-MRD II study. That study is focusing on predicting recurrence among 750 patients with stage II or III colorectal cancer who have undergone complete surgical resection over a follow-up period of three to five years.

"The WSG's ADAPT study program examines ways to achieve patient-specific decision-making for the treatment of early breast cancer based on biological markers," Nadia Harbeck, scientific director of the WSG and head of the Breast Center at LMU Klinikum Munich, Germany, said in a statement. "Partnering with our long-time collaborators at Exact Sciences to evaluate the association of post-initial therapy, pre-recurrence ctDNA with distant recurrence-free interval is a worthy addition to our program and will help change the treatment and monitoring program for solid tumors."

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