On August 2, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported that it has entered a collaboration agreement with the West German Study Group (WSG), an international research institution that focuses on practice-changing clinical studies in breast cancer (Press release, Exact Sciences, AUG 2, 2022, View Source [SID1234617262]). Together, Exact Sciences and WSG plan to conduct a prospective, multicenter validation study in hormone receptor (HR)-positive, HER2-negative early breast cancer patients. The study is intended to demonstrate the ability of Exact Sciences’ tumor-informed ctDNA liquid biopsy test to detect minimal residual disease (MRD) and to collect important long-term follow-up and outcome data.

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The combined analysis, called ADAPT Triad, is expected to include data from approximately 3,000 German patients enrolled in two ongoing WSG ADAPT trials and one WSG registry study. All patients included in the analysis are stratified using the Oncotype DX Breast Recurrence Score test. The study is part of Exact Sciences’ global initiative to generate clinical validation data for its tumor-informed ctDNA MRD liquid biopsy test, currently in development.

"This ADAPT Triad project with WSG offers a tremendous opportunity to help inform treatment decisions and recurrence monitoring, and ultimately improve future outcomes for breast cancer patients," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "In addition to helping validate our MRD assay, we’re also eager to better understand the potential synergies involving the predictive and prognostic information provided by our Oncotype DX Breast Recurrence Score test. WSG’s expertise in breast cancer research makes them ideal collaborators to conduct these important MRD studies in HR positive, HER2-negative early breast cancer."

The ADAPT Triad MRD analysis study in breast cancer builds on Exact Sciences and the National Surgical Adjuvant Breast and Bowel Project’s (NSABP) CORRECT-MRD II clinical validation study to detect MRD in colorectal cancer patients. These studies will help create a solid evidence foundation for Exact Sciences’ MRD program in two core cancer types where the company has established leadership.

"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," said Professor Nadia Harbeck, Scientific Director of the WSG and Head of the Breast Centre at LMU Klinikum Munich, Germany. "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."

About Minimal Residual Disease
Minimal residual disease (MRD) refers to the presence of tumor-specific DNA in the body after cancer treatment. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the blood by solid tumors as part of the tumor growth cycle. Their presence may indicate that a tumor is likely to return. Solid tumors are typically undetected until they are advanced enough to be picked up by a radiologic image or physician examination. The detection of ctDNA at extremely low levels has the potential to provide crucial insights that may help discover cancer recurrence earlier and inform treatment decisions.

About Exact Sciences’ MRD Program
The Exact Sciences’ MRD program is powered by our in-house capabilities to advance a tumor-informed or a tumor-naïve solution, with an initial focus on tumor-informed (bespoke) with whole exome or whole genome sequencing. This approach identifies somatic genomic alterations in DNA extracted from the patient’s tumor tissue and detects a subset of these mutations in ctDNA present in the patient’s blood. The MRD test that Exact Sciences is developing is intended for patients diagnosed with solid tumor malignancies to detect ctDNA before, during, and after cancer treatment. Such information may be used for guidance of adjuvant therapy decisions and/or for monitoring of cancer recurrence, in conjunction with other clinicopathological findings, providing more than 12 million testing opportunities in the United States alone.1