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Exact Sciences, NSABP Validating Ability of ctDNA Test to Detect MRD in Colorectal Cancer Patients

NEW YORK – Exact Sciences said on Tuesday that it has agreed to work with the National Surgical Adjuvant Breast and Bowel Project, or NSABP, to conduct a prospective, multicenter validation study demonstrating the ability of Exact's circulating tumor DNA test to detect minimal residual disease in colorectal cancer patients.

The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients with stage II and III CRC at 35 study sites in the US and Canada. It's part of Exact's global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test.

In January, the company secured a worldwide exclusive license to the Targeted Digital Sequencing liquid biopsy method from the Translational Genomics Research Institute, or TGen, for use in minimal residual disease testing. Then in February, Exact announced its acquisition of sequencing lab Ashion Analytics from TGen as part of its strategy to build an end-to-end cancer testing pipeline, including diagnostics for MRD.

Exact noted that patient-specific MRD testing also has the potential to fit in with the predictive and prognostic data provided by the company's Oncotype testing platform, in order to further inform treatment decisions to help improve patient outcomes. It plans to explore the potential of MRD testing across all solid tumor types.

"Our longstanding relationship with the NSABP, through our work to develop and validate the Oncotype DX Breast Recurrence Score and Colon Recurrence Score tests, represents a remarkable collaboration between academic and industry partners," Rick Baehner, Exact's chief medical officer of precision oncology, said in a statement. "This relationship has fueled major advancements in understanding the role of molecular profiling in breast and colon cancer. NSABP's expertise in colon research makes them ideal collaborators to conduct this important MRD study in colorectal cancer."

Exact and the NSABP, a cooperative group founded by the National Cancer Institute, are also working with patient advocacy organization Fight Colorectal Cancer to help inform MRD study designs and identify potential barriers to study participation, particularly in underserved populations.