NEW YORK – Flatiron Health and Exact Sciences said Wednesday that they have entered a strategic partnership to hasten the generation of real-world clinical evidence for Exact Sciences' molecular residual disease (MRD) test, Oncodetect.
The companies aim to analyze test results and outcomes amongst diverse patient populations treated in the type of community care settings that are relatively underrepresented in clinical trials.
Like many other MRD assays now jockeying for market share in the care of patients with solid tumors, Exact's assay uses upfront tumor tissue sequencing to design personalized panels that are then used to detect cancer-associated DNA mutations circulating in the blood stream.
According to Alex Deyle, Flatiron's general manager of clinical research, the partnership is employing Flatiron's next-generation prospective evidence platform, which the company designed for this precise purpose. "Our in-house team of experts, experienced site network, fit-for-purpose research operations, and cutting-edge technology that focuses on reducing site burden, has enabled us to run more efficient and representative prospective studies," Deyle said in a statement.
Exact and Flatiron aim to enroll 1,350 patients undergoing standard-of-care therapy in community practice settings. These individuals will undergo sequential blood draws during and after therapy for up to five years, generating data on the Oncodetect test’s ability to detect the recurrence or reemergence of cancer before symptoms arise or before it becomes evident on imaging scans.
Financial terms of the deal were not disclosed.