First patient enrolled in prospective clinical study evaluating a tumor-informed test for monitoring cancer recurrence across multiple solid tumor types in 1,350 patients in diverse community care settings

Flatiron Health, a leading healthtech company dedicated to improving cancer care and advancing research, and Exact Sciences, a leading provider of cancer screening and diagnostic tests, announced a strategic partnership aimed at accelerating clinical evidence generation for Exact Sciences’ molecular residual disease test (MRD), Oncodetect. The partnership leverages Flatiron’s leading-edge clinical research platform to study a broad range of solid tumor types. The companies have already achieved first patient enrolled, marking a key milestone for the partnership.

“The partnership will generate robust clinical evidence for the Oncodetect test across multiple solid tumor types, helping improve cancer recurrence monitoring and ensuring our innovations address patient needs for better outcomes.”

Together, the companies aim to generate clinical evidence within a real-world setting and diverse patient populations by utilizing community care settings, typically underrepresented in clinical trials. This is particularly important in the emerging space of MRD, where oncologists continue to explore how these tests can integrate into delivering high-quality, precision cancer care.

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“Our partnership with Exact Sciences leverages Flatiron’s next-generation prospective evidence platform, which we designed to address critical evidence gaps via studies embedded into routine care, with unprecedented speed,” said Alex Deyle, general manager, Clinical Research, Flatiron Health. “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.”

By harnessing the power of a novel prospective clinical evidence generation platform and pragmatic study design, Flatiron Health and Exact Sciences are committed to accelerating the process and reducing the burden of clinical evidence development.

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“Our collaboration with Flatiron Health represents a significant step in advancing cancer diagnostics, with a particular focus on MRD,” said Brian Baranick, general manager of Precision Oncology at Exact Sciences. “The partnership will generate robust clinical evidence for the Oncodetect test across multiple solid tumor types, helping improve cancer recurrence monitoring and ensuring our innovations address patient needs for better outcomes.”

First Patient Enrolled

The study’s first patient was enrolled in under six months from conception—a notable achievement reflecting a strong collaboration and focus on execution.

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Study Highlights

  • Study Overview: A prospective observational study to evaluate the use of a tumor-informed ctDNA test for detecting MRD and predicting cancer recurrence in solid tumors.
  • Enrollment Goal: 1,350 patients receiving standard-of-care therapy in community practice settings.
  • Process: Patients will undergo sequential blood draws during and after therapy for up to five years, providing data on the Oncodetect test’s performance.
  • Focus Areas: Applications in the pre- and post-surgical, post-definitive therapy and surveillance settings.

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Source: Businesswire