Flatiron Health and Exact Sciences drive innovation in MRD testing through RWE

Flatiron Health and Exact Sciences have partnered to advance molecular residual disease (MRD) research by leveraging real-world evidence (RWE), evaluating the Oncodetect™ test’s ability to detect ctDNA and predict cancer recurrence in a broad range of solid tumors.

Flatiron Health, a leading health tech company focused on improving cancer care and advancing research, and Exact Sciences, a provider of cancer screening and diagnostic tests, have announced a partnership aimed at accelerating clinical evidence generation for Exact Sciences’ molecular residual disease (MRD) test, Oncodetect™. The partnership leverages Flatiron’s leading-edge clinical research platform to study a broad range of solid tumor types, supporting the development of improved cancer recurrence monitoring.

Advancing MRD research in real-world settings

Flatiron Health, an independent affiliate of the Roche Group, specializes in RWE and clinical research in oncology, while Exact Sciences focuses on cancer screening and diagnostics. Their partnership seeks to generate clinical evidence by incorporating real-world data (RWD) and ensuring inclusivity in clinical research. Community care settings, often underrepresented in clinical trials, will be central to this study. MRD testing is an emerging area in oncology, with potential to enhance cancer recurrence detection and management.

“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 of Clinical Research at 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 integrating Flatiron Health’s expertise in RWE with Exact Sciences’ work in precision oncology, the partnership seeks to facilitate clinical evidence development and the availability of new diagnostic tools for cancer care.

Study details and key milestones

The study is a prospective observational trial designed to evaluate the effectiveness of a tumor-informed circulating tumor DNA (ctDNA) test in detecting MRD and predicting cancer recurrence. The trial has already reached a key milestone, enrolling its first patient in under six months from conception.

Key aspects of the study include:

• Study overview: Observational research assessing the Oncodetect test’s ability to detect MRD and predict recurrence in solid tumors.
• Enrollment goal: 1350 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 longitudinal data on the test’s performance.
• Focus areas: Applications in pre- and post-surgical settings, post-definitive therapy, and surveillance monitoring.

Brian Baranick, general manager of Precision Oncology at Exact Sciences, stated,

“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.” 

The role of MRD testing in cancer care

MRD testing involves detecting ctDNA, which are shed into the bloodstream by tumors. The presence of ctDNA can indicate cancer recurrence, making MRD monitoring a valuable tool for oncologists. The Oncodetect test applies whole exome sequencing technology to identify genomic alterations in tumor DNA and detect their presence in ctDNA. This approach enables more precise monitoring and may facilitate earlier intervention for patients at risk of recurrence.