Accelerating Cancer Care Innovation: Flatiron Health and Exact Sciences Partner to Advance Molecular Residual Disease Testing
MRD Testing Flatiron Health, a pioneering healthtech company focused on transforming cancer care and advancing research, has announced a strategic partnership with Exact Sciences, a leader in cancer screening and diagnostic solutions. This collaboration aims to accelerate the generation of clinical evidence for Exact Sciences’ molecular residual disease (MRD) test, Oncodetect™. By leveraging Flatiron’s cutting-edge clinical research platform, the partnership will explore the utility of Oncodetect across a wide range of solid tumor types. A significant milestone has already been achieved with the enrollment of the first patient, underscoring the rapid progress and strong alignment between the two organizations.
The partnership is particularly noteworthy for its focus on generating real-world clinical evidence within community care settings—environments that are often underrepresented in traditional clinical trials. This approach is especially critical in the emerging field of MRD testing, where oncologists are still determining how these innovative tools can be integrated into precision cancer care to improve patient outcomes. By including diverse patient populations, the study aims to ensure that the findings are broadly applicable and reflective of real-world cancer care scenarios.
Harnessing Next-Generation Evidence Generation
At the heart of this collaboration is Flatiron Health’s next-generation prospective evidence platform, MRD Testing designed to address critical gaps in clinical research by embedding studies into routine care. This innovative approach allows for the collection of robust, real-world data with unprecedented speed and efficiency. According to Alex Deyle, General Manager of Clinical Research at Flatiron Health, “Our partnership with Exact Sciences leverages Flatiron’s advanced prospective evidence platform, which we built to generate high-quality clinical evidence seamlessly integrated into everyday care. Our team of experts, extensive network of experienced sites, tailored research operations, and state-of-the-art technology have enabled us to conduct more efficient and representative prospective studies.”
Flatiron’s platform is uniquely positioned to reduce the administrative burden on MRD Testing clinical sites while ensuring high-quality data collection. By streamlining processes and focusing on pragmatic study designs, the partnership seeks to accelerate the development of clinical evidence for Oncodetect, ultimately bringing the benefits of MRD testing to patients faster.
Advancing Precision Oncology Through Collaboration
For Exact Sciences, MRD Testing this partnership represents a significant step forward in its mission to advance cancer diagnostics, with a particular emphasis on MRD testing. Brian Baranick, General Manager of Precision Oncology at Exact Sciences, emphasized the importance of this collaboration: “Our work with Flatiron Health marks a pivotal moment in the evolution of cancer diagnostics. This partnership will generate robust clinical evidence for the Oncodetect test across multiple solid tumor types, helping to refine cancer recurrence monitoring and ensuring our innovations meet the needs of patients and clinicians alike.”
The ultimate goal is to integrate Oncodetect into clinical practice as a tool for detecting MRD and predicting cancer recurrence, enabling earlier interventions and personalized treatment strategies. By studying the test’s performance in real-world settings, the companies aim to demonstrate its value in improving patient outcomes and advancing precision oncology.
Milestone Achieved: First Patient Enrolled
A key highlight of the partnership is the rapid enrollment of the first patient, MRD Testing achieved in under six months from the study’s conception. This accomplishment reflects the strong collaboration between Flatiron Health and Exact Sciences, as well as their shared commitment to executing the study with precision and efficiency. The swift enrollment also underscores the potential of pragmatic study designs to expedite clinical research without compromising quality or rigor.
Study Design and Objectives
The study is structured as a prospective observational trial designed to evaluate the use of a tumor-informed circulating tumor DNA (ctDNA) test for detecting MRD and predicting cancer recurrence in solid tumors. Key details of the study include:
- Enrollment Goal: The study aims to recruit 1,350 patients receiving standard-of-care therapy in community practice settings. By focusing on community care, the study ensures that its findings are applicable to a broad and diverse patient population.
- Data Collection Process: Participants will undergo sequential blood draws during and after therapy for up to five years. These samples will provide critical data on the performance of the Oncodetect test in various clinical contexts, including pre- and post-surgical settings, post-definitive therapy, and surveillance.
- Focus Areas: The study will explore the utility of Oncodetect in multiple phases of cancer care, including early detection of MRD, prediction of recurrence, and long-term monitoring of patients in remission.
Addressing Gaps in MRD Testing
Molecular residual disease testing is an emerging field with immense potential to transform cancer care. By detecting trace amounts of cancer DNA in the blood after treatment, MRD tests like Oncodetect can identify patients at high risk of recurrence, even when no visible signs of disease are present. This capability enables clinicians to tailor follow-up care and potentially intervene earlier, improving survival rates and quality of life for patients.
However, integrating MRD testing into routine clinical practice requires robust evidence demonstrating its effectiveness across different tumor types and patient populations. Traditional clinical trials often fail to capture the diversity of real-world cancer care, leaving critical questions unanswered. By conducting this study in community care settings, Flatiron Health and Exact Sciences aim to bridge this gap and provide actionable insights that reflect the realities of modern oncology.
The Power of Real-World Data
One of the most significant advantages of this partnership is its reliance on real-world data (RWD). Unlike controlled clinical trials, which often exclude certain patient groups or limit external validity, RWD provides a more comprehensive picture of how treatments and diagnostics perform in everyday practice. Flatiron Health’s expertise in curating and analyzing RWD ensures that the study results will be both rigorous and relevant to clinicians and patients.
By combining Flatiron’s data capabilities with Exact Sciences’ innovative diagnostic technologies, the partnership exemplifies the potential of cross-industry collaborations to drive meaningful advancements in cancer care. Together, the companies are setting a new standard for how clinical evidence is generated and applied to improve patient outcomes.
