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, today announced a strategic partnership aimed at accelerating clinical evidence generation for Exact Sciences’ molecular residual disease test (MRD), OncodetectTM. 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.
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.
“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.
“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.
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.
About Flatiron Health
Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.
About Flatiron Clinical Research
At Flatiron Health, we’re transforming clinical research through technology and services that integrate research into everyday clinical care. Our experience to-date in real-world evidence and at the point-of-care, combined with our deep understanding of the clinical study landscape, uniquely positions us to tackle some of the persistent barriers and challenges associated with prospective research — from Phase I–III clinical trials to prospective post-marketing studies.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.
About the Oncodetect test
Molecular residual disease (MRD) refers to the presence of tumor-specific DNA in the body. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the bloodstream by tumors, and their presence may indicate cancer. Exact Sciences’ MRD offering leverages our in-house capabilities in whole exome sequencing to offer a tumor-informed MRD test for a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the Oncodetect test may enable the detection of ctDNA before, during, and after treatment. This critical information can guide therapy decisions and monitor for cancer recurrence.
Forward Looking Statements
This news release contains forward-looking statements concerning our expectations,
anticipations, intentions, beliefs, or strategies regarding the future. These forward-
looking statements are based on assumptions that we have made as of the date
hereof and are subject to known and unknown risks and uncertainties that could
cause actual results, conditions and events to differ materially from those
anticipated. Therefore, you should not place undue reliance on forward-looking
statements. Risks and uncertainties that may affect our forward-looking statements
are described in the Risk Factors sections of Exact Sciences’ reports filed with the
Securities and Exchange Commission.
Contacts
Flatiron Health
Nina Toor
Nina.toor@flatiron.com
Exact Sciences
U.S. Media
Lisa Warshaw
lwarshaw@exactsciences.com
Investors
Erik Holznecht
eholznecht@exactsciences.com
