Healthtech company Flatiron Health and Exact Sciences have announced a partnership to advance clinical evidence generation for molecular residual disease (MRD) testing.
Both companies will advance a prospective study to generate evidence for Exact Sciences’ MRD test, Oncodetect.
This partnership uses Flatiron’s advanced clinical research platform to study a range of solid tumour types.
The first patient has already been enrolled in the study, marking a key milestone in its progress. The patient was recruited in under six months from the study’s conception.
Flatiron Health said that the study will help oncologists explore how these tests can enhance precision cancer care.
The Oncodetect test could enable early detection of circulating tumour DNA (ctDNA) before, during, and after treatment by identifying somatic genomic alterations in tumour DNA and detecting a subset in circulating tumour DNA (ctDNA) from blood.
Exact Sciences precision oncology general manager Brian Baranick said: “Our collaboration with Flatiron Health represents a significant step in advancing cancer diagnostics, with a particular focus on MRD.
“The partnership will generate robust clinical evidence for the Oncodetect test across multiple solid tumour types, helping improve cancer recurrence monitoring and ensuring our innovations address patient needs for better outcomes.”
Using a clinical evidence generation platform and pragmatic study design, both partners aim to accelerate and simplify clinical evidence development.
The observational study will evaluate a tumour-informed ctDNA test for detecting MRD and predicting cancer recurrence in solid tumours.
It will enrol 1,350 patients receiving standard-of-care therapy in community practice settings, which are typically underrepresented in clinical trials.
Patients will undergo sequential blood draws during and after therapy for up to five years to assess the Oncodetect test’s performance.
The study will focus on applications in pre- and post-surgical, post-definitive therapy, and surveillance settings.
Flatiron Health clinical research general manager Alex Deyle said: “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.
“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.”
Exact Sciences, a provider of cancer screening and diagnostic tests, also offers Oncotype and Cologuard tests. In October 2024, the US Food and Drug Administration (FDA) approved the Cologuard Plus test for colorectal cancer (CRC) screening.
