Freenome, a company focused on early cancer detection through blood-based screening tests, has entered into an exclusive collaboration with Roche to expand and commercialize its cancer screening technology in markets outside the United States. As part of the agreement, Freenome will also assess Roche’s upcoming Sequencing by Expansion (SBX) platform for potential use in future product development.
Under the deal, Roche will obtain exclusive ex-U.S. rights to develop “kitted” versions of Freenome’s tests — integrated packages combining assay and software designed for decentralized processing without the need for a central lab. With Roche’s established leadership in decentralized diagnostics, this partnership is expected to speed up the availability of Freenome’s tests in select international regions. Freenome will continue to hold rights to centralized testing outside the U.S., along with all U.S. rights, in line with its existing agreement with Exact Sciences.
The agreement builds on the companies’ ongoing research collaboration involving Roche’s Elecsys technology for protein and multiomic analysis. The new phase of work will also incorporate SBX to further optimize Freenome’s cell-free DNA (cfDNA) cancer screening solutions.
Freenome will additionally gain access to Roche’s plasma sample cohorts, which will support the acceleration of personalized screening tests across several cancer types, including lung cancer.
“We are delighted to deepen our R&D partnership with Roche to enhance our multiomic blood-based cancer screening platform and accelerate our test pipeline,” said Aaron Elliott, Ph.D., Freenome chief executive officer. “Combining our technology with Roche’s expertise in kit development and its footprint outside the United States will enable us to extend our reach globally and help more patients.”
The announcement follows Freenome’s August news that Exact Sciences secured exclusive U.S. commercialization rights for its colorectal cancer blood-based screening test, which is now under FDA pre-market approval review.
Roche has been a significant backer of Freenome, having led a $254 million financing round in February 2024. The latest licensing and R&D agreement — valued at over $200 million — includes a $75 million equity instrument, milestone-based payments, and royalties on sales of Freenome tests outside the U.S.
“This collaboration demonstrates our commitment to blood-based early cancer detection, which has the potential to transform disease management. Furthermore, it represents an example of our intent to establish high-impact clinical applications for our groundbreaking sequencing by expansion technology,” said Matt Sause, chief executive officer of Roche Diagnostics.