Freenome Announces Exclusive Agreement with Roche to Expand Technology Collaboration and Develop and Commercialize Cancer Screening Tests Outside the U.S.

– Partnership focuses on "kitted" tests in ex-U.S. markets, enabling accelerated access through a decentralized model –

– Deal potentially worth $200+ million increases Roche's investment in Freenome with $75 million equity instrument and R&D support through innovative applications and technology collaboration –

BRISBANE, Calif., Nov. 18, 2025 /PRNewswire/ -- Freenome, an early cancer detection company developing blood-based screening tests, today announced a strategic collaboration agreement with Roche to commercialize Freenome's cancer screening technology in international markets. In addition, Freenome will evaluate Roche's forthcoming Sequencing by Expansion (SBX) technology for future development applications.

Roche is acquiring exclusive ex-U.S. rights to develop "kitted" tests, which involve packaging the software and assay to enable decentralized test processing and analysis, without a large, centralized processing lab. Roche is the global leader in decentralized testing, and this partnership will accelerate the availability of Freenome's tests in certain ex-U.S. markets. Freenome retains rights to ex-U.S. centralized testing as well as all U.S. rights, subject to its pre-existing license to Exact Sciences.

In addition to the companies' ongoing R&D collaboration to leverage Roche's Elecsys technology for protein and other multiomic analysis, the companies will work together to leverage the SBX technology to enhance Freenome's cell-free DNA (cfDNA) cancer screening tests. Freenome will also gain access to Roche plasma sample cohorts that will help accelerate development of personalized screening tests for multiple types of cancer, 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."

In August, Freenome announced that Exact Sciences had acquired the exclusive U.S. commercialization rights to its colorectal cancer blood-based screening test, which has been submitted for pre-market approval to the U.S. Food and Drug Administration (FDA).

Roche is a committed investor in Freenome, having previously led a $254 million financing round in February 2024. This potentially $200+ million licensing and R&D agreement includes a $75 million equity instrument; milestone payments; and royalties on ex-U.S. test sales reflecting the significant global market potential.

"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," added Matt Sause, chief executive officer of Roche Diagnostics.

About Freenome
Freenome is breaking barriers to early cancer detection with a suite of blood tests built on its multiomics platform. The company recognizes that no single technology can identify every cancer due to the disease's inherent heterogeneity. Freenome's multimodal approach combines molecular biology and assays with computational biology, machine learning and multiple data types to tune into cancer's subtlest cues, even at the earliest stages of the disease.

With the convenience of a standard blood draw, Freenome aims to empower everyone to access recommended cancer screenings. The company is partnering with healthcare organizations and population health decision-makers to integrate its technology and software platform, making cancer detection easier and more accessible. Freenome is headquartered in Brisbane, California. Find out more at www.freenome.com and visit us on LinkedIn.

SOURCE Freenome Holdings, Inc.