Freenome, a biotechnology company focused on pioneering early cancer detection, has entered into an exclusive licensing agreement with Exact Sciences to drive forward the commercialization of its blood-based colorectal cancer (CRC) screening test. The agreement gives Exact Sciences the right to market the CRC blood test technology in the United States, but Freenome is still able to use the test in combination with other cancer screens, such as those for lung cancer and over ten other malignancies that are presently being developed.
Through this collaboration, Exact Sciences aims to accelerate the CRC test’s adoption by utilizing its expansive commercial ecosystem, which includes access to nearly 400 electronic medical record-integrated health systems, more than 865 insurance providers, a network of over 260,000 prescribing physicians, and an existing base of millions of patients familiar with Cologuard®. Initially, Freenome will be responsible for processing and analyzing the tests, as well as providing the results, while also continuing its efforts to work directly with healthcare providers to identify patients eligible for multiple screenings.
Freenome’s CEO, Aaron Elliott, expressed enthusiasm about the agreement, emphasizing that the partnership could significantly speed up access to their CRC test, which, if approved, is expected to be among the most effective available. He noted that the collaboration would not only help expand the company’s reach into primary care but also support ongoing development of its multiomics platform with new funding.
Exact Sciences’ CEO, Kevin Conroy, noted the strategic value of integrating Freenome’s blood-based screening technology into their ExactNexus™ platform, highlighting its potential to complement Cologuard Plus™ and provide broader access to unscreened populations.
The agreement includes several financial components: an initial $75 million upfront payment, up to $700 million in potential milestone payments linked to regulatory approvals and guideline ratings, royalty payments that scale with profitability, $20 million for joint research and development over three years, and a $50 million equity investment. Freenome will gain access to comprehensive multimodal data, which will be used to refine future AI and machine learning models across various cancer types.
In Freenome’s pivotal PREEMPT CRC® Study, which involved nearly 49,000 adults, the company’s test detected over 81% of CRC cases, including 63.5% of stage 1 cancers, and approximately 14% of advanced precancerous lesions, achieving a specificity of 90.4%. A next-generation version of the test, developed through assay and algorithm enhancements, has shown even better performance in a separate head-to-head study. Regulatory engagement is ongoing, and Freenome is preparing for FDA submission following the initial version’s approval.
As colorectal cancer remains the second leading cause of cancer-related deaths in the U.S., with over 50,000 deaths annually, Freenome’s test offers a promising alternative for early detection. The company’s vision is to build a personalized early detection system that incorporates multiple biomarkers and AI to identify cancers at their most treatable stages. Freenome is committed to a future where cancer may be identified and treated more efficiently, with an emphasis on increasing screening accessibility and customizing testing to each person’s risk level.
