Freenome, a biotechnology company pioneering an early cancer detection platform, has officially announced an exclusive license agreement with Exact Sciences to advance the commercialization of its colorectal (CRC) blood-based screening test, including the U.S. commercial rights and the underlying technology.
To understand the significance of such a development, we must take into account how CRC happens to be the world’s second deadliest cancer, causing more than 50,000 deaths per year in the U.S. alone.
However, when CRC is detected early, the survival rate can breach the mark of 90%. Still, more than 40% of screening-eligible adults are not up to date with current screening guidelines.
Focused on closing the stated gap, Freenome would go onto develop a multiomics platform, capable of analyzing genomic, epigenomic, and proteomic biomarkers and eventually applying AI/ML-based models to detect cancer-specific signals in the bloodstream, including those derived from circulating tumor DNA (ctDNA).
The company’s CRC screening blood test would markedly bank upon the given mechanism to identify specific methylation signatures in ctDNA at single-base resolution.
“Population-level CRC screening is the gateway for our broader vision of personalized early cancer detection and, ultimately, disease detection beyond cancer,” said Riley Ennis, co-founder and chief product officer at Freenome. “This partnership gives us the commercial scale and real-world data we need to improve our existing tests and accelerate development of the 10-plus other cancer types in our pipeline, and then expand from there.”
Anyway, under the new licensing deal, Freenome will retain complete controls over its CRC blood test when it is ordered in combination with more cancer screening tests, including for lung and more than 10 other initial cancer indications the company is pursuing. Markedly enough, the company will initially lead test processing, analysis, and return of results..
Exact Sciences, on the other hand, will have the responsibility of accelerating market adoption of the CRC blood test. This the company will likely achieve by leveraging its commercial infrastructure to streamline access of nearly 400 health systems with EMR integration; more than 865 in-network payers; more than 260,000 ordering physicians; and relationships with millions of patients who have been prescribed a Cologuard® test.
“This agreement in blood-based cancer screening accelerates our ability to bring new solutions to market,” said Kevin Conroy, chairman and chief executive officer of Exact Sciences Corp. “As an additional option to Cologuard Plusâ„¢, this enhances our reach to unscreened patients. By integrating with our ExactNexusâ„¢ technology platform and commercial infrastructure, we’re positioned to scale quickly and drive meaningful impact.”
Talk about the stated licensing agreement on a slightly deeper level, it includes an upfront payment of $75 million; $200 million in milestone payments associated with FDA first-line approval of the CRC blood test and a future test version, and another $500 million if the test is rated as an A or B test in the United States Preventive Services Taskforce (USPSTF) guidelines.
Beyond that, it also stipulates royalties on test sales (expected to ramp to 10% once gross margins hit certain targets); $20 million in funding for joint R&D development expenses leveraging the technology for three years; as well as an equity investment of $50 million.
The development in question also delivers a rather interesting follow-up to Freenome’s pivotal PREEMPT CRC® Study, which involved 48,995 average-risk adults. Going by the available details, this screening test detected 81.1% of CRC, including 63.5% at stage 1 and 13.7% of advanced precancerous lesions (APL), with a specificity of 90.4%.
Apart from that, the research deployed an average-risk, pre-colonoscopy arm to mirror the intended use population of PREEMPT CRC. For the future, Freenome already has plans in place to submit a supplemental premarket approval application for the next-generation test.
“We are excited to enter into this agreement with Exact Sciences, which represents a pivotal moment in our mission to detect cancer in its earliest, most treatable stages,” said Aaron Elliott, Ph.D., chief executive officer of Freenome. “With this agreement, our CRC blood test – which we believe is best in class, if approved – will be available much sooner to millions of patients. Freenome will be able to augment our commercial reach and integration into primary care workflows.