– Deal worth up to $885 million based on achievement of certain regulatory and screening guideline milestones – 

– Final module for the first version of Freenome's colorectal cancer test has been submitted to FDA; approval and commercial launch anticipated in 2026 – 

– Availability of real-world patient and multimodal molecular data will feed AI/ML models to improve Freenome's platform –  

BRISBANE, Calif., Aug. 6, 2025 /PRNewswire/ -- Freenome, a biotechnology company pioneering an early cancer detection platform, today 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. Freenome retains the rights for its CRC blood test when it is ordered in combination with additional cancer screening tests, including for lung and more than 10 other initial cancer indications the company is pursuing.

Exact Sciences will accelerate market adoption of the CRC blood test by leveraging its commercial infrastructure to streamline access to 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. Freenome will initially lead test processing, analysis and return of results while continuing to work with healthcare organizations to identify patients who are eligible for multiple tests.

"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. Additionally, Freenome will be able to augment our commercial reach and integration into primary care workflows, as we advance the development of our multiomic early cancer detection platform with the additional capital."

"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 Plus™, this enhances our reach to unscreened patients. By integrating with our ExactNexus™ technology platform and commercial infrastructure, we're positioned to scale quickly and drive meaningful impact."

The terms include: 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; $500 million if the test is rated as an A or B test in the United States Preventive Services Taskforce (USPSTF) guidelines; 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; and an equity investment of $50 million. Freenome will also have access to all multimodal data from patients to power future AI/ML models across multiple cancer indications.

"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, Freenome's co-founder and chief product officer. "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."

CRC Screening Test Performance

In U.S.-census-adjusted data from Freenome's pivotal PREEMPT CRC® Study involving 48,995 average-risk adults, the company's CRC 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%.¹

As part of its test versioning strategy, Freenome has undertaken a comprehensive upgrade of the assay, automation and algorithm to develop an improved version of its CRC test. In a head-to-head study of the two versions on a primarily prospectively collected independent cohort, this "next-generation" version has shown even stronger performance in CRC and APL detection. The study included an average-risk, pre-colonoscopy arm to mirror the intended use population of PREEMPT CRC. Detailed data will be presented at an upcoming scientific meeting. Freenome is in active discussions with the FDA and plans to submit a supplemental premarket approval application for the next-generation test, following the approval of the first version.

CRC is the world's second deadliest cancer, with more than 50,000 deaths per year in the U.S. alone.^2,3 When CRC is detected early, the survival rate is over 90%, yet more than 40% of screening-eligible adults are not up to date with current screening guidelines.⁴ The availability of less invasive, more accessible screening options – such as blood-based tests – has been shown to increase screening rates.⁵

Freenome and Early Cancer Detection

To pursue its vision of personalized early cancer detection, Freenome developed a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers and applies 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 was built on this platform and identifies specific methylation signatures in ctDNA at single-base resolution.

Beyond CRC R&D and progressing its lung cancer laboratory-developed test toward an anticipated launch in 2026, Freenome will focus on developing its "personalized cancer early detection" program. The company's goal is to create a common lab platform with custom panels and classifiers to offer multiple tests to an individual, based on risk profiles and guideline eligibility. Targeting high-, elevated-, and average-risk populations based on the unmet need allows the tests to be optimized for higher sensitivity at clinically acceptable specificity.

About Freenome

Freenome is breaking barriers to early cancer detection with a suite of blood-based 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.

*Freenome's colorectal cancer blood-based screening test is referred to as  "SimpleScreen™ CRC Colorectal Cancer screening blood test" in the company's Premarket Approval Application to the U.S. Food and Drug Administration.

References

1. Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA–based blood test to screen for colorectal cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515
2. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer stat facts: common cancer sites. Accessed Aug. 6, 2025. https://seer.cancer.gov/statfacts/html/common.html
3. World Health Organization. Cancer. Published Feb. 3, 2025. Accessed Aug. 6, 2025. https://www.who.int/news-room/fact-sheets/detail/cancer
4. Survival rates for colorectal cancer. American Cancer Society. Accessed Aug. 6, 2025. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
5. Liang PS, Zaman A, Kaminsky A, et al. Clin Gastroenterol Hepatol. 2023 Apr 8;21(11):2951–2957.e2. doi: 10.1016/j.cgh.2023.03.036

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SOURCE Freenome Holdings, Inc.