Exact Sciences has acquired exclusive US rights to Freenome’s current and future blood-based colorectal cancer screening tests.
The agreement allows Exact Sciences to commercialise Freenome’s tests, which have shown promising results in early detection of colorectal cancer.
Freenome’s test achieved 81% sensitivity for colorectal cancer and 14% for advanced precancerous lesions at 90% specificity, as published in JAMA.
Under the agreement, Freenome will receive $75m by November 2025, with potential milestone payments up to $700m, and royalties up to 10% based on profits.
The payments are contingent upon achieving specific FDA approvals and performance benchmarks.
Exact Sciences has committed $20m annually over three years for joint research and development.
Exact Sciences chairman and CEO Kevin Conroy said: “This exclusive license expands our leadership in cancer screening with the addition of blood-based options.
“Cologuard Plus is the most accurate guideline-included non-invasive colorectal cancer screening test.
“We’re now able to offer a complementary blood-based option to the over 50 million unscreened Americans, supported by our broad commercial reach, ExactNexus technology platform, and deep relationships with health systems and payers.”
Exact Sciences will use its infrastructure, and relationships with health systems, payers, and physicians to enhance market adoption of the colorectal cancer test.
Freenome will lead test processing and analysis, while also developing a personalised cancer detection programme.
The initiative aims to offer multiple tests tailored to individual risk profiles, optimising sensitivity and specificity.
Freenome’s multiomics platform, which integrates genomic, epigenomic, and proteomic biomarkers with AI/ML models, underpins the colorectal cancer screening test.
The company is also advancing its lung cancer test, targeting a 2026 launch.
Furthermore, Exact Sciences’ agreement includes purchasing a $50m senior convertible note from Freenome, due in 2030, with a 5% coupon rate.
Freenome CEO Aaron Elliott said: “Our test performance represents an important step toward closing the screening gap in the United States.
“Exact Sciences brings the scale, reach, and proven track record to maximise its impact and deliver this technology to patients faster and with greater certainty.”
