Freenome Holdings Inc, a California-based biotechnology company pioneering an early cancer detection platform, announced on Wednesday an exclusive licence agreement with Wisconsin-based molecular diagnostics company Exact Sciences to advance the commercialisation of its colorectal (CRC) blood-based screening test, including the US 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 organisations to identify patients who are eligible for multiple tests.

The terms include: an upfront payment of USD75m; USD200m in milestone payments associated with FDA first-line approval of the CRC blood test and a future test version; USD500m 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); USD20m in funding for joint R&D development expenses leveraging the technology for three years; and an equity investment of USD50m. Freenome will also have access to all multimodal data from patients to power future AI/ML models across multiple cancer indications.

Freenome says that in US-census-adjusted data from its 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%.