Exact science team with Freenome team for guardian health during colorectal cancer screening
Accurate and scientific candidates for colorectal cancer blood tests are lacking in their critical studies, but the company is still looking for alternatives to liquid biopsy, which is first marketed in this type of cancer and will be conducted with the help of competitors. Exact science is getting the right to the test from Freenome, which is closer to the market than its failed internal candidates.
The exact science is paying $75 million for blood tests in the U.S. to pay for U.S. rights. Another $700 million is related to achieving milestones.
Precise science has been identified in the Colorectal Cancer Screening for Colorectal Cancer Based in Madison, Wisconsin. Both are stool-based tests that require users to send samples to a lab to detect cancer DNA. Even as the market for these tests grows, the screening sector has been driving the expansion of non-invasive options available to patients. In 2024, the FDA approved the “Guardian Health Shield”, making the liquid biopsy the first blood test to approve colorectal cancer. It has now become part of the Precision oncology testing portfolio, which sold nearly $688 million last year, according to the company's annual report.
Precision Science will provide investor results for key research on its internally developed blood-based screening tests in the middle of this year. The company reported its second quarter financial results for 2025 on August 6, and the company revealed disappointing results. The company said the results showed a 73% sensitivity to colorectal cancer, 14% sensitivity to advanced precancerous lesions and a 90% specificity. Puneet Souda, an analyst at Leerink Partners, said in a study that the results are below the 74% sensitivity mark required for Medicare coverage, limiting its commercial potential.
Freenome said it recently submitted the last module it applied for before testing to the FDA, called SimpleScreen. The Brisbane, California-based company plans to submit supplements for its next-generation test to the agency after the final clinical verification date is available.
The agreement gives the U.S. exclusive rights to current and future versions of Freenome blood tests to indicate a single indication of colorectal cancer screening. Private Freenome has the right to include early detection tests for multiple cancers in development to screen for 10 cancers from a single patient blood sample.
Leerink's Souda said the deal was “a shot of Freenome's arm,” providing the company with cash and R&D partners while still allowing it to retain early detection rights for multiple cancers. But he added that after FDA approval, it is unlikely that precise science will be tested until the second half of 2026. This puts the Wisconsin company behind the Guardians about two years.
“Nevertheless, we believe [Exact Sciences’] The decision to work with Freenome will help validate their science and be motivated with other pipeline assays. ” Souda said.
Precision Science’s agreement with Freenome calls for advance payments in cash by November this year. This milestone includes $100 million for first-line approving first-page tests; $100 million for next-generation testing to meet specified performance benchmarks; $500 million if used as first-line A or B tests in the US Preventive Services Task Force (USPSTF) guidelines, or meet the coverage requirements of certain payer contracts.
Due to the profitability of the test and the provisions for reducing the royalty burden, the royalty due to FREENOME will be between 0% and 10%, so it will not make commercialization unprofitable. If certain unspecified criteria are not met, the agreement grants the right to exact scientific termination of the transaction. Exact Science also promised $20 million over the next three years to take advantage of joint R&D expenses for FreeNome technology.
Photos: Harmpeti, Getty Images
