A colorectal cancer blood test candidate from Exact Sciences didn’t perform as hoped in its pivotal study, but the company isn’t out of the running. Instead, Exact Sciences is acquiring rights to a blood test from Freenome that’s closer to market entry, signaling a strategic shift in its pursuit of non-invasive screening options.
Exact Sciences Secures U.S. Rights to Freenome’s Colorectal Cancer Blood Test
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Exact Sciences is paying $75 million upfront for rights to Freenome’s test, with an additional $700 million contingent on milestones.
Madison, Wisconsin-based Exact Sciences, already a major player in colorectal cancer screening with its stool-based Cologuard and Cologuard Plus tests, is deepening its commitment to non-invasive options. The company is licensing a blood-based screening test from Brisbane, California-based Freenome, a move that comes after its own internally developed blood test showed disappointing results. These results, disclosed on Aug. 6, revealed sensitivities of 73% for colorectal cancer and 14% for advanced precancerous lesions at 90% specificity. Analysts noted these figures fall below the 74% sensitivity threshold often required for Medicare coverage, potentially limiting commercial viability.
What’s the significance of this deal for colorectal cancer screening? This collaboration aims to bring a new blood-based screening option to market, potentially complementing existing stool-based tests and offering patients more choices.
The U.S. market for blood tests for colorectal cancer screening saw its first FDA-approved liquid biopsy in 2024 with Guardant Health’s Shield. That test is part of a portfolio that generated nearly $688 million in sales last year.
Freenome’s SimpleScreen Nears Regulatory Review
Freenome has recently submitted the final module of its pre-market application to the FDA for its test, named SimpleScreen. The company also plans to submit a supplement for its next-generation test once final clinical validation data is available. The agreement grants Exact Sciences exclusive U.S. rights to both current and future versions of Freenome’s blood test specifically for colorectal cancer screening. Freenome retains the right to incorporate colorectal cancer screening into its broader multi-cancer early detection test, which aims to screen for more than 10 cancers from a single blood sample.
Strategic Deal Bolsters Freenome, Positions Exact Sciences
Analysts view the deal as a significant boost for Freenome, providing essential funding and an R&D partner while allowing it to maintain its multi-cancer detection ambitions. However, it’s anticipated that Exact Sciences might not launch Freenome’s test until late 2026, following FDA approval. This timeline places the Wisconsin company roughly two years behind Guardant Health in the market.
“Still, we believe [Exact Sciences’] decision to collaborate with Freenome will help validate their science, and is positive for their other pipeline assays,” an analyst noted.
Financial Terms and Future Milestones
The financial terms of the agreement include an upfront payment of $75 million, due by November of this year. An additional $700 million is tied to performance milestones. These include $100 million upon first-line FDA approval for the initial version of the test, another $100 million for first-line FDA approval of the next-generation test if performance benchmarks are met, and $500 million if the test achieves a first-line A or B rating in United States Preventive Services Taskforce (USPSTF) guidelines or meets specific payer coverage requirements. Royalties to Freenome will range from 0% to 10%, structured to ensure commercial viability. Exact Sciences has also committed $20 million over the next three years for joint R&D efforts utilizing Freenome’s technology.
