A colorectal most cancers blood take a look at candidate from Precise Sciences fell quick in its pivotal research, however the firm remains to be within the hunt to offer a substitute for the liquid biopsy that was first to market in one of these most cancers and can accomplish that with assist from a competitor. Precise Sciences is buying rights to a take a look at from Freenome that’s nearer to the market than its failed inside candidate was.
Precise Sciences is paying $75 million up entrance for U.S. rights to Freenome’s blood take a look at. One other $700 million is tied to the achievement of milestones.
Madison, Wisconsin-based Precise Sciences is already nicely established in colorectal most cancers screening with Cologuard and Cologuard Plus. Each are stool-based exams that require customers to ship a pattern to a lab for detection of most cancers DNA. Even with the market development of those exams, the screening area has been pushing to develop the non-invasive choices accessible to sufferers. The 2024 FDA approval of Guardant Well being’s Protect made that liquid biopsy the primary blood take a look at authorized for colorectal most cancers. It’s now a part of a precision oncology testing portfolio that generated almost $688 million in gross sales final 12 months, in line with the corporate’s annual report.
Precise Sciences had been telling buyers outcomes from a pivotal research of its internally developed blood-based screening take a look at could be accessible in the course of this 12 months. On Aug. 6, the identical day the corporate reported second quarter 2025 monetary outcomes, the corporate disclosed outcomes that had been disappointing. The corporate mentioned outcomes confirmed sensitivities of 73% for colorectal most cancers and 14% for superior precancerous lesions at 90% specificity. Leerink Companions analyst Puneet Souda mentioned in a analysis observe that these outcomes are under the 74% sensitivity mark wanted for Medicare protection, which limits its industrial potential.
Freenome mentioned it lately submitted to the FDA the final module of the pre-market utility for its take a look at, which it calls SimpleScreen. The Brisbane, California-based firm plans to undergo the company a complement for its next-generation take a look at as soon as remaining medical validation dates can be found.
The settlement give Precise Sciences unique U.S. rights to present and future variations of Freenome’s blood take a look at for the only indication of colorectal most cancers screening. Privately held Freenome has the precise to incorporate colorectal most cancers screening in a multi-cancer early detection take a look at at present in improvement for screening greater than 10 cancers from a single pattern of affected person blood.
Leerink’s Souda mentioned the deal is “a shot within the arm for Freenome,” offering the corporate with money and an R&D accomplice whereas nonetheless enabling it to retain multi-cancer early detection rights. However he added that Precise Sciences is unlikely to launch Freenome’s take a look at till late 2026, following FDA approval. That retains the Wisconsin firm about two years behind Guardant Well being.
“Nonetheless, we imagine (Precise Sciences’) resolution to collaborate with Freenome will assist validate their science, and is constructive for his or her different pipeline assays,” Souda mentioned.
The phrases of Precise Sciences’ cope with Freenome name for the upfront fee to be made in money by November of this 12 months. The milestones encompass $100 million upon first-line approval for the primary model of the take a look at; $100 million upon first-line FDA approval for the next-generation take a look at contingent on hitting specified efficiency benchmarks; and $500 million if rated as a first-line A or B take a look at in the USA Preventive Companies Taskforce (USPSTF) tips or if it meets sure payer contracted protection necessities.
Royalties resulting from Freenome will vary from 0% to 10%, relying on the take a look at’s profitability and provisions that cut back the royalty burden so it doesn’t make commercialization unprofitable. If sure unspecified standards usually are not met, the settlement offers Precise Sciences the precise to terminate the deal. Precise Sciences has additionally dedicated $20 million over the subsequent three years in joint R&D bills leveraging the Freenome know-how.
Photograph: harmpeti, Getty Pictures
