The exact sciences associate with Freenome to take the health of the guards in colorectal cancer screening

A candidate for the colorectal blood test of the exact science cancer failed in his pivotal study, but the company is still in hunting to provide an alternative to liquid biopsy which was the first to market in this type of cancer and will do it with the help of a competitor. Exact Sciences acquire the rights of a Freenome test closer to the market than its faulty internal candidate.

Exact Sciences pays $ 75 million in advance for American rights at the Freenome blood test. Additional $ 700 million is linked to the realization of the milestones.

Madison, in the exact sciences of Wisconsin, is already well established in the screening of colorectal cancer with Cologuard et Co -CoLoguard Plus. Both are stool -based tests that force users to send a sample to a laboratory for cancer DNA detection. Even with the growth of the market of these tests, the screening field prompted to extend the non -invasive options available for patients. The approval of the FDA in 2024 of the Health Guardant shield made this liquid biopsy the first approved blood test for colorectal cancer. This is now part of a precision oncology test portfolio that generated nearly $ 688 million in sales last year, according to the company’s annual report.

The exact sciences had said that the results of investors of a central study of its internal blood testing test would be available in the middle of this year. On August 6, the same day that the company declared financial results in the second quarter of 2025, the company revealed disappointing results. The company said the results have shown 73% sensitivities for colorectal cancer and 14% for precancerous lesions advanced to 90% specificity. Leerink Partners’ analyst, Puneet Suddenly, said in a research note that these results are lower than the 74% sensitivity brand necessary for coverage of Medicare, which limits its commercial potential.

Freenome said that he had recently submitted to the FDA the last module of the pre-commercialization request for his test, which he calls SimproScreen. The company based in Brisbane, California, plans to submit to the agency an supplement for its new generation test once the final clinical validation dates are available.

The agreement gives the exact sciences of American rights exclusive to current and future versions of the Freenome blood test for the only indication of colorectal cancer screening. The private freeneoma has the right to include colorectal cancer screening for a multi-cancer early detection test, the development test for screening of more than 10 cancers of a single patient’s blood sample.

Suddenly Leerink said that the agreement is “a shot in the arm for Freenome”, providing the company in cash and a R&D partner while allowing it to keep the multi-cancer early detection rights. But he added that it is unlikely that the exact sciences will launch the Freenome test until the end of 2026, after approval of the FDA. This maintains the company of Wisconsin about two years behind the health of the guards.

“However, we believe [Exact Sciences’] The decision to collaborate with Freenome will help validate their science and is positive for their other pipeline tests, “said suddenly.

The terms of the agreement of the exact sciences with Freenome call for the initial payment to make in cash by November of this year. The milestones are made up of $ 100 million on front line approval for the first version of the test; 100 million dollars on the approval of the front -line FDA for the next generation test contingent on specified performance references; and $ 500 million if they are noted as a first-line A or B test in the employment services of the United States Preventive Services (USPSTF) or if it meets certain contract coverage requirements.

The royalties due to Freenome vary from 0% to 10%, depending on the profitability and the provisions of the test which reduce the burden of fees, which does not make marketing not profitable. If certain unpertified criteria are not met, the agreement gives the exact sciences the right to terminate the agreement. Exact Sciences also hired $ 20 million in the next three years in joint R&D expenses taking advantage of Freenome technology.

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