The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio. This expansion of Abbott’s portfolio shows the company’s commitment to providing a range of screening options for patients.
Market Competition
SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.” The presence of multiple screening tests on the market may lead to increased competition, driving innovation and potentially improving patient outcomes.
Both SimpleScreen and Shield are approved for adults 45 and older who are at average risk for colorectal cancer. As many as 60 million Americans are overdue for recommended screening, according to Freenome. This significant screening gap highlights the need for convenient and accessible screening methods, which SimpleScreen and Shield aim to address.
Screening Gap
While colonoscopy is the gold standard for colorectal cancer detection, the screening gap illustrates the need for more convenient approaches, the company said. The TD Cowen analysts said they expect Abbott to prioritize Cologuard, which offers better performance than both SimpleScreen and Guardant’s blood-based test. This prioritization may influence how Abbott markets SimpleScreen, potentially positioning it as an alternative for patients who are unwilling or unable to undergo colonoscopy or use stool-based tests.
Freenome retains U.S. rights to commercialize the current SimpleScreen test and future versions as part of a multicancer early detection offering, the TD Cowen analysts said. SimpleScreen detects cancer signals from cell-free DNA in the blood. This technology has the potential to enable early detection of colorectal cancer, which is critical for improving treatment outcomes and patient survival rates.
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The company, which went public earlier this month, will receive a $100 million milestone payment from Abbott as a result of the FDA approval, under a commercial agreement the partners inked in August 2025. The FDA approval is based on the PREEMPT CRC study of more than 48,000 people that detected about 8 in 10 colorectal cancers.
In the FDA approval process, the test also correctly provided negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions. This approval may lead to increased screening rates, as it provides an alternative to traditional colonoscopy methods. Furthermore, the accuracy of SimpleScreen in detecting cancer signals from cell-free DNA in the blood may help reduce the number of false positives and false negatives, which can be a significant concern in cancer screening.
As the market for colorectal cancer screening continues to evolve, it’s likely that multiple tests will coexist, each with their own strengths and weaknesses. The SimpleScreen test, with its ability to detect cancer signals from cell-free DNA in the blood, may become a valuable tool in the fight against colorectal cancer. The collaboration between Abbott and Freenome demonstrates the potential for partnerships to drive innovation and improve patient outcomes in the field of cancer screening.
The PREEMPT CRC study, which formed the basis of the FDA approval, highlights the importance of large-scale clinical trials in validating the effectiveness of cancer screening tests. The study’s findings demonstrate the potential of SimpleScreen to detect colorectal cancer in its early stages, which is critical for improving treatment outcomes and patient survival rates. As the use of SimpleScreen becomes more widespread, it will be important to continue monitoring its performance and comparing it to other screening methods to ensure that patients receive the best possible care.
The fact that Freenome retains U.S. rights to commercialize the current SimpleScreen test and future versions as part of a multicancer early detection offering suggests that the company is committed to continuing innovation in the field of cancer screening. This may involve developing new tests or improving existing ones, which could lead to further advancements in the detection and treatment of colorectal cancer and other types of cancer.