The Food and Drug Administration approved SimpleScreen CRC, a blood-based colorectal cancer screening test developed by Freenome, on July 27, 2026. Abbott will commercialize it in the United States this fall.
The test is cleared for adults age 45 and older at average risk. That means people with no personal history of colorectal cancer, advanced polyps or inflammatory bowel disease, and no strong family history of the disease.
A positive result is not a diagnosis. According to the Cancer Network, a positive result should be followed by a colonoscopy, and the blood test is not meant to replace diagnostic or surveillance colonoscopy in higher-risk patients.
What the pivotal study showed
Approval was based on the PREEMPT CRC study, which enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 across over 200 sites.
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In a prespecified analysis adjusted to the U.S. Census, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and had 90.4% specificity for advanced colorectal neoplasia.
It also caught 30.7% of the most worrisome precancerous polyps, those with high-grade dysplasia, but only 13.7% of advanced precancerous lesions overall.
Blood tests are strong at catching cancer once it is present, but weaker at flagging the polyps a colonoscopy can remove before they turn into cancer. A stool-based test or a colonoscopy still finds more precancerous growths.
Why a blood test could move the needle
Colorectal cancer is the second-leading cause of cancer death in the United States, and Freenome estimates as many as 60 million Americans are behind on screening.
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Many people skip colonoscopy because of the prep, the sedation or the time off work, and stool-based tests are often left in the bathroom.
The idea behind an in-office blood draw is to reach people who would otherwise stay unscreened, which is linked to worse outcomes when cancer is eventually found.
The U.S. Preventive Services Task Force recommends screening begin at age 45 for adults at average risk, following a rise in cases in younger adults.
Colonoscopy, stool DNA tests such as Cologuard, and fecal immunochemical tests are the current mainstays, and the starting age was lowered from 50 in 2021.
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Where SimpleScreen CRC fits
The test is meant to complement, not replace, those options. Doctors are expected to offer it primarily to patients who have refused other forms of screening, and any positive result triggers a colonoscopy.
SimpleScreen CRC meets Medicare's coverage criteria for blood-based colorectal cancer screening tests. Abbott has said the launch is planned for fall 2026.
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This article is made and published by Ida-Marie Palm Varbæk, who may have used AI in the preparation.