FDA批准Freenome血液结直肠癌筛查SimpleScreen CRC，Abbott将在美国独家商业化

The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S.
Abbott will pay Freenome $100 million as part of a 2025 deal covering the test’s U.S. commercialization in adults 45 and older who are at average risk for colorectal cancer.
Colorectal cancer incidence among people younger than 50 has been rising for decades. The disease remains one of the most common cancers and the second-leading cause of cancer-related death in the U.S.
A colonoscopy remains the gold standard for detecting the disease, alongside other visual exams, including CT colonography, sometimes called a virtual colonoscopy, and sigmoidoscopy. Current screening guidelines also include an annual fecal immunochemical test, or FIT, that can be completed at home and mailed to a laboratory.
A FIT looks for small amounts of blood in the stool. A positive result requires a follow-up colonoscopy. The test has relatively high sensitivity for colorectal cancer, although it is less effective at detecting advanced precancerous lesions.
The Freenome test is designed to reach people who may not undergo screening because they want to avoid a colonoscopy or do not want to complete a stool test.
Blood tests are not currently preferred screening options because they are less sensitive than established stool-based tests and visual exams, particularly for detecting precancerous growths. The American Cancer Society recommends blood-based screening only for people who decline or do not complete one of the preferred options.
With FDA approval, SimpleScreen CRC now “meet[s] the coverage criteria for Medicare and is expected to be incorporated into the American Cancer Society guidelines by name,” according to Freenome.
Up to 60 million Americans are overdue for recommended colorectal cancer screening, according to Freenome.
“The most effective screening test is the one a person will actually complete,” said Aasma Shaukat, M.D., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator of the study supporting the test’s approval, in a release.
“Many people who should be screened for colorectal cancer simply aren’t. A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes.”
Abbott, through its acquisition of Exact Sciences, currently markets the DNA stool test Cologuard and operates the digital healthcare platform Nexus. The platform supports noninvasive colorectal cancer screening by helping healthcare providers identify patients who are overdue for testing and could support the rollout of SimpleScreen.
SimpleScreen will compete against Guardant Health’s Shield blood test, which won FDA approval in 2024 for adults 45 and older who are at average risk for colorectal cancer.
SimpleScreen works by finding signals associated with colorectal cancer in cell-free DNA, or cfDNA, circulating in the blood.
Freenome said in the release that the test correctly detected about eight in 10 colorectal cancers while correctly producing negative results for nine in 10 people without colorectal cancer or advanced precancerous lesions.
In a prespecified analysis adjusted to match the age and sex distribution of the U.S. population, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions, which have a higher risk of developing into cancer, with 13.7% sensitivity. The test demonstrated 30.7% sensitivity for advanced precancerous lesions with high-grade dysplasia, which carry the greatest risk of progression, and 90.4% specificity for advanced colorectal neoplasia.