The U.S. Food and Drug Administration (FDA) has approved SimpleScreen CRC, a new blood-based screening option for colorectal cancer in adults aged 45 years and older who are at average risk for the disease. The test is produced by Freenome; Abbott will exclusively commercialize the test in the United States in fall 2026.
Colorectal cancer is the second-leading cause of cancer-related death in the United States, but it is highly preventable and treatable when detected early through screening. Up to 60 million Americans remain overdue for recommended screening, underscoring the need for additional convenient screening approaches that can help reach more people.
SimpleScreen CRC detects signals associated with colorectal cancer from cell-free DNA (cfDNA) in the blood. The FDA approval reflects years of clinical research; artificial intelligence/machine learning–driven technology development; and extensive collaboration with investigators, health-care providers, and partners.
“The most effective screening test is the one a person will actually complete,” said Aasma Shaukat, MD, MPH, Professor of Medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study. “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.”
PREEMPT CRC
SimpleScreen CRC was evaluated in PREEMPT CRC, the largest prospective clinical validation study ever conducted for a blood-based colorectal cancer screening test. Conducted at over 200 sites, PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 years who were scheduled for a screening colonoscopy. In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity, including 30.7% for advanced precancerous lesions with high-grade dysplasia. The test showed 90.4% specificity for advanced colorectal neoplasia. In practical terms, the test correctly detected about 8 in 10 colorectal cancers while correctly producing negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.
“The fact is that 90% of colorectal cancer deaths are preventable, yet the disease will still claim more than 55,000 lives in the U.S. this year alone,” added Anjee Davis, MPAA, Chief Executive Officer of Fight Colorectal Cancer. “Regular screening is the key to reversing that trend, and new, minimally invasive screening options that help more people get screened are a critical part of that process. Colorectal cancer is increasingly affecting younger adults, and a screening test that fits into a routine visit, accompanied by prompt follow-up in response to an abnormal result, can play an important role in driving earlier treatment and prevention.”
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare and is expected to be incorporated into the American Cancer Society guidelines.
The test is indicated for adults aged 45 years and older who are at average risk for colorectal cancer and referred by a health-care provider for colorectal cancer screening. A positive result indicates a signal was detected that may suggest the presence of colorectal cancer or advanced precancerous lesions and should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
