The FDA has approved SimpleScreen CRC, a blood-based screening test for colorectal cancer (CRC), for use in adults 45 years of age and older who are at average risk for the disease.1
The approval was supported by data from PREEMPT CRC (NCT04369053), a prospective, observational clinical validation study described as the largest ever conducted for a blood-based CRC screening test, according to Freenome, the developer of SimpleScreen CRC.
In a prespecified analysis adjusted to match the US Census, SimpleScreen CRC detected CRC with 81.1% sensitivity and advanced precancerous lesions (APLs) with 13.7% sensitivity, including 30.7% sensitivity for APLs with high-grade dysplasia; specificity for advanced colorectal neoplasia was 90.4%.
“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, in the news release. “Many people who should be screened for CRC 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.”
CRC is the second-leading cause of cancer-related death in the US, although it is highly preventable and treatable when detected early through screening. Up to 60 million Americans remain overdue for recommended screening, according to the news release, underscoring the need for additional screening approaches that can reach more eligible adults.
SimpleScreen CRC is indicated for adults 45 years of age and older who are at average risk for CRC and are referred by a health care provider for screening. A positive result indicates that a signal was detected that may suggest the presence of CRC or APLs and should be followed by colonoscopy. The test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
SimpleScreen CRC detects signals associated with CRC from cell-free DNA (cfDNA) in the blood using a single blood draw. The test is built on Freenome’s multiomics platform, which analyzes cfDNA methylation patterns at single-base resolution alongside additional biomarkers, incorporating AI/ML-driven technology development.
PREEMPT CRC was conducted at more than 200 sites and enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 years of age who were scheduled for a screening colonoscopy.1,2
The prospective design compared test results against colonoscopy findings across the enrolled population. Detailed validation results for the assay were published in JAMA.3
The study did not include participants who had a history of CRC or colorectal adenoma; who had inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease; who underwent colonoscopy in the 9 years preceding enrollment; who had stool DNA testing in the 2 years preceding enrollment; or who had Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation.2
All enrolled patients underwent blood collection and a standard-of-care colonoscopy.
Sensitivity for CRC, advanced colorectal neoplasia, along with positive/negativie predicitive values, served as the trial’s primary end points.
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare and is expected to be incorporated by name into the American Cancer Society colorectal cancer screening guidelines, milestones the companies said would help expand access to blood-based CRC screening for eligible adults.1
Abbott will exclusively commercialize the test in the US, building on the provider relationships, reimbursement expertise, and patient support programs it has developed through Cologuard, including its Nexus platform.
