Freenome has published results from the pivotal PREEMPT CRC study in JAMA, marking a significant milestone in colorectal cancer screening with the largest prospective study of a blood-based test involving 48,995 average-risk adults aged 45 to 85. The study met all prespecified primary acceptance criteria and surpassed CMS coverage requirements for sensitivity and specificity in the intended use population.
Study Design and Population
PREEMPT CRC (NCT04369053) was conducted at more than 200 clinical sites using a hybrid recruitment strategy designed to increase trial accessibility and diversity. The study enrolled participants from every state in the continental U.S., with more than 11% identifying as Black or African American and over 11% as Hispanic or Latino. All participants underwent a routine colonoscopy following a blood draw.
Based on data from 27,010 eligible participants who enrolled consecutively after a predetermined cut-off date agreed upon with the FDA to account for the COVID-19 pandemic period, the test demonstrated strong performance across key metrics. The publication includes a pre-specified analysis that weighted test performance to match the sex and age distribution of the U.S. population, following FDA methodology used for other CRC screening products.
Performance in Younger Adults
The test showed particularly promising results in adults aged 45-49, a newly recommended screening population with only 20% compliance rates. In this critical demographic, the test achieved 100% sensitivity for colorectal cancer and 94.8% specificity for advanced colorectal neoplasia (ACN) in the primary analysis.
"Despite clear guidelines, many communities still face barriers that lead to fewer people getting screened for colorectal cancer," said Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and co-lead principal investigator on the PREEMPT CRC study. "The study's rigor and scale provide confidence in the test's performance. Its high sensitivity means it can detect most cancers, while high specificity helps avoid false alarms."
Technology Platform
Freenome's test is built on a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers to detect cancer-specific signals in the bloodstream, including those derived from circulating tumor DNA (ctDNA). The test applies an AI/ML-based model to detect specific methylation signatures in ctDNA at a base level and is designed for use with a standard blood draw, integrating into routine clinical workflows.
"By enrolling a diverse, average-risk population and analyzing samples consecutively, the PREEMPT study mirrored real-world use," said Aaron Elliott, Ph.D., chief executive officer at Freenome. "The test showed strong performance in Stage I cancer and high-risk pre-cancers and among younger adults, compared to FDA-approved CRC blood tests."
Addressing Screening Barriers
More than two out of five U.S. adults of screening age are not current with recommended CRC screening, with barriers such as discomfort, preparation requirements, and access issues contributing to low adoption rates. The blood-based test offers a potential solution to these challenges.
"We need more tools that meet people where they are, which includes offering noninvasive screening options that are simple to complete," Dr. Shaukat added. "This test has the potential to increase screening uptake, especially among people who might otherwise delay or avoid screening."
Regulatory Timeline and Future Development
Freenome is advancing its premarket approval submission to the FDA, with all modules expected to be completed by mid-2025. The company continues to advance a test versioning strategy focused on assay and algorithm improvements to enhance CRC and advanced precancerous lesion detection, as well as pursue expansion into additional indications, including lung cancer.
The study's diverse partnership network included the Colorectal Cancer Alliance, Dia de la Mujer Latina, the Intercultural Center for Health Research and Wellness, historically Black colleges and universities including Morehouse School of Medicine, and CVS Health Clinical Trial Services for coordinated enrollment efforts.
