US EditionFreenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer
- On June 2, 2025, in Brisbane, California, Freenome reported the release of comprehensive findings from the key PREEMPT CRC trial in the journal JAMA.
- Launched in 2020, the study recruited nearly 49,000 average-risk individuals without symptoms, ranging in age from 45 through 85, across more than 200 locations, employing a combined virtual and in-person approach to promote diversity and broad representation.
- PREEMPT CRC met all primary efficacy endpoints, demonstrating 79.2% colorectal cancer sensitivity, 91.5% specificity for advanced neoplasia, but only 12.5% sensitivity for advanced precancers, with strong performance in early-stage cancer and younger adults.
- Aaron Elliott, CEO of Freenome, emphasized that the PREEMPT study was designed to reflect practical clinical settings by including a varied group of average-risk individuals and processing samples in a continuous manner. Meanwhile, Dr. Aasma Shaukat pointed out that many communities still encounter obstacles that prevent widespread colorectal cancer screening.
- Freenome is progressing with its FDA premarket approval submission, aiming to complete all required components by mid-2025, and its test may encourage more individuals, particularly those who typically postpone or skip screening, to participate in colorectal cancer screening.
16 Articles
16 Articles
Blood-based screening has acceptable accuracy for colorectal cancer detection
A blood-based test has acceptable accuracy for colorectal cancer detection but not for advanced precancerous lesions in an average-risk colorectal cancer screening population, according to a study published online June 2 in the Journal of the American Medical Association.
Aspen Daily News
Freenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer
– PREEMPT CRC, the largest prospective study of its kind, met all primary efficacy endpoints and surpassed CMS coverage requirements for sensitivity and specificity in the intended use population –
Blood-Based Screening Shows Mixed Results for Colorectal Cancer
An investigational, blood-based test for circulating tumor DNA shows “reasonable accuracy” for detecting colorectal cancer (CRC) among people at average risk, researchers report, but its ability to reveal early-stage lesions presents more of a challenge. The clinical validation results of the PREEMPT CRC study, reported in JAMA, suggest further improvements are needed for it to replace traditional colonoscopy and stool-based screening. In an edi…
Coverage Details
Bias Distribution
- 80% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
