ctDNA Blood Test Detected 79% of Colorectal Cancers in Screening Study: Daily Dose

_{©New Africa/AdobeStock}

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On June 3, 2025, we reported on a study published in JAMA that was designed to examine the clinical performance of an investigational blood-based circulating tumor DNA test for colorectal cancer (CRC) detection in an average-risk population.

The study

The study enrolled asymptomatic adults aged 45 to 85 years at average risk for CRC between May 2020 and April 2022 across 201 centers in the US and the United Arab Emirates. Study inclusion required participants to complete a standard of care screening colonoscopy and laboratory testing.

Study staff and pathologists and participants were blinded to to results of blood tests, and laboratory studies were performed blinded to findings on colonoscopy. The primary outcomes included sensitivity for CRC, specificity for advanced colorectal neoplasia, and both positive and negative predictive values. As a secondary endpoint, investigators evaluated sensitivity for advanced precancerous lesions.

The mean age among the 27 010 participants in the evaluable cohort was 57 years and half (55.8%) were women.

The findings

The blood-based ctDNA test demonstrated a sensitivity of 79.2% (95% CI, 68.4% - 86.9%) for detecting CRC and a specificity of 91.5% (95% CI, 91.2% - 91.9%) for advanced colorectal neoplasia. The investigational test had a negative predictive value of 90.8% (95% CI, 90.7% - 90.9%) and a positive predictive value of 15.5% (95% CI, 14.2% - 16.8%) for advanced colorectal neoplasia.

All primary endpoints met the prespecified acceptance criteria. However, the test’s sensitivity for advanced precancerous lesions was 12.5% (95% CI, 11.3% to 13.8%) falling short of the predefined threshold.

Authors' comments

"In an average-risk colorectal cancer screening population, a blood-based test demonstrated acceptable accuracy for colorectal cancer detection, but detection of advanced precancerous lesions remains a challenge, and ongoing efforts are needed to improve test sensitivity."

Click here for more details.