Blood-based test could increase adherence to colorectal cancer screening
Key takeaways:
- A blood-based test demonstrated high sensitivity for colorectal cancer among individuals with average risk.
- The test also had a high specificity for advanced colorectal neoplasia.
An investigational blood-based test identified nearly 80% of individuals who had colorectal cancer, according to results of a large prospective trial presented at ASCO Gastrointestinal Cancers Symposium.
The test also had a specificity greater than 90% for advanced colorectal neoplasia (ACN) and negative-predictive value for ACN.
“This new blood test may provide a convenient, effective option for colorectal cancer screening in the intended-use population, and perhaps help us boost adherence to screening,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, said during a press briefing.
Background and methods
Colorectal cancer incidence is increasing and is projected to be the second leading cause of cancer mortality in the U.S. this year, according to American Cancer Society’s Cancer Statistics 2025 report.
However, only 59% of individuals eligible for screening are up to date, according to study background.
“Blood-based tests can provide another modality for colorectal cancer screening, allowing us to improve adherence beyond what’s offered with colonoscopy and current stool-based tests,” Shaukat said.
Shaukat and colleagues conducted the PREEMPT CRC trial to evaluate a blood-based test for individuals aged 45 to 85 years at average risk for colorectal cancer and eligible for screening. Study participants had no history of cancer, colorectal adenoma or inflammatory bowel disease, nor any family history of colorectal cancer.
The cohort included 27,010 participants (32.3% aged 55 to 65 years; 51.8% women).
Sensitivity for colorectal cancer, as well as specificity, negative-predictive value and positive-predictive value for CAN, served as primary endpoints.
Sensitivity for advanced precancerous lesions served as a secondary endpoint.
Results
Overall, 72 trial participants had colorectal cancer, 2,567 had advanced precancerous lesions, 7,270 had nonadvanced precancerous lesions and 17,101 had negative findings.
The blood-based test had a 79.2% sensitivity for colorectal cancer, 91.5% specificity for ACN, 90.8% negative predictive value for ACN, 15.5% positive predictive value for ACN, and 12.5% sensitivity for advanced precancerous lesions.
After adjusting for U.S. census data on age and sex, researchers found the blood-based test had similar sensitivity and specificity results.
“The study met all its primary endpoints,” Shaukat said, describing the results as “robust.”
However, “the sensitivity for colorectal cancer and advanced precancerous lesions was lower than expected, and we hope it will continue to be optimized in future research and development,” she added.
Future studies can investigate test performance, colorectal cancer progression, adherence and cost, Shaukat said.
‘Another tool’
ASCO expert Pamela L. Kunz, MD, director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and Yale Cancer Center, as well as chief of gastrointestinal medical oncology at Yale School of Medicine, described the test as “another tool [in our] tool kit.”
“We all know that there are barriers to colorectal cancer screening, and adherence with colorectal cancer screening could certainly improve,” Kunz, who was not involved in the study, said during the press briefing. “Any screening is better than no screening.
“I’m eager to see some of the future work of optimizing the sensitivity,” she added. “I also look forward to seeing subsequent analyses that look at differences by race and ethnicity.”
Kunz also said the test results “are not as strong” compared with Guardant Health’s Shield, the first FDA-approved blood test for primary colorectal cancer.
“These are early data, so I look forward to seeing some of their future results. But at present, the test characteristics in terms of sensitivity and specificity are better with the Guardant test,” Kunz said.
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Shaukat A, et al. Abstract 18. Presented at: ASCO Gastrointestinal Cancers Symposium; Jan. 23-25, 2025; San Francisco.