Blood-based test detects CRC with 83% sensitivity, ‘could help overcome’ screening barriers
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Key takeaways:
- The blood-based test identified stage I, II or III colorectal cancers with a sensitivity of 87.5%.
- The test’s sensitivity for advanced precancerous lesions was 13.2%.
A cell-free DNA blood-based test detected colorectal cancer with a sensitivity of 83% and a specificity of 90% for advanced neoplasia in an average-risk population, according to new data published in The New England Journal of Medicine.
“More than three out of four Americans who die from colorectal cancer are not up to date with their recommended screening, highlighting the need for a more convenient and less invasive screening method that can overcome barriers associated with traditional options,” Daniel Chung, MD, medical co-director at the Center for Cancer Risk Assessment and director at the High-Risk GI Cancer Clinic at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a related press release. “The ECLIPSE study results published [March 13, 2024] support the use of a blood test as a screening option that could help overcome these barriers and improve CRC screening rates.”
The prospective, observational ECLIPSE study, conducted at 265 U.S. sites, assessed the performance characteristics of a cell-free DNA (cfDNA) blood-based test (Shield, Guardant Health) among 7,861 adults aged 45 to 84 years (mean age, 60 years; 53.7% women) at average-risk for CRC and undergoing routine screening with colonoscopy.
Coprimary outcomes were sensitivity for CRC and specificity for advanced neoplasia compared with screening colonoscopy. The secondary outcome was sensitivity for detection of advanced precancerous lesions.
According to results, 83.1% of participants with colonoscopy-detected CRC had a positive cfDNA test and 16.9% had a negative test, demonstrating a sensitivity of 83.1% (95% CI, 72.2-90.3) for the test’s detection of CRC.
In addition, the cfDNA blood-based test identified 42 of 48 stage I, II or III CRCs with a sensitivity of 87.5% (95% CI, 95% CI, 75.3-94.1), including 11 of 17 stage I CRCs with a sensitivity of 65% (95% CI, 41-83). Stages II and III CRCs were detected with 100% (95% CI, 78-100) and 100% (95% CI, 82-100) sensitivities, respectively, as were stage IV CRCs (100%; 95% CI, 72-100). The sensitivity for the detection of advanced precancerous lesions was 13.2% (95% CI, 11.3-15.3).
Further, 89.6% of participants without any advanced colorectal neoplasia at colonoscopy had a negative cfDNA test, indicating a specificity for advanced neoplasia of 89.6% (95% CI, 88.8-90.3). The specificity for negative colonoscopy was 89.9% (95% CI, 89.0 to 90.7).
“The results of the study are a promising step toward developing more convenient tools to detect colorectal cancer early while it is more easily treated,” study author William M. Grady, MD, medical director of the gastrointestinal cancer prevention program and professor at Fred Hutchinson Cancer Center, said in the release. “The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options.”
Reference:
- Guardant Health ECLIPSE study data demonstrating efficacy of Shield blood-based test for colorectal cancer screening published in The New England Journal of Medicine. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-ECLIPSE-Study-Data-Demonstrating-Efficacy-of-Shield-Blood-based-Test-for-Colorectal-Cancer-Screening-to-be-Published-in-The-New-England-Journal-of-Medicine/default.aspx. Published March 13, 2024. Accessed March 14, 2024.
Perspective
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Emanuela S. Alvarenga, MD
In a scenario in which CRC screening rates remain suboptimal despite multiple screening modalities available, an extra tool in the arsenal for earlier detection must be embraced.
This study reports overall CRC detection rates that are comparable to those with the most commonly used stool tests.
What is particularly important in this study is that the sensitivity of the cfDNA blood-based test for identification of stage I CRC was 55% and 65% for clinical and pathology-confirmed CRC, respectively.
The test intended to be complementary to — not a replacement for — current recommended CRC screening methods.
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