NCCN Adds 2 Tests to CRC Screening Guidelines

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The National Comprehensive Cancer Network (NCCN) has updated its Guidelines for Colorectal Cancer (CRC) Screening to include both the ColoSense test and the Shield blood test.1-3

ColoSense Background

ColoSense is a noninvasive stool-based test intended to detect CRC and advanced adenomas in average-risk patients 45 years of age and older.1 In May 2024, the FDA approved ColoSense as a screening test for adults 45 years of age or older who are at typical average risk for developing CRC.4

“The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,” Erica Barnell, MD, PhD, chief science and medical officer of Geneoscopy, stated in a news release.1 “As the first and only FDA-approved stool RNA screening test for CRC, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.”

Findings from the CRC-PREVENT trial (NCT04739722) showed that among 8920 participants 45 years of age or older who used ColoSense, the test’s sensitivity for CRC detection was 94%, including 100% for stage I CRC.5 Advanced adenomas were detected at a sensitivity of 46%; this rate was 50% for advanced adenomas over 2 cm. The CRC and advanced adenoma sensitivity rates in patients 45 to 49 years of age were 100% and 45%, respectively.

“The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,” Matt Sargent, chief commercial officer of Geneoscopy, added in the news release.1 “Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN Guideline inclusion also positions ColoSense for future inclusion in other major guidelines.”

Shield Background

The Shield blood test is designed to detect CRC signals in the bloodstream from circulating tumor DNA; like ColoSense, the NCCN CRC Screening Guidelines call for patients using the Shield test to be tested every 3 years.2,3 In July 2024, the FDA approved Shield for CRC screening in adults 45 years of age and older who are at average risk for developing the disease.6 Notably, the Guidelines recommend Shield only for patients who are not willing to undergo screening through another modality, due to "its modest performance, particularly among advanced precancerous lesions."3

“With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of eligible Americans who are forgoing their recommended screening for CRC,” AmirAli Talasaz, co-chief executive officer of Guardant Health, stated in another news release.2 “This major guideline inclusion from the NCCN is just the first for Shield, and we believe a pivotal step for more patients to benefit from this test.”

In the observational ECLIPSE trial (NCT04136002), Shield was tested in a clinical validation cohort that featured 10,258 participants; 7861 participants from this group were evaluable for the study.7 Patients needed to be 45 to 84 years of age, at average risk for CRC, and slated to undergo screening with colonoscopy.

Among patients with CRC detected by colonoscopy, the ctDNA sensitivity rate of Shield was 83.1% (95% CI, 72.2%-90.3%). The sensitivity rate for stage I to III disease was 87.5% (95% CI, 75.3%-94.1%). The sensitivity rate for advanced precancerous lesions was 13.2% (95% CI, 11.3%-15.3%).

Additionally, among patients who did not have CRC or advanced precancerous lesions detected on colonoscopy, the specificity rate for any advanced neoplasia was 89.6% (95% CI, 88.8%-90.3%). The specificity for a negative colonoscopy was 89.9% (95% CI, 89.0%-90.7%).

References

1. Geneoscopy’s RNA-based ColoSense test included in latest National Comprehensive Cancer Network (NCCN) Guidelines. News release. Geneoscopy. June 3, 2025. Accessed June 3, 2025. https://www.geneoscopy.com/geneoscopys-rna-based-colosense-test-included-in-latest-national-comprehensive-cancer-network-nccn-guidelines/
2. National Comprehensive Cancer Network (NCCN) updates Colorectal Cancer Screening Guidelines to include Shield blood-based screening. News release. Guardant Health. June 2, 2025. Accessed June 3, 2025. https://investors.guardanthealth.com/press-releases/press-releases/2025/National-Comprehensive-Cancer-Network-NCCN-Updates-Colorectal-Cancer-Screening-Guidelines-to-Include-Shield-Blood-Based-Screening/default.aspx
3. Colorectal cancer screening. NCCN. May 30, 2025. Accessed June 3, 2025. https://www.nccn.org/professionals/physician_gls/pdf/colorectal_screening.pdf
4. FDA approves ColoSense - Geneoscopy’s noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test. News release. Geneoscopy. May 6, 2024. Accessed June 3, 2025. https://www.geneoscopy.com/fda-approves-colosense-geneoscopys-noninvasive-multi-target-stool-rna-mtrna-colorectal-cancer-screening-test/
5. JAMA publishes Geneoscopy’s pivotal CRC-PREVENT trial results, reporting highest sensitivity for detecting colorectal cancer and advanced adenomas among available noninvasive screening tests. News release. October 23, 2023. Accessed June 3, 2025. https://www.geneoscopy.com/jama-publishes-geneoscopys-pivotal-crc-prevent-trial-results-reporting-highest-sensitivity-for-detecting-colorectal-cancer-and-advanced-adenomas-among-available-noninvasive-screening-tests/
6. Guardant Health’s Shield blood test approved by FDA as a primary screening option, clearing path for Medicare reimbursement and a new era of colorectal cancer screening. News release. Guardant Health. July 29, 2024. Accessed June 3, 2025. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-Shield-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening/default.aspx
7. Chung DC, Gray DM 2nd, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390(11):973-983. doi:10.1056/NEJMoa2304714