‘Shield’ Blood-Based Colorectal Cancer Screening Test Included in NCCN Guidelines — Korean Launch Expected in 2025

Shield, a blood-based colorectal cancer screening test developed by precision oncology company Guardant Health, has been officially included in the 2025 Colorectal Cancer Screening Guidelines by the National Comprehensive Cancer Network (NCCN) — the first blood-based test ever to be listed in these guidelines.

Shield analyzes tumor-derived DNA signals in the blood to non-invasively assess the risk of colorectal cancer, requiring only a simple blood draw during an outpatient visit, minimizing patient burden.

The NCCN now recommends that adults aged 45 and older—considered at elevated risk for colorectal cancer—undergo the Shield test once every three years.

This update was based on results from the large-scale U.S. clinical study known as the ECLIPSE trial, which enrolled approximately 10,000 participants. Published in the New England Journal of Medicine (NEJM), the study demonstrated that Shield achieved 83% sensitivity in detecting colorectal cancer. Notably, patient adherence exceeded 90%, even among those who were unwilling to undergo colonoscopy or stool-based screening, positioning Shield as a highly accessible alternative to existing methods.

Shield received official FDA approval in July 2024, confirming both its clinical efficacy and safety. Its ability to engage populations that avoid traditional colonoscopy or stool testing was a key factor in its inclusion in the NCCN guidelines.

AmirAli Talasaz, Co-CEO of Guardant Health, stated:

“Shield offers a highly accessible alternative for individuals who have avoided traditional colorectal cancer screening. Its inclusion in the NCCN guidelines marks a significant milestone in validating the clinical value of Shield and signals a paradigm shift in cancer screening.”

 

In Korea, Dow Biomedica, the official distributor of Shield, announced that it plans to begin offering the test in August 2025 through international referral testing. The test will be ordered through domestic medical institutions, with samples sent to certified laboratories in the U.S. for analysis.

A Dow Biomedica representative commented:

“Beyond its high accuracy, Shield holds strategic value in encouraging screening among individuals reluctant to participate in conventional programs. Given Korea’s low colorectal cancer screening rates, we believe this simple blood test could offer a new motivation for broader participation.”