On September 4, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a positive clinical readout update assessing the performance of the latest colorectal cancer (CRC) screening algorithm (V2) for its Shield blood test (Press release, Guardant Health, SEP 4, 2025, View Source [SID1234655783]). The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity. Sensitivity for detection of stage I CRC was 62%.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the performance of the new algorithm in detecting stage I CRCs. Today’s update shows yet again that Shield delivers best-in-class performance," said AmirAli Talasaz, Guardant Health co-CEO. "We will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time."

The clinical validation of the algorithm was conducted on an expanded cohort of subjects enrolled in the landmark ECLIPSE study. ECLIPSE is a 20,000+ person registrational study evaluating the performance of Shield for detecting CRC in average-risk adults that was published in The New England Journal of Medicine. Sensitivity for early-stage CRC was 62% for stage I and 100% for stage II. Sensitivity was 96% for stage III and 100% for stage IV. Sensitivity in detecting advanced adenomas was 13%.

The National Comprehensive Cancer Network (NCCN) recently updated its CRC Screening Guidelines to add Shield as the first blood test that is FDA approved for primary screening of CRC. Shield has also received numerous awards recognizing its innovation and power to change lives, including Fast Company’s World Changing Ideas, TIME’s list of the Best Inventions of 2024 and was selected as a Grand Award Winner in Popular Science’s Best of What’s New 2024.

Beyond CRC screening, Guardant Health has a pipeline of activities around the Shield platform, including the Shield multi-cancer detection (MCD) test which was recently granted Breakthrough Device Designation by the FDA and included in the National Cancer Institute’s Vanguard study.

Shield is the first and only blood test that has received full FDA approval as a primary screening option for CRC in average-risk adults aged 45 and older and can be ordered by any prescribing healthcare provider. For more information, visit www.ShieldCancerScreen.com.