Two-step screen + RT-qPCR validation yields AUC 0.94 (CRC) and 0.83 (advanced adenoma) in 114-sample pilot

PLEASANTON, Calif., Aug. 25, 2025 /PRNewswire/ -- A peer-reviewed study published in Scientific Reports, part of the Nature Portfolio, demonstrates a novel bioinformatic method for identifying messenger RNA (mRNA) biomarkers in stool that show high potential for the non-invasive detection of colorectal cancer (CRC) and advanced adenomas (AA), its most common precancerous lesion.

The research, which included scientists from El Capitan Biosciences (ECB) and his partner, utilized a two-step approach. First, a computational screen of public tissue databases ranked genes based on their differential expression in CRC versus normal colon tissue. The top candidate genes from this in silico analysis were then validated using RT-qPCR on 114 clinical stool samples (33 CRC, 28 AA, 53 controls).

The combined performance of the multi-gene mRNA panel was robust, achieving an Area Under the Curve (AUC) of 0.94 for discriminating CRC patients from controls, with 75.5% sensitivity and 95% specificity. For detecting advanced adenomas, which are frequently missed by current non-invasive tests, the panel achieved an AUC of 0.83 with 55.8% sensitivity and 92.6% specificity. This sensitivity for advanced adenomas compares favorably to the reported 10-40% sensitivity of fecal immunochemical tests (FIT).

The findings suggest that leveraging large public genomic datasets can effectively prioritize biomarker candidates for costly clinical validation, streamlining the development process for next-generation diagnostics.

"Improving the detection of precancerous lesions is a critical unmet need in colorectal cancer screening, as it allows for intervention before cancer develops," said Wenying Pan, PhD, Co-founder and CEO of El Capitan Biosciences. "Building on ECB's expertise in stool mRNA testing, we have established a proprietary platform for extracting human-host RNA from stool and a whole-transcriptome biomarker discovery platform. This platform effectively addresses a critical gap in the industry's understanding of the complete human stool transcriptome. It provides pharmaceutical companies researching intestinal diseases with a more comprehensive omics data perspective and, when combined with our unique bioinformatics algorithms, empowers the deep mining of novel targets and biomarkers. This advancement is poised to accelerate innovative drug target discovery and enhance the efficiency and success rates of clinical trials for our partners."

The study, Bioinformatic screen with clinical validation for the identification of novel stool based mRNA biomarkers for the detection of colorectal lesions including advanced adenoma, is available online with the DOI: 10.1038/s41598-025-13074-4.

Disclaimer: The investigational approach described is not cleared or approved by the U.S. FDA and is not available for clinical use.

About El Capitan Biosciences

El Capitan Biosciences (ECB) is a California-based company focused on the discovery of gut multi-omics biomarkers and the development of products for screening and diagnosing a range of gastrointestinal diseases. Its proprietary efficient method for extracting human-host RNA from stool, combined with a whole-transcriptome biomarker discovery platform, significantly enhances the development of clinical solutions for early disease detection, precision medication, and disease monitoring in intestinal disorders. For more information, visit www.elcapitanbio.com.

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SOURCE El Capitan Biosciences