DELRAY BEACH, Fla., April 2, 2026 /PRNewswire/ -- PanGIA Biotech, Inc. ("PanGIA") announced a peer-reviewed clinical study published in Diagnostics, "Urine-Based Machine Learning Assay Detects Prostate Cancer," ¹ demonstrating clinical validation of its PanGIA Analysis System ("PAS") platform, a urine-based liquid biopsy platform powered by machine learning.

The study, based on PanGIA's GH-215 clinical program, evaluated 283 participants across 26 U.S. urology practices. Results showed 97.8% sensitivity across all Gleason grades and 97.3% specificity for high-grade cancers, with an AUC of 0.91 and consistent performance observed through cross-validation. The study was published open access in Diagnostics.

The study also highlights the potential for a urine-based liquid biopsy to reduce unnecessary surgical biopsies while supporting earlier and more informed clinical decision-making.

These findings demonstrate that prostate cancer can be detected through a urine-based liquid biopsy, with machine learning interpreting biomolecular signature patterns derived from metabolites and other biochemical signals in urine across the disease spectrum.

The results build on PanGIA's prior peer-reviewed work and further position PAS as a platform capable of detecting disease through pattern-based analysis rather than reliance on single biomarkers.

"This marks an important external validation of our platform and reinforces the clinical and scientific foundation underlying our diagnostic pipeline," said Holly Magliochetti, PanGIA Biotech CEO and Co-Founder. "It reflects both the rigor of the work and the potential for broader application across multiple cancer types."

PanGIA integrates non-invasive urine sample collection, biomolecular-signature profiling, and machine-learning-driven analysis to enable a scalable liquid biopsy approach to early cancer detection and monitoring.

"This study reflects a different way of approaching cancer detection," said Obdulio Piloto, PhD, Chief Scientific Officer and Co-Founder of PanGIA Biotech. "Rather than targeting a single biomarker, this urine-based liquid biopsy uses machine learning to interpret complex biochemical patterns. That allows us to capture signals that may be missed by more reductionist approaches and supports detection across the full spectrum of disease."

The full study is available at:
https://www.mdpi.com/2075-4418/16/7/993

About PanGIA Biotech, Inc.
PanGIA Biotech develops AI-integrated, urine- and CSF-based liquid biopsy solutions designed for global scalability. The PanGIA® Analysis System combines non-invasive sample collection, biomolecular-signature profiling, and machine-learning-driven pattern recognition that supports early detection, monitoring, and disease management—including cancer as early as Stage 1. Backed by patents and peer-reviewed research, PanGIA is committed to advancing innovation that supports earlier detection and better health outcomes.

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¹Hausman MS, Ambert K, Nagesetti A, Lim FBH, Swaminathan M, Cardwell RF, Piloto O. Urine-Based Machine Learning Assay Detects Prostate Cancer. Diagnostics. 2026;16(7):993.

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SOURCE PanGIA Biotech