PanGIA Biotech, a leader in non-invasive cancer diagnostics, presented findings at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) from a prospective, multi-center validation study evaluating its AI-powered, urine-based platform for early-stage prostate cancer detection.

The study, Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), is the first to clinically validate PanGIA®’s novel approach—pairing proprietary chemistry with machine learning to detect cancer-specific biosignatures from a single, non-invasive urine sample.

“This study confirms what we’ve believed from the start: there’s power in non-invasive, data-driven diagnostics,” said Holly Magliochetti, CEO of PanGIA Biotech. “Our platform helps clinicians detect prostate cancer when intervention is most effective—without costly or invasive procedures.”

Key findings presented included:

• Study Cohort: 197 biopsy-confirmed prostate cancer patients and 84 healthy controls.
  
  
• Classifier Performance: Achieved an F1 score of 0.843 with a recall of 0.967 in distinguishing cancer from non-cancer subjects.
  
  
• Gleason Score Cohorts: Maintained high recall (>0.89) across Gleason scores 6 through 10, with F1 scores ranging from 0.799 to 0.838.
  
  
• Non-Invasive Advantage: Demonstrated strong performance in detecting intermediate- and low-grade cancers, offering a less invasive alternative to traditional diagnostics.

Unlike invasive biopsies or blood-based tests that often miss early-stage cases, PanGIA’s approach analyzes urinary biosignatures using proprietary AI models—eliminating the need for sequencing and enabling cost-effective, globally scalable testing.

Previously published in The Analyst, a journal of the Royal Society of Chemistry¹, the PanGIA platform is designed for diverse healthcare environments and holds promise for broad global adoption.