Irvine, California, March 6, 2026

Promis Diagnostics, a molecular diagnostics company based in Irvine, California, today announced that clinical results for its enhanced urine-based bladder cancer test, EarlyTect Bladder Cancer Detection (BCD) Plus, have been published in the peer-reviewed journal BJUI Compass. The study has also been selected for a late-breaking oral presentation at the 2026 European Association of Urology (EAU) Annual Congress in London, one of the world’s leading scientific meetings in urology.

The multicenter study included 892 patients presenting with hematuria and 144 patients undergoing bladder cancer recurrence monitoring across clinical sites in the United States and South Korea. Diagnostic performance was evaluated using prospectively collected, retrospectively analyzed urine samples, with results compared to cystoscopy and histopathological confirmation.

In patients presenting with hematuria, EarlyTect BCD Plus demonstrated 96.6% sensitivity (95% CI: 91.5–99.1%) for detecting high-grade bladder cancer, the most clinically significant form of the disease with the greatest risk of progression. Across all bladder cancer stages, the test achieved 87.7% sensitivity and 82.5% specificity, with a negative predictive value of 99.1% in intermediate-risk patients defined by American Urological Association (AUA) guidelines, supporting its potential as a non-invasive rule-out tool in hematuria evaluation. The study also demonstrated a high negative predictive value of 98.4% in patients with high-risk microhematuria, indicating reliable exclusion of bladder cancer across risk groups.

Positive predictive value increased with clinical risk, reaching 42.3% in patients with high-risk microhematuria and 62.8% in patients with visible hematuria, suggesting potential utility for identifying individuals who may benefit from prioritized cystoscopic evaluation. Given that many patients with hematuria do not undergo timely cystoscopic evaluation in real-world practice, a reliable rule-in signal may help prioritize referral for cystoscopy and support earlier diagnosis of bladder cancer.

EarlyTect BCD Plus builds on the validated PENK DNA methylation biomarker platform, incorporating a dual-site CpG island design that expands methylation analysis within the same biomarker region to improve sensitivity, analytical stability, and result consistency, supporting repeated testing and longitudinal disease monitoring. The test is designed for non-invasive monitoring of treatment response and minimal residual disease (MRD) in patients with established bladder cancer. The EarlyTect technology platform, originally developed by Genomictree, Inc. (KOSDAQ: 228760), was further evaluated in this study through collaboration between Promis Diagnostics and Genomictree.

Together, EarlyTect BCD and EarlyTect BCD Plus are intended to support bladder cancer management across the care pathway—from initial evaluation and diagnosis to long-term monitoring and follow-up. EarlyTect BCD Plus further expands the platform with a non-invasive approach for monitoring treatment response and disease recurrence.