Vesica Health Receives AUA Guideline Inclusion

IRVINE, Calif. - EntSun -- VESICA HEALTH^®, INC., a precision diagnostics company improving the early detection and management of bladder cancer, today announced that its flagship test, AssureMDx, has been formally recognized in the newly updated American Urological Association (AUA) Guidelines for the evaluation of patients with microscopic hematuria. Hematuria—blood in the urine—is the most common presenting symptom of bladder cancer.

The 2025 AUA guideline update recommends that validated urine-based genomic tests—such as AssureMDx—may be used to assess bladder cancer risk in patients with low- to intermediate-risk microscopic hematuria. This guidance supports the integration of AssureMDx into clinical practice to inform decisions about urologic referral and cystoscopy.

"Hematuria remains one of the most frequently encountered and clinically complex presentations in urology," commented Sam S. Chang, MD, MBA, Professor of Urology, Patricia and Rodes Hart Chair of Urologic Surgery and Chief Surgical Officer, Vanderbilt-Ingram Cancer Center at Vanderbilt University. "AssureMDx offers a practical, evidence-based tool that helps clinicians more confidently determine which patients need more intensive evaluation—while reducing unnecessary invasive procedures. Its inclusion in the AUA guidelines reflects the meaningful utility it provides to both patients and providers."

"Inclusion of AssureMDx in the AUA guidelines represents a pivotal milestone for both patients and providers," stated Laura Caba, MPH, President of Vesica Health. "This recognition highlights the strength of our clinical evidence and the important role AssureMDx plays in improving early detection and risk stratification. It marks a defining moment for clinical adoption and continued momentum toward precision care in urology."

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This achievement affirms the clinical utility of AssureMDx and validates Vesica Health's long-standing commitment to advancing evidence-based diagnostics for urologic oncology. With guideline inclusion, AssureMDx is now positioned within the standard of care—supporting broader adoption by clinicians, health systems, and payers, and supporting broad reimbursement.

"This milestone is the result of a focused effort to generate rigorous evidence through well-designed, prospective studies that demonstrate the value of AssureMDx for patients with hematuria," added Caba. "It reflects our mission to improve early detection and survival by delivering precision diagnostics that are both clinically actionable and accessible."

About AssureMDx^™

AssureMDx is a proprietary, noninvasive urine-based DNA test clinically validated to improve the early detection of bladder cancer. The assay integrates six genomic and epigenetic biomarkers—DNA methylation of TWIST1, OTX1, and ONECUT2, and somatic mutations in FGFR3, HRAS, and TERT—to stratify hematuria patients for expedited urologic evaluation while safely ruling out those at very low risk.

Vesica Health's genes and technology have been reported in more than 26 peer-reviewed publications involving over 8,500 patients across detection, prognostic, and predictive applications. This body of evidence includes three prospective clinical validation studies evaluating the final six-gene configuration of the AssureMDx assay for early detection. In the largest multicenter study (n=838; van Kessel et al., Journal of Urology, 2020), AssureMDx demonstrated an overall sensitivity of 96%, a negative predictive value greater than 99%, and an AUC of 0.96 for bladder cancer detection. Answering the clinical community's call for earlier, more accurate detection, AssureMDx achieved a combined sensitivity of 95.9% for Stage 0 (Ta and Tis/CIS) and Stage I disease—underpinning its unique ability to identify patients at increased risk for bladder cancer at its earliest and most treatable stages.

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AssureMDx has been recognized in the AUA Clinical Guidelines as a validated urine-based genomic test for the evaluation of patients with low- to intermediate-risk microscopic hematuria, further reinforcing its clinical utility within the standard of care.

About Vesica Health^®, Inc.

Vesica Health is a privately held precision diagnostics company pioneering noninvasive solutions for the early detection and management of bladder cancer. Hematuria—blood in the urine—affects more than 17 million U.S. adults annually, yet only 12% are referred for urologic evaluation, resulting in an estimated 20,000 missed bladder cancer diagnoses each year.

Headquartered in Irvine, California, Vesica operates a CAP-accredited, CLIA-certified laboratory and holds worldwide commercialization rights for AssureMDx. The company is led by an experienced team with a proven track record in diagnostic development, clinical evidence generation, and commercial execution. In addition to its flagship assay, Vesica is advancing a pipeline that includes recurrence monitoring, prognostic, and predictive companion diagnostics.

Vesica Health is positioned to lead in the $6 billion bladder cancer diagnostics market, with a mission to improve survival and patient care through earlier detection, precision diagnostics, and expanded access to noninvasive solutions. Learn more at: www.vesicahealth.com.

For investment and partnership inquiries, or to learn more about AssureMDx, please contact Vesica Health Corporate Communications at: public.relations@vesicahealth.com