Vesica Health Granted PLA Billing Code for AssureMDx
illi News/10314906

IRVINE, Calif. - illiNews -- VESICA HEALTH^®, INC., a precision diagnostics company improving the early detection and management of bladder cancer, today announced that the American Medical Association (AMA) has granted a Proprietary Laboratory Analysis (PLA) billing code for its AssureMDx™ test. The new code, effective January 2026, represents a critical de-risking milestone in Vesica Health's path to commercialization, establishing a recognized billing pathway that will enable reimbursement and support adoption of AssureMDx across the U.S. healthcare system. This achievement positions Vesica Health to accelerate revenue generation and deliver meaningful near-term value creation for our shareholders, while at the same time expanding access for patients.

"Securing a PLA code from the American Medical Association is a foundational milestone," said Christopher Thibodeau, Chief Executive Officer, Vesica Health. "It underscores the continued execution of our commercial strategy to expand access to AssureMDx, drive adoption across the healthcare system, and advance our mission to improve early detection and outcomes for patients, providers, and payers."

The AssureMDx PLA code (0613U) has been published in the AMA's Directory: https://www.ama-assn.org/practice-management/cpt/cpt-pla-codes

By establishing a clear reimbursement pathway, this milestone validates Vesica Health's position with payers, enables provider adoption, expands patient access, and demonstrates the company's ongoing commitment to all stakeholders.

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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.

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

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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

NOTE: The Vesica Health wordmarks and logos, including Vesica Health, and AssureMDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners.