Bringing Clarity to Clinical Decisions
Early detection remains essential to improving outcomes for bladder cancer patients.
IRVINE, Calif. - October 1, 2025 - 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.
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.
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
This company announcement contains forward-looking statements and estimates with respect to the anticipated future performance of Vesica Health and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Vesica Health expressly disclaims any obligation to update any such forward-looking statements in this announcement to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This company announcement does not constitute an offer or invitation for the sale or purchase of securities or assets of Vesica Health in any jurisdiction. No securities of Vesica Health may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
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.