Vesica Health Announces Publication of Study Demonstrating AssureDx Meaningfully Improves Identification of Hematuria Patients at High Risk for Bladder Cancer

IRVINE, Calif., Oct. 9, 2023 /PRNewswire/ -- VESICA HEALTH, INC., a multi-omics, liquid biopsy company transforming the management of hematuria patients and improving the early detection of bladder cancer, today announced the peer-reviewed publication of a study demonstrating that its noninvasive, urine-based AssureDx^™ genomic test delivers a statistically significant improvement in the identification of patients at increased risk for bladder cancer. Notably, in patients with microhematuria AssureDx delivers an impressive 0.97 AUC with a positive test result resulting in a 5-fold increase in the risk of harboring bladder cancer, compared to the current risk assessment metrics alone.

The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology. The study analyzed a prospectively collected cohort of 838 hematuria subjects previously tested by AssureDx. Subjects were classified into the AUA risk categories for bladder cancer based on their sex, age, and type of hematuria, also known as urothelial carcinoma (UC). The AssureDx multi-omics biomarker analysis included DNA mutation status for the FGFR3, TERT, and HRAS genes and DNA methylation status for the OTX1, ONECUT2, and TWIST1 genes. Application of AssureDx testing revealed robust performance among all risk groups with a 0.96 AUC (area under the receiver operating characteristic curve) for the full cohort. The study demonstrated AssureDx's efficacy in enhancing the American Urological Association's (AUA) hematuria guidelines.

"AssureDx promises to deliver a paradigm shift in patient care, providing primary care physicians a highly sensitive yet noninvasive method to accurately identify patients at increased risk for urothelial carcinoma," reported Dr. Gerald L. Andriole, M.D., formerly Professor in the Department of Urology and Director of the Brady Urological Institute in the National Capital Region of Johns Hopkins University. Previously, he was the Chief of Urologic Surgery at Barnes-Jewish Hospital and the Robert K. Royce Distinguished Professor at the Siteman Cancer Center and Washington University School of Medicine in St. Louis, Missouri. Dr. Andriole continued: "It is noteworthy that the authors recommend expedited urological evaluation of AUA intermediate and high-risk hematuria patients with a positive AssureDx test result, concluding that these patients have a very high probability of harboring cancer. Primary care physicians are often uncertain how to manage patients with hematuria and as a consequence, too frequently disease has progressed to later stages by the time the patient is referred to the urology clinic for evaluation."

"Publication of this pivotal study in a leading international urology journal, demonstrating AssureDx enhances the AUA Guidelines, underscores the importance of the test for risk stratification of hematuria patients and identification of those at increased risk for bladder cancer," statedChristopher Thibodeau, Chief Executive Officer of Vesica Health. "Results from this study provide further clinical evidence that the AssureDx test delivers actionable information to improve the early detection of bladder cancer when there is the greatest opportunity for cure."

About AssureDx^™
Vesica Health's patented, noninvasive, urine-based AssureDx test helps physicians accurately triage hematuria (blood in urine) patients, distinguishing those at high risk for bladder cancer, who may benefit from immediate referral to urology and clinical evaluation, from those at very low risk for bladder cancer, who may safely avoid invasive procedures and secondary cancer risk from harmful CT scans. AssureDx biomarkers and technology have been extensively reported in 20 peer-reviewed and published studies on over 5,878 patients, including three sequential, prospective clinical validation studies, delivering robust clinical performance with a 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), 96% Sensitivity and 83% Specificity for the detection of bladder cancer in hematuria patients. AssureDx also provides urologists with a noninvasive method to monitor bladder cancer patients at increased risk of recurrence after initial treatment, thereby improving patient management and outcomes.

About Vesica Health, Inc.
Vesica Health's mission is to transform the management of hematuria patients and improve the early detection of bladder cancer. Each year it is estimated that 17 million (1-in-5) adult Americans will be diagnosed with hematuria, the presence of blood in the urine, which is the most common symptom of bladder cancer. Yet despite guideline recommendations, only ~12% of patients are referred to urology for clinical evaluation. The traditional diagnostic procedures, cytology and cystoscopy, employed for the detection of bladder cancer suffer from lower sensitivity and are prone to miss cancer. As a consequence, ~20% of bladder cancers are missed each year, leading to later-stage disease at diagnosis and higher mortality. Fear of undetected cancer leads to a high rate of CT scans on patients to exclude upper tract disease, exposing patients to radiation and potential iatrogenic cancer later in life. Vesica has translated 20 years of advanced multi-omics research in bladder cancer into a well-validated, commercial-ready noninvasive test to improve the evaluation of hematuria, early detection of disease, and recurrence monitoring. For more information, please visit www.vesicahealth.com.

For more information:
Vesica Health Corporate Communications
publicrelations@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 AssureDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners.

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