Vesica Health Announces Launch of AssureMDx Test to Improve Bladder Cancer Detection

IRVINE, Calif., May 3, 2024 /PRNewswire/ -- VESICA HEALTH, INC., a leading multi-omics liquid biopsy company dedicated to improving the management of hematuria patients and the early detection of bladder cancer, today announced the launch of its laboratory-developed AssureMDx^™ test.

Christopher Thibodeau, Chief Executive Officer of Vesica Health, expressed his enthusiasm, stating, “We are delighted to officially introduce AssureMDx for patient testing. With an extensive evidence dossier of over 22 peer-reviewed publications, including three clinical validation studies, coupled with the recent successful completion of our analytical validation, we stand prepared to empower hematuria patients and their physicians with this vital tool for enhancing patient care.”

Laura Caba, MPH, President of Vesica Health, underscored the significance of this innovation, declaring, “We are reshaping the landscape of early bladder cancer detection and fulfilling our commitment to elevating patient care and clinical outcomes.”

AssureMDx represents a significant leap forward in bladder cancer diagnostics, offering unparalleled accuracy and reliability backed by rigorous scientific validation. This transformative test embodies Vesica Health’s unwavering dedication to advancing the standard of care for hematuria patients worldwide.

About AssureMDx^™
AssureMDx is a multi-omic noninvasive urine-based DNA test designed to transform the triage of hematuria patients. By providing physicians with a precise method for identifying patients at increased risk for bladder cancer, AssureMDx facilitates immediate urological referral and clinical evaluation when needed. Importantly, the test also helps physicians effectively distinguish patients at very low risk, who may bypass invasive procedures and avoid unnecessary CT scans, thereby reducing potential radiation exposure risks. Backed by extensive research, the AssureMDx epigenetic and somatic biomarkers have been reported in 22 peer-reviewed studies involving over 6,000 patients, including multiple prospective clinical validation studies. These studies consistently demonstrate the test’s robust clinical performance, notably 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), and 96% Sensitivity for the detection of bladder cancer in hematuria patients. Moreover, AssureMDx will provide urologists a noninvasive means to monitor bladder cancer patients at heightened risk of recurrence following treatment, thereby enhancing patient management and improving outcomes.

About Vesica Health, Inc.
At Vesica Health, our mission is clear: to revolutionize the management of hematuria patients, enhance the early detection of bladder cancer, and improve patient survival. Hematuria, characterized by blood in the urine, affects an estimated 17 million (1-in-5) adult Americans annually, serving as the most common symptom of bladder cancer. Despite guideline recommendations, only 12% of patients are referred to urology for clinical evaluation, resulting in approximately 20,000 diagnoses missed each year. Delayed detection leads to later-stage disease and increased mortality rates. Conventional diagnostic methods like cytology and cystoscopy, while widely used, suffer from lower sensitivity and often fail to detect bladder cancer. Moreover, the fear of undetected cancer prompts a high rate of CT scans, exposing patients to unnecessary radiation and an increased risk of secondary cancer later in life. Drawing from 20 years of advanced multi-omics research in bladder cancer detection, AssureMDx is a clinically validated, noninvasive test that helps improve the evaluation of hematuria, enhance early disease detection, and enable effective recurrence monitoring. For more information on our groundbreaking initiatives, visit www.vesicahealth.com.

For more information:
Vesica Health Corporate Communications
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.

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SOURCE Vesica Health