Vesica Health's AssureMDx: Revolutionizing Surveillance for Bladder Cancer Patients

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Mar 26, 2024, 15:33 ET

IRVINE, Calif., March 26, 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 had their urine-based biomarker featured in a recent peer-reviewed publication. The study showcases the efficacy of its noninvasive AssureMDx^™ test in detecting urinary tract recurrence after bladder-sparing treatment among patients with muscle-invasive bladder cancer (MIBC).

Scheduled for publication in the April 2024 issue of European Urology Open Science, the study, "A Genomic Urine Assay for Surveillance of Patients with Bladder Cancer Treated with Radiotherapy," represents the first prospective evaluation of a urine-based molecular assay for monitoring MIBC outcomes post-radiation therapy (RT). Conducted from years 2016 to 2020 and involving 143 patients, the results of AssureMDx were compelling; it accurately detected urinary tract cancer recurrences and predicted future ones. Notably, the test exhibited a high negative predictive value (NPV) of 99%, offering reassurance by ruling out cancer recurrence in the urinary tract.

These findings underscore AssureMDx's effectiveness post-RT, presenting a promising alternative to conventional methods like cystoscopy and cytology, which are often hindered by the inflammatory effects of radiation on bladder tissue. AssureMDx holds immense potential to optimize patient care by streamlining surveillance, potentially reducing the need for invasive procedures such as cystoscopies and transurethral resection of bladder tumors (TURBTs), all while upholding diagnostic accuracy.

"There is a pressing need for less invasive methods to monitor MIBC patients after bladder-sparing radiation treatment, accommodating patients' heightened sensitivity while ensuring accurate surveillance for disease recurrence," commented Will Lowrance, M.D., Chief Medical Officer for Vesica Health. "Our aim is to bridge this gap by providing a noninvasive urine-based solution with AssureMDx, offering both clinical efficacy and comfort in post-treatment monitoring for bladder cancer patients."

"This study marks a pivotal advancement in bladder cancer surveillance, showcasing AssureMDx's transformative potential," emphasized Christopher Thibodeau, Chief Executive Officer of Vesica Health. "With its robust performance and easy implementation, AssureMDx is poised to revolutionize patient care, ushering in a new era of personalized surveillance."

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 high risk for bladder cancer, AssureMDx facilitates immediate urological referral and clinical evaluation when needed. Importantly, the test also effectively distinguishes those at very low risk, allowing patients to 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 21 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), 96% Sensitivity for the detection of bladder cancer in hematuria patients. Moreover, AssureMDx offers 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
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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.

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