Bringing Clarity to Clinical Decisions
Early detection remains essential to improving outcomes for bladder cancer patients.
IRVINE, CA – OCTOBER 9, 2023 – 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 AssureMDx™ genomic test delivers a statistically significant improvement in the identification of patients at increased risk for bladder cancer. Notably, in patients with microhematuria AssureMDx 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 AssureMDx. 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 AssureMDx multi-omics biomarker analysis included DNA mutation status for the FGFR3, TERT, and HRAS genes and DNA methylation status for the OTX1, ONECUT2, and TWIST1genes. Application of AssureMDx 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 AssureMDx's efficacy in enhancing the American Urological Association's (AUA) hematuria guidelines.
“AssureMDx 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 AssureMDx 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 AssureMDx 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,” stated Christopher Thibodeau, Chief Executive Officer of Vesica Health. “Results from this study provide further clinical evidence that the AssureMDx test delivers actionable information to improve the early detection of bladder cancer when there is the greatest opportunity for cure.”
Vesica Health’s patented, noninvasive, urine-based AssureMDx 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. AssureMDx 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), 96% Sensitivity, and 99% Negative Predictive Value (NPV) for the detection of bladder cancer in hematuria patients. AssureMDx 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.
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
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