Multi-Omic Noninvasive Urine-Based DNA Test to Improve Bladder Cancer Detection

Hematuria, the presence of blood in urine, is commonly associated with bladder cancer and is its most frequent symptom. Current guidelines recommend referring patients with hematuria to urology for clinical evaluation; however, only 12% receive such referrals, leading to an estimated 20,000 missed diagnoses annually. This lack of timely detection results in more advanced disease stages and higher mortality rates. Traditional diagnostic approaches like cytology and cystoscopy are commonly employed but are hampered by low sensitivity, often failing to detect bladder cancer effectively. Additionally, the concern for missed cancer diagnoses has led to an increased use of CT scans, which expose patients to unnecessary radiation and elevate the risk of developing secondary cancers later. Now, a novel noninvasive urine-based test that assesses genomic alterations linked to bladder cancer promises to more accurately identify patients who are at high risk and would benefit from a urological evaluation, while also distinguishing those at low risk who could safely forego invasive and potentially harmful diagnostic procedures.

Vesica Health (Irvine, CA, USA) has launched AssureMDx, a noninvasive, multi-omic urine-based DNA test designed to transform the triage of patients with hematuria. This test provides clinicians with a precise tool for identifying patients at increased risk of bladder cancer, thus facilitating timely referrals for urological evaluation and clinical intervention. Importantly, the test also aids in identifying patients at very low risk, who might avoid unnecessary invasive procedures and CT scans, thereby minimizing exposure to potentially harmful radiation. AssureMDx marks a significant advancement in the field of bladder cancer diagnostics, combining exceptional accuracy and reliability supported by strong scientific validation.

Supported by extensive research, the epigenetic and somatic biomarkers of AssureMDx have been documented in 22 peer-reviewed studies involving more than 6,000 patients, including multiple prospective clinical validation studies. These studies have consistently shown the test's robust clinical performance, with notable metrics such as a 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), and 96% Sensitivity in detecting bladder cancer among patients presenting with hematuria. Additionally, AssureMDx offers urologists a noninvasive way to monitor patients with bladder cancer who are at increased risk of recurrence after treatment, thereby enhancing patient care and improving long-term outcomes.

"We are delighted to officially introduce AssureMDx for patient testing,” said Christopher Thibodeau, Chief Executive Officer of Vesica Health. “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."