Vesica Health has introduced AssureMDx test, a non-invasive urine-based DNA test for improving bladder cancer detection in hematuria patients.
The test is set to offer a significant advancement in the diagnostics of bladder cancer, providing a high level of accuracy and reliability.
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AssureMDx is a multi-omic test that aids physicians in identifying patients at an increased risk for bladder cancer, allowing for timely urological referrals.
It also helps in identifying patients with a very low risk, potentially sparing them from invasive procedures and unnecessary CT scans, thus reducing exposure to radiation.
The test’s epigenetic and somatic biomarkers have undergone extensive research, with findings from 22 peer-reviewed studies involving more than 6,000 patients.
These studies have shown AssureMDx’s strong clinical performance, with a 0.96 area under the receiver operating characteristic curve (AUC), 99% Negative Predictive Value (NPV), and 96% sensitivity for detecting bladder cancer in hematuria patients.
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By GlobalDataVesica Health CEO Christopher Thibodeau said: “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.”
Using a simple urine sample, the AssureMDx test evaluates the presence of specific DNA biomarkers which are related to bladder cancer.
The test will also serve as a noninvasive method for monitoring bladder cancer patients at a higher risk of recurrence post-treatment. This will enhance patient management and potentially improve long-term outcomes.
