AssureMDx
Molecular Diagnostic Assay
AssureMDx is a multi-omics, liquid biopsy urine test designed to triage patients with hematuria who are at risk for bladder cancer and to monitor for recurrence in post-treatment patients. It is offered as a laboratory-developed test (LDT) performed in the company's CLIA-certified, CAP-accredited laboratory.
- Integrates DNA methylation and somatic mutation biomarkers for a comprehensive analysis
- Achieves 96% overall sensitivity and a 99% Negative Predictive Value (NPV)
- Demonstrates 95.9% sensitivity for detecting early Stage 0/I bladder cancer
- Recognized in AUA guidelines for evaluating intermediate-risk microscopic hematuria
- Received FDA Breakthrough Device Designation to expedite the path to full marketing authorization
Built for
The primary customers are physicians, particularly urologists, who manage patients with hematuria or a history of bladder cancer. The end-users are the patients themselves who require evaluation or surveillance.
