Multiplex and multi-omic diagnostic test for bladder cancer recurrence

Following initial diagnosis and treatment, bladder cancer has a high recurrence rate, making it one of the most expensive cancers to treat over a patient’s lifetime. The current standard of care testing for bladder cancer recurrence is an invasive medical procedure, cystoscopy. Urine contains a wealth of biomarkers that can potentially be used to monitor for signs of recurrence and early initiation of treatment. However, commercially available biomarker-based bladder cancer tests rely on a single type of biomarker, are insufficiently sensitive, often yield false negative and false positive results, and are time and resource intensive. Therefore, the development of new approaches that afford high accuracy results are the key to improving patient care and treatment. To meet this need, Early Is Good developed a bladder cancer diagnostic assay, called BCDx. BCDx uses advanced nanotechnology to detect twelve different biomarkers directly from a urine sample. The comprehensive approach is multi-omic multiplex because it measures the concentration of proteins, miRNAs, mRNAs, and lncRNAs. Feasibility studies demonstrated attomolar sensitivity for each biomarker, with high positive predictive and negative predictive values for biomarkers that are present in picomolar concentrations in urine samples derived from healthy volunteers and bladder cancer patients. Moreover, BCDx can distinguish healthy versus oncogenic samples and can discriminate between low grade and high-grade tumors. In a pilot clinical study, BCDx demonstrated diagnostic feasibility, reliability, and validity. The goal of this proposal is to execute a clinical validation study that is designed to complete the acquisition of data required by the FDA for regulatory clearance through the 510(k) pathway. Beyond setting the state for regulatory clearance, Phase II completion is expected to help promote the adoption of BCDx by clinicians and healthcare professionals and to secure reimbursement from payers.