KDx Diagnostics Inc. (KDx) is a developer of novel diagnostic tests that improve early detection and management of cancer. KDx is the developer of the URO17® bladder cancer diagnostic test, which is one of the most sensitive and specific urine tests for bladder cancer. The URO17® test is available in the US as a Laboratory Developed Test (LDT) through selected reference laboratories, and available as a CE-IVD kit outside the US. URO17® was awarded the Breakthrough Device Designation from FDA , and is currently undergoing clinical trial for FDA approval.
The URO17® test is a non-invasive urine test for bladder cancer based on a novel biomarker Keratin 17 (K17) co-invented by KDx and the Stony Brook Medical center. The URO17® test is an immunocytochemical test using an antibody developed by KDx which is compatible with most autostainer platforms that are available in most reference laboratories. Initial studies on the URO17® test showed that the test has 100% sensitivity and 96% specificity in detecting recurrent bladder cancers in the monitoring population (Babu et al., 2019), and 100% sensitivity and 92.6% specificity in detecting new bladder cancers from patients with hematuria (Vasdev et al., 2020).