Welcome to KDx Diagnostics
Building innovative diagnostics, filling unmet clinical needs
Building Innovative diagnostics, fulling unmet clinical needs.
About Us
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 available in the US as a Laboratory Developed Test (LDT) through selected reference laboratories, and available as a CE-IVD kit outside the US.
Product
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).
Recent News
EmeritusDX and KDx Diagnostics Inc. Announce a Partnership to Offer the URO17 NON-INVASIVE Urine Test for Bladder Cancer
IRVINE, CALIF., AND SAN JOSE, CALIF. (PRWEB) NOVEMBER 07, 2022 EmeritusDX and KDx Diagnostics announced today the partnership to provide the URO17 test for the detection of bladder cancer. URO17 is a non-invasive urine test with high sensitivity and negative predicted value (NPV) that can be used to determine the status of active bladder cancer...
KDx Diagnostics And Lister Hospital Announce The Launch Of A Non-Invasive URO17® Urine Test For Bladder Cancer In The United Kingdom
SAN JOSE, Calif. and STEVENAGE, England, Dec. 5, 2021 /PRNewswire/ — KDx Diagnostics, Inc. (KDx), and Lister Hospital (East and North Hertfordshire NHS Trust), Stevenage, UK, announced today the launch in the United Kingdom (UK) of KDx’s URO17® test for detection of bladder cancer. This non-invasive urine test for bladder cancer is highly sensitive for identifying...
SBU’s Ken Shroyer shows protein serves as marker of bladder, pancreatic cancers
By Daniel Dunaief Detectives often look for the smallest clue that links a culprit to a crime. A fingerprint on the frame of a stolen Picasso painting, a shoe print from a outside a window of a house that was robbed or a blood sample can provide the kind of forensic evidence that helps police...
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