We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App

Non-Invasive Urine Test for Bladder Cancer Could Eliminate Need for Painful Cystoscopy

By LabMedica International staff writers
Posted on 09 Oct 2023
Print article
Image: Current data suggests URO17 is the most sensitive/specific for bladder cancer test (Photo courtesy of KDx Diagnostics)
Image: Current data suggests URO17 is the most sensitive/specific for bladder cancer test (Photo courtesy of KDx Diagnostics)

Blood in the urine, or hematuria, is the most common symptom of bladder cancer. However, many patients with microscopic amounts of blood in their urine don't actually have bladder cancer, yet they must undergo invasive tests like cystoscopy to rule it out. Other confirmatory methods like CT scans, intravenous pyelograms, X-rays, MRIs, ultrasounds, and urine cytology also have their limitations. Now, a non-invasive urine test with high sensitivity and negative predicted value (NPV) can help exclude these patients from undergoing unnecessary invasive cystoscopy procedures, thereby streamlining the diagnostic process.

KDx Diagnostics (Los Gatos, CA, USA) has developed the URO17 test, a non-invasive urine test with remarkable sensitivity and NPV for determining active bladder cancer and enhancing patient diagnosis. This test is based on a unique biomarker, Keratin 17 (K17), and is among the most accurate urine tests for bladder cancer. The test uses immunocytochemistry and is compatible with the majority of autostainer platforms commonly found in reference labs. Preliminary research indicates that the URO17 test has a 100% sensitivity and 96% specificity rate for identifying recurring bladder cancers and a 100% sensitivity and 92.6% specificity rate for identifying new cases of bladder cancer in patients with hematuria.

Currently, the URO17 test is available in the United States as a Laboratory Developed Test (LDT) through select reference laboratories and is sold as a CE-IVD kit outside the U.S. The test has received the Breakthrough Device Designation from the FDA and is currently in clinical trials for FDA approval. KDx Diagnostics aims to create additional tests based on the K17 biomarker for various platforms and sample types and plans to expand its range of cancer diagnostic tests. The company has obtained important patents in the U.S., the European Union, and South Korea for technologies that analyze K17 in urine to detect or rule out bladder cancer.

"These new patents complement our ongoing commercial efforts to provide non-invasive technologies for bladder cancer detection and demonstrate we've made groundbreaking advances," said Nam W. Kim, PhD, CEO and CTO at KDx, and coinventor of the patents. "We are focused on delivering cutting-edge solutions that address the needs of our customers and drive industry growth."

Related Links:
KDx Diagnostics 

Platinum Supplier
ADAMTS-13 Protease Activity Test
ATS-13 Activity Assay
Gold Supplier
Melanoma Panel
UltraSEEK Melanoma Panel
Complement 3 (C3) Test
GPP-100 C3 Kit
Chikungunya & Dengue Virus Test

Print article


Clinical Chemistry

view channel
Image: A module with eight micro-devices, complete with microfluidic channels and drive motors (Photo courtesy of U.S Department of Energy)

Highly Sensitive pH Sensor to Aid Detection of Cancers and Vector-Borne Viruses

Understanding the acidity or alkalinity of substances through pH measurement is crucial in many fields, from environmental monitoring to healthcare product safety. In many cases, these measurements must... Read more

Molecular Diagnostics

view channel
Image: Scientists have discovered a new amyloid-forming protein in neurodegenerative disease (Photo courtesy of 123RF)

Discovery of Rogue Protein Paves Way for Diagnostic Test to Detect Early-Onset Dementia

Neurodegenerative disorders are often marked by the buildup of amyloid filament inclusions of specific proteins in the brain. These proteins are critical in diagnosing and treating the associated diseases.... Read more


view channel
Image: The QScout hematology analyzer has received US FDA 510(k) clearance (Photo courtesy of Ad Astra Diagnostics)

First Rapid-Result Hematology Analyzer Reports Measures of Infection and Severity at POC

Sepsis, a critical medical condition that arises as an extreme response to infection, poses a significant health threat. It occurs when an infection triggers a widespread inflammatory response in the body.... Read more


view channel
Image: PointCheck is the world’s first device for non-invasive white cell monitoring (Photo courtesy of Leuko Labs)

World’s First Portable, Non-Invasive WBC Monitoring Device to Eliminate Need for Blood Draw

One of the toughest challenges for cancer patients undergoing chemotherapy is experiencing a low count of white blood cells, also known as neutropenia. These cells play a crucial role in warding off infections.... Read more


view channel
Image: Three examples of Anthrobots with hair-like cilia in yellow (Photo courtesy of Gizem Gumuskaya)

Tiny Biological Robot Healers Built From Human Cells Could Recognize Bacteria

In a pioneering study, researchers have developed microscopic biological robots, termed Anthrobots, from human tracheal cells. These tiny robots, varying in size from the width of a human hair to the tip... Read more


view channel
Image: Made-to-order diagnostic tests may soon be on the horizon (Photo courtesy of McGill University)

Breakthrough in Diagnostic Technology Could Make On-The-Spot Testing Widely Accessible

Home testing gained significant importance during the COVID-19 pandemic, yet the availability of rapid tests is limited, and most of them can only drive one liquid across the strip, leading to continued... Read more


view channel
Image: Covaris offers instruments, consumables, and reagents for high-throughput genomic and proteomic analysis (Photo courtesy of Covaris)

PerkinElmer Acquires Covaris to Create Global Life-Sciences and Diagnostics Platform

PerkinElmer, Inc. (Waltham, MA, USA), a global analytical services and solutions provider has acquired Covaris (Woburn, MA, USA), a developer of solutions to empower life science innovations.... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.