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
LGC Clinical Diagnostics

Download Mobile App




First-of-Its-Kind Multiplex Protein-Based Urine Test Detects Bladder Cancer

By LabMedica International staff writers
Posted on 13 May 2022
Print article
Image: Nonagen’s Oncuria bladder cancer diagnostic panel uses xMAP Luminex technology (Photo courtesy of Pexels)
Image: Nonagen’s Oncuria bladder cancer diagnostic panel uses xMAP Luminex technology (Photo courtesy of Pexels)

As a highly recurrent disease, bladder cancer is a major health concern that places an immense burden on healthcare systems. Up to 77% of early-stage bladder tumors that are treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) will recur. More than half of patients who receive Bacillus Calmette-Guérin (BCG) therapy as the first-line treatment for bladder cancer will fail to respond. In addition, in 20% of patients, the disease grows and extends during or after BCG therapy. Now, a first-of-its-kind multiplex protein-based urine test that provides early and accurate detection, therapy choice, and disease monitoring of bladder cancer can help improve patient outcomes.

Nonagen Bioscience Corporation (Los Angeles, CA, USA) has entered into an agreement with Bio-Techne Corporation (Minneapolis, MN, USA) to exclusively manufacture its Oncuria bladder cancer diagnostic panel using xMAP Luminex technology. The Luminex-based multiplex assay panel combines Bio-Techne's high-quality reagents with Nonagen's diagnostic expertise to create a powerful solution to advance bladder cancer treatment strategies. Nonagen’s lead diagnostic, Oncuria, is a breakthrough multiplex immunoassay for the quantitative detection of biomarkers in urine that are associated with the presence of bladder cancer.

Oncuria is designed to detect 10 proteins in a multiplex immunoassay in urine specimens from persons with hematuria suspected of having bladder cancer or urine specimens from persons with a history of bladder cancer on tumor surveillance. Unlike current urine-based technologies, such as cytology, fluorescent probes, and mRNA, bladder cancer tumor proteins are well understood in the scientific literature and readily identified in the urine, offering a more effective approach to cancer detection. In clinical studies, Oncuria was shown to have 93% sensitivity and 93% specificity for detecting bladder cancer. Additionally, Oncuria has demonstrated consistent sensitivity and specificity across bladder cancer tumor grades and stages. Oncuria’s high level of accuracy is especially meaningful for detecting low-grade tumors, which is an area of high unmet need in bladder cancer management.

Results from Oncuria are intended for use, in conjunction with, not in lieu of, current standard diagnostic procedures as an aid for initial diagnosis of bladder cancer in patients with hematuria, and for subsequent monitoring of tumor recurrence in patients previously diagnosed with bladder cancer. In September 2021, the US FDA had granted Oncuria a Breakthrough Device Designation for predicting response to BCG therapy, a first-line treatment for bladder cancer. Nonagen and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT.

"We're excited to partner with Bio-Techne to make Oncuria available as a laboratory developed test (LDT), given their extensive biomarker discovery expertise," said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "Bio-Techne also shares our passion for translating research discoveries into innovative diagnostics, to improve the detection and management of cancer."

"We look forward to working with Nonagen to develop this game-changing immunoassay in the fight against bladder cancer," said Will Geist, President of Bio-Techne's Protein Sciences division. "Nonagen's deep experience in diagnostic and testing research is complementary to Bio-Techne's extensive immunoassay expertise and world-class manufacturing capabilities, creating an ideal partnership for this important bladder cancer detection assay."

Related Links:
Nonagen Bioscience Corporation 
Bio-Techne Corporation

Platinum Supplier
ADAMTS-13 Protease Activity Test
ATS-13 Activity Assay
New
Gold Supplier
Turbidimetric Control
D-Dimer Turbidimetric Control
Complement 3 (C3) Test
GPP-100 C3 Kit
New
Gold Supplier
Spinal Fluid Cell Count Control
Spinalscopics

Print article

Channels

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

Hematology

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

Immunology

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

Microbiology

view channel
Image: Current testing methods for antibiotic susceptibility rely on growing bacterial colonies in the presence of antibiotics (Photo courtesy of 123RF)

Rapid Antimicrobial Susceptibility Test Returns Results within 30 Minutes

In 2019, antimicrobial resistance (AMR) was responsible for the deaths of approximately 1.3 million individuals. The conventional approach for testing antimicrobial susceptibility involves cultivating... Read more

Pathology

view channel
Image: AI methods used in satellite imaging can help researchers analyze tumor images (Photo courtesy of Karolinska Institutet)

AI Approach Combines Satellite Imaging and Ecology Techniques for Analysis of Tumor Tissue

Advancements in tumor imaging technology have significantly enhanced our ability to observe the minute details of tumors, but this also brings the challenge of interpreting vast amounts of data generated... Read more

Technology

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

Industry

view channel
Image: The acquisition significantly expands Medix Biochemica’s portfolio of IVD raw materials (Photo courtesy of ViroStat)

Medix Biochemica Acquires US-Based ViroStat to Expand Infectious Diseases Antibody Offering

Medix Biochemica (Espoo, Finland), a supplier of critical raw materials to the in vitro diagnostics (IVD) industry, has acquired ViroStat LLC (Portland, ME, USA), a provider of infectious disease antibodies... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.