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
Technopath Clinical Diagnostics - An LGC Company

Download Mobile App




Events

ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.

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

New
Gold Supplier
Benchtop Real-Time PCR Analyzer
Savanna
New
Automatic Hematology Analyzer
BF-7200Plus
New
3-Part Diff Hematology Analyzer
DLB3
New
Auto Clinical Chemistry Analyzer
Mispa Clinia Plus

Print article

Channels

Clinical Chem.

view channel
Image: The analysis pipeline used to investigate associations between blood metabolites, later life brain imaging measures, and genetic risk for Alzheimer’s disease (Photo courtesy of University College London)

Lipid Measurements Show Potential as Alzheimer’s Disease Biomarkers

Brain changes accompanying ageing are varied and can include pathologies that lead to cognitive impairment, the commonest of which is Alzheimer’s disease (AD). Identifying blood-based signatures of brain... Read more

Hematology

view channel
Image: The CS-2500 analyzer features pre-analytic sample checks and four detection methods simultaneously on a single platform – coagulation end-point, chromogenic kinetic analysis, turbidimetric immunoassay and automated platelet aggregation (Photo courtesy of Sysmex)

Microvascular/Endothelial Dysfunction Contributes to Post-COVID Syndrome Pathogenesis

Post-COVID syndrome (PCS) or Long-COVID is an increasingly recognized complication of acute SARS-CoV-2 infection, characterized by persistent fatigue, reduced exercise tolerance chest pain, shortness of... Read more

Industry

view channel
Image: Sales of lateral flow assays in clinical testing are expected to register a CAGR of 5% through 2032 (Photo courtesy of Pexels)

Global Lateral Flow Assays Market to Surpass USD 11.5 Billion by 2032 Due to Evolving Applications

The global lateral flow assays market was valued at USD 7.2 billion in 2021 and is projected to register a CAGR of 4.7% during 2022-2032 to surpass USD 11.7 billion by the end of 2032, driven by the growing... Read more
Copyright © 2000-2022 Globetech Media. All rights reserved.