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 hp
Sign In
Advertise with Us
RANDOX LABORATORIES

Download Mobile App




New Urine Test Improves Accuracy for Early Detection of Bladder Cancer in Patients with Hematuria

By LabMedica International staff writers
Posted on 26 Jun 2024
Print article
Image: An illustrated outline of the EarlyTect Bladder Cancer Detection and its clinical applications (Photo courtesy of Promis Diagnostics)
Image: An illustrated outline of the EarlyTect Bladder Cancer Detection and its clinical applications (Photo courtesy of Promis Diagnostics)

Blood in the urine, known as hematuria, is often one of the earliest signs of bladder cancer. Although cystoscopy is recommended for patients presenting with both microscopic and gross hematuria, the detection rate for bladder cancer in these patients varies widely from 2% to 20%, leading to many unnecessary procedures. Additionally, due to the invasive nature of cystoscopy and low patient compliance, many cases of hematuria, especially microhematuria, are not promptly examined, missing early detection opportunities. This often results in diagnoses at more advanced stages, increasing both physical and economic burdens. To address these challenges, researchers have developed a simplified DNA-based urine test to enhance the early detection accuracy of bladder cancer in patients with hematuria and reduce reliance on more invasive cystoscopies.

The potential of aberrant DNA methylation as a diagnostic biomarker for various cancers, including bladder cancer, has been recognized for some time. Researchers from Genomictree, Inc. (Daejeon, South Korea) and Promis Diagnostics, Inc. (Irvine, CA, USA) had previously developed a diagnostic tool that measures methylation levels of proenkephalin (PENK) in urine DNA using a two-step real-time PCR process for detecting primary bladder cancer in hematuria patients. They have now streamlined this into a single-step procedure, EarlyTect Bladder Cancer Detection (BCD), which integrates linear target enrichment (LTE) and quantitative methylation-specific PCR (qMSP) in a closed-single tube system using real-time PCR.

The performance of EarlyTect BCD was assessed for its sensitivity and specificity and compared favorably with other multi-biomarker tests. In a retrospective training set of 105 patients, an optimal cutoff value was identified that distinguished bladder cancer from non-cancer cases, achieving a sensitivity of 87.3% and a specificity of 95.2%. In a prospective validation set involving 210 patients (122 Korean and 88 American), the test showed an overall sensitivity of 81.0% for detecting all stages of bladder cancer, with a high negative predictive value of 97.7% for ruling out bladder cancer in patients with hematuria.

Remarkably, EarlyTect BCD demonstrated 100% sensitivity in identifying high-grade noninvasive papillary carcinoma and more advanced stages of bladder cancer. These results indicate that the test could transform clinical practice by enhancing the initial diagnosis of hematuria patients, significantly reducing the number of unnecessary cystoscopies. Patients with a positive urine test could then be more confidently referred for cystoscopy by an urologist, increasing the likelihood of detecting early-stage bladder cancer.

“With the urgent requirement for early bladder cancer detection during initial diagnosis, EarlyTect BCD emerges as a promising solution with minimal complexity, heightened robustness, and, most importantly, user-friendliness, making it easy to implement in clinical laboratory practice,” said lead investigator Sungwhan An, PhD, Genomictree, Inc. “These novel diagnostic approaches may revolutionize the field of bladder cancer diagnosis, reducing bladder cancer mortality rates and treatment-associated healthcare expenses.”

Related Links:
Genomictree, Inc.
Promis Diagnostics, Inc.

New
Platinum Member
Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test
Magnetic Bead Separation Modules
MAG and HEATMAG
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Dengue Virus Test
LINEAR Dengue-CHIK

Print article
77 ELEKTRONIKA

Channels

Clinical Chemistry

view channel
Image: The new DxC 500i Clinical Analyzer is an integrated clinical chemistry and immunoassay analyzer (Photo courtesy of Beckman Coulter Diagnostics)

Integrated Chemistry and Immunoassay Analyzer with Extensive Assay Menu Offers Flexibility, Scalability and Data Commutability

As global healthcare systems increasingly shift towards networked laboratory operational models to enhance efficiency and patient access, there is a greater need for innovative solutions tailored to the... Read more

Hematology

view channel
Image: The Truvian diagnostic platform combines clinical chemistry, immunoassay and hematology testing in a single run (Photo courtesy of Truvian Health)

Automated Benchtop System to Bring Blood Testing To Anyone, Anywhere

Almost all medical decisions are dependent upon laboratory test results, which are essential for disease prevention and the management of chronic illnesses. However, routine blood testing remains limited worldwide.... Read more

Microbiology

view channel
Image: The Simplexa C. auris direct kit is a real-time polymerase chain reaction assay run on the LIAISON MDX instrument (Photo courtesy of Diasorin)

Novel Molecular Test to Help Prevent and Control Multi Drug-Resistant Fungal Pathogen in Healthcare Settings

Candida auris (C. auris) is a rapidly emerging multi drug-resistant fungal pathogen that is commonly found in healthcare environments, where it presents a challenge due to its ability to asymptomatically... Read more

Pathology

view channel
Image: Color-enhanced scanning electron micrograph showing Salmonella Typhimurium (red) invading cultured human cells (Photo courtesy of Rocky Mountain Laboratories, NIAID, NIH)

AI Identifies Drug-Resistant Typhoid-Like Infection from Microscopy Images within Hours

Antimicrobial resistance is becoming a serious global health concern, making many infections increasingly difficult to treat and limiting available treatment options. This escalation in resistance raises... Read more

Industry

view channel
Image: Beckman Coulter will utilize the ALZpath pTau217 antibody to detect key biomarker for Alzheimer\'s disease on its DxI 9000 immunoassay analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter Licenses Alzpath's Proprietary P-tau 217 Antibody to Develop Alzheimer's Blood Test

Cognitive assessments have traditionally been the primary method for diagnosing Alzheimer’s disease, but this approach has its limitations as symptoms become apparent only after significant brain changes... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.