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

Urine-Based, Non-Invasive Molecular Test Accurately Detects Bladder Cancer

By LabMedica International staff writers
Posted on 25 Nov 2022
Print article
Image: UriFind is a urine-based, non-invasive molecular test for detection of bladder cancer (Photo courtesy of Pexels)
Image: UriFind is a urine-based, non-invasive molecular test for detection of bladder cancer (Photo courtesy of Pexels)

Bladder cancer is a common type of cancer with a high recurrence rate. It has an estimated 84,000 new cases, and 17,300 deaths in the U.S. in 2021. The majority (>90%) of bladder cancer cases are urothelial carcinomas. Cystoscopy, followed by biopsy of suspicious lesions, remains the gold standard for diagnosis of both new and recurrent bladder cancer. However, the approach is highly invasive and costly, due to which bladder cancer is being called the most expensive single cancer. In addition, urine cytology and other methods have poor performance as compared with cystoscopy. Now, a new study aims to evaluate the performance of a non-invasive, quantitative real-time PCR (qPCR) assay designed to detect two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer.

AnchorDx (Guangzhou, China)'s UriFind is a urine-based, non-invasive molecular test for accurate detection of bladder cancer. The performance of the UriFind test has shown to provide improved sensitivity and specificity over cytology and other assays. It offers advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer.

AnchorDx has now achieved the first patient enrollment for the UriFind bladder cancer assay clinical trial in the U.S., an over 1,000-patient multi-center, prospective testing of the assay in the targeted patients. In July 2021, the assay was granted a Breakthrough Device Designation (BTD) by the U.S. Food and Drug Administration (FDA). Results of this clinical trial are aimed towards meeting the requirements for an application for a Premarketing Approval (PMA) to the FDA in the U.S. The trial is expected to include about 10 sites of urology clinics and three CAP/CLIA laboratories.

"The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the U.S. Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high performing test for detection of bladder cancer. We are excited to evaluate its ability to inform patient care," said Marina Bibikova, Chief Scientific Officer of AnchorDx.

"AnchorDx is committed to transform early detection and diagnosis of cancer as we continuously bring our tests into clinical practice through clinical validation," added Jian-Bing Fan, Founder and Chief Executive Officer. "We are collaborating with leading urologists world-wide to gain important clinical evidence on the use of our UriFind test. This clinical trial represents an important step towards commercialization of the test in the U.S."

Related Links:

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
POCT Fluorescent Immunoassay Analyzer
Gold Member
Real-time PCR System
GentierX3 Series

Print article


Clinical Chemistry

view channel
Image: The 3D printed miniature ionizer is a key component of a mass spectrometer (Photo courtesy of MIT)

3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more


view channel
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more


view channel
Image: A false color scanning election micrograph of lung cancer cells grown in culture (Photo courtesy of Anne Weston)

AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell

Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample.... Read more


view channel
Image: Microscope image showing human colorectal cancer tumor with Fusobacterium nucleatum stained in a red-purple color (Photo courtesy of Fred Hutch Cancer Center)

Mouth Bacteria Test Could Predict Colon Cancer Progression

Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger... Read more


view channel
Image: Fingertip blood sample collection on the Babson Handwarmer (Photo courtesy of Babson Diagnostics)

Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection

Warming the hand is an effective way to facilitate blood collection from a fingertip, yet off-the-shelf solutions often do not fulfill laboratory requirements. Now, a unique hand-warming technology has... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.