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

Download Mobile App




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

By LabMedica International staff writers
Posted on 25 Nov 2022

Bladder cancer is a common type of cancer with a high recurrence rate. More...

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:
AnchorDx


New
Gold Member
Hematology Analyzer
Medonic M32B
Collection and Transport System
PurSafe Plus®
New
Anterior Nasal Specimen Collection Swabs
53-1195-TFS, 53-0100-TFS, 53-0101-TFS, 53-4582-TFS
New
Gold Member
Immunochromatographic Assay
CRYPTO Cassette
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The VENTANA HER2 (4B5) test is now CE-IVDR approved (Photo courtesy of Roche)

Companion Diagnostic Test Identifies HER2-Ultralow Breast Cancer and Biliary Tract Cancer Patients

Breast cancer is the most common cancer in Europe, with more than 564,000 new cases and 145,000 deaths annually. Metastatic breast cancer is rising in younger populations and remains the leading cause... Read more

Pathology

view channel
Image: An adult fibrosarcoma case report has shown the importance of early diagnosis and targeted therapy (Photo courtesy of Sultana and Sailaja/Oncoscience)

Accurate Pathological Analysis Improves Treatment Outcomes for Adult Fibrosarcoma

Adult fibrosarcoma is a rare and highly aggressive malignancy that develops in connective tissue and often affects the limbs, trunk, or head and neck region. Diagnosis is complex because tumors can mimic... Read more

Technology

view channel
Image: Conceptual design of the CORAL capsule for microbial sampling in the small intestine (H. Mohammed et al., Device (2025). DOI: 10.1016/j.device.2025.100904)

Coral-Inspired Capsule Samples Hidden Bacteria from Small Intestine

The gut microbiome has been linked to conditions ranging from immune disorders to mental health, yet conventional stool tests often fail to capture bacterial populations in the small intestine.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.