A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

AnchorDx’s Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns “Breakthrough Device Designation” from FDA

What To Know

  • As an innovative biotechnology enterprise in China with a global perspective, AnchorDx constantly promotes the registration and certification of advanced cancer early detection technology around the world and is making every effort to accelerate the global market authorization of UriFind, with a view to enabling it to serve more population in need as soon as possible.
  • AnchorDx, a world-leading developer of cancer screening and early detection solutions, on July 13, 2021, was awarded a Breakthrough Device Designation (“BTD”)[1] by the US Food and Drug Administration (FDA) for UriFind (or “the Test”), an early detection test for bladder cancer based on urine DNA methylation detection.

AnchorDx, a world-leading developer of cancer screening and early detection solutions, on July 13, 2021, was awarded a Breakthrough Device Designation (“BTD”)[1] by the US Food and Drug Administration (FDA) for UriFind (or “the Test”), an early detection test for bladder cancer based on urine DNA methylation detection. This is the first BTD granted to liquid biopsy test for bladder cancer detection in China.

Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless, and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine. The performance of the Test has shown to be as strong as that of cystoscopy, and significantly better than exfoliative cytology and Fluorescence in situ hybridization (FISH) in the detection of early and non-muscle invasive bladder cancer (NMIBC). The Test demonstrates increased advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer.

The Test’s research achievements have been published in The Journal of Clinical Investigation[2] and Clinical Epigenetics. Following years’ of real-world sample accumulation and verification by AnchorDx, the accuracy, sensitivity and specificity of UriFind have now reached 89.3%, 87.4% and 91.5% respectively. During the FDA-BTD approval process, AnchorDx provided head-to-head experiment results with another internationally approved product, proving the Test’s superior performance in detection sensitivity and ease-of-use.

UriFind’s detection method has been included in the newly released 2021 Guidelines for Diagnosis and Treatment of Bladder Cancer in China and has also gained EU CE marking. In addition, AnchorDx has also passed the medical device quality management system certification – TUV ISO 13485 Certification.

At present, AnchorDx’s UriFind has entered the registered clinical trials stage in China, and clinical trials in the United States will be launched soon. Once the Test obtains the US market authorization from FDA, a four-year national medicare coverage[3] will be provided. As an innovative biotechnology enterprise in China with a global perspective, AnchorDx constantly promotes the registration and certification of advanced cancer early detection technology around the world and is making every effort to accelerate the global market authorization of UriFind, with a view to enabling it to serve more population in need as soon as possible.


[1] Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program
[2] Chen X, Zhang J, Ruan W, et al. Urine DNA methylation assay enables early detection and recurrence monitoring for bladder cancer[J]. The Journal of clinical investigation, 2020 https://doi.org/10.1172/JCI139597
[3] Medicare Coverage of Innovative Technology (CMS-3372-F) https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f

SourceAnchorDx
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The study is designed to assess the clinical utility and workflow benefits of Swoop® system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions).
“Tom and I have more than 50 years of experience,” Harp adds. “The decision to found Polymer Medical was done after careful consideration of the landscape and market opportunity; we will raise the level of competition and quality for customers.” Polymer Medical is located in a newly refurbished plant is at 168 Thorn Ave., Orchard Park, N.Y.
The RWE Program will expand Summus Laser's Class IV Laser Therapy research to generate validated and statistically significant datasets that will be used to enhance patient care, outcomes, and to further product innovations.
Details of the session: Polaroid Therapeutics & Avery Dennison Medical: How the power of partnership brings a novel approach to antimicrobial wound dressings.
SABIC advises the project was initiated together with the dialysis department at Jessa Hospital, one of the largest non-university medical cluster in the Limburg region of Flanders, Belgium.

By using this website you agree to accept Medical Device News Magazine Privacy Policy