Point-of-Care Lateral Flow Test Detects Bladder Cancer Using Urine Sample within Minutes

SCIENION (Berlin, Germany) has entered into a partnership with the Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (IPA; North Rhine-Westphalia, Germany) to develop a novel bladder cancer diagnostic platform named UROfast. The diagnostic multiplexed lateral-flow technology aims to detect 10 different biomarkers from a simple urine sample in under 20 minutes. The technology can be deployed in a point-of-care or laboratory setting, providing a significantly less invasive process than the current standard.

Each year more than 275,000 people are diagnosed with bladder cancer worldwide, with an estimated 108,000 deaths. Early-stage bladder cancer can be successfully treated by surgery but has a very high recurrence rate, with up to 73% of patients being re-diagnosed within five years. This requires patients to participate in intensive follow ups and monitoring leading the disease to be one of the most expensive forms of cancer over time. The most common diagnostic tool used today is cystoscopy, an invasive and painful procedure in which physicians insert an imaging instrument via the urethra into the bladder to inspect for cancer occurrence.

The UROfast diagnostic platform will both significantly improve accessibility and convenience for patients and physicians through its non-invasive nature. As part of the development process, IPA will leverage their know-how on biomarkers and more than 500 urine samples of their biobank, while SCIENION will use its automated precision dispensing technology for printing multiple biomarkers on a lateral flow immunoassay. The entire manufacturing process follows the EU’s In-vitro Diagnostic Medical Devices Regulation (IVDR) and aims to be approved for use in laboratory and point-of-care settings. The collaboration kicked off in 2021 and will last through 2024 when the two organizations will seek regulatory approval across the world.

“The UROfast will be a gamechanger for both patients and physicians by enabling rapid, scalable, and affordable testing for this aggressive form of cancer,” said Wilfried Weigel, PhD, Vice President Research & Development, SCIENION. “We are thrilled to be working with IPA and will work tirelessly to bring this diagnostic to market to help save lives.”

“By simultaneously and quantitatively determining multiple biomarkers, we ultimately integrate the currently available knowledge on biomarker-based approaches for bladder cancer diagnostics into a single test procedure,” added Kerstin Lang, PhD, researcher at IPA and principal investigator in this project. “Our hope is to use invasive cystoscopy in a much more targeted manner to avoid associated side effects such as bleeding, burning and infection.”

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