NEW YORK ─ Berlin-based Scienion on Wednesday announced a partnership with the Institute for Prevention and Occupational Medicine of the German Social Accident Insurance, also known as IPA, to develop a multiplexed, lateral-flow diagnostic platform for bladder cancer.
The platform would detect 10 biomarkers from a urine sample in less than 20 minutes at the point of care or in a laboratory, said Scienion, part of Gothenburg, Sweden-based Bico. The bladder cancer test, called Urofast, will "enable rapid, scalable, and affordable testing for this aggressive form of cancer," said Wilfried Weigel, VP of research and development at Scienion.
IPA, a German academic research institute of the Ruhr University Bochum, is leveraging its knowledge of biomarkers and more than 500 urine samples from its biobank as part of the diagnostic test's development while Scienion is using its automated precision dispensing technology to print biomarkers on the lateral flow immunoassay.
The test's manufacturing process will adhere to the European Union’s In Vitro Medical Devices Regulation, Scienion said, adding that along with IPA, it intends to seek worldwide regulatory approvals when the current project is completed in 2024.
The project is partly funded by a central innovation program for small- and medium-size enterprises at Germany's Federal Ministry of Economics and Technology.