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UgenTec Gets CE-IVD for PCR Interpretation Software

NEW YORK (GenomeWeb) – Belgian startup UgenTec announced today that it has received CE-IVD marking for its first product, software for the analysis and interpretation of real-time PCR data.

Called FastFinder, the software platform uses artificial intelligence to automate the interpretation of PCR results from different instruments and assays, translating raw PCR-data into a list of clearly defined true positives and true negatives. The software is now available to molecular labs as well as diagnostics manufacturers.

The firm has also received ISO 13485 certification.

"Obtaining ISO 13485 and the CE-IVD label is important to our company; not only does the certificate prove our expertise and advanced quality, but it also gives us a significant competitive edge in today's market," said UgenTec CEO Wouter Uten in a statement.

A spinoff of Leuven University, UgenTec raised $1.4 million in funding from venture capital firms and the Belgian government last year in order to further develop FastFinder's functionality. The software was then being used by several diagnostic laboratories in Belgium, the Netherlands, Luxembourg, Germany, and France. At the time, Uten also said that the company planned to expand its marketing of the product, including making plans to commercialize FastFinder in the US, pending approval from the US Food and Drug Administration.