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Mobidiag Gains CE-IVD Mark for Sepsis Test

NEW YORK (GenomeWeb News) - Mobidiag, a Helsinki, Finland-based biotechnology firm, this week said that its Prove-it array-based in vitro diagnostic for sepsis has met the requirements for CE-IVD marking and can now be marketed to clinicians in Europe.
Prove-it Sepsis enables the simultaneous identification of 50 bacterial species in less than three hours on the firm’s TubeArray platform. The seven-year-old company met the requirements of European directives governing CE-IVD marking after completing a 3,300-patient study in the University College London Hospitals and the Hospital Districts of Helsinki and Uusimaa, or HUS, in Finland.
Jukka Anttila, a doctor at HUS, in a statement called Prove-it Sepsis an “important step towards quicker and more precise sepsis diagnostics helping in treatment decisions and improving hospital hygiene, especially in preventing the spreading of multiresistant bacteria” such as methicillin-resistant Staphylococcus aureus.
CEO Jaakko Pellosniemi told GenomeWeb Daily News sister publication BioArray News this week that Mobidiag, which has several tests in development, decided to develop a test for sepsis because it is the “most difficult infection to diagnose, and it so happens that our technology suits the identification of multiple pathogens that [are] causing sepsis.”
Pellosniemi said that the CE-IVD marking is significant for his company because, to date, it has only sold products for research use. “Hospitals can’t base their treatment decisions on RUO products,” Pellosniemi said. CE-IVD marking “allows us to get into routine diagnostics in hospitals. This is not testing or research; it’s the real thing,” he added.
Mobidiag’s initial target customers will be larger clinical hospitals in Europe. Pellosniemi said that there are approximately 400 such hospitals in Europe. He also said that Mobidiag ultimately wants to pursue US Food and Drug Administration clearance for Prove-it Sepsis but did not provide a timeframe.
According to Pellosniemi, Mobidiag plans to expand both its technical support and sales and marketing personnel to support the launch of the test. The results of the 3,300-patient sample study will also be published in the future, he said.