Finnish biotech company Mobidiag announces CE-marked herpesvirus microarray for rapid In Vitro Diagnostics (IVD) of life-threatening central nervous system infections.
The achieved certificate ensures the safety of the product in clinical use and opens European markets for the company. Prove-it™ Herpes identifies seven herpesviruses in a single assay, whereas most current methods search for only one virus at a time, or are unable to identify all viruses covered by Mobidiag’s assay.
Human herpesviruses cause life-threatening infections in the central nervous system such as encephalitis, the inflammation of the brain. The European estimated prevalence of central nervous system infections caused by herpesviruses is close to a million a year. Thus, the annual market size for herpesviral diagnostics is 100 million euros in Europe alone.
"Due to the diverse symptoms of herpesviral infections, the clinician faces a great challenge in either confirming or ruling out the infection based on clinical examination alone", said Jaakko Pellosniemi, CEO of Mobidiag. "Rapid diagnostics is vital. Left untreated, the mortality in encephalitis can be as high as 50%. Prove-it™ Herpes provides rapid and reliable results enabling correct targeting of antiviral treatment", Pellosniemi continued.
The clinical performance and safety of Prove-it™ Herpes was evaluated at six University, hospital or private laboratories around Europe. The results of analyzing 525 cerebrospinal fluid samples in parallel with the current DNA-based methods were excellent: sensitivity 90% and specificity 98%. Prove-it™ Herpes demonstrated additional value by identifying 14 multi-infections and 17 Human Herpesvirus 7 infections missed or not covered by the current diagnostics. Furthermore, Mobidiag’s test found twenty infections not suspected by the clinician at all.
"No longer the clinician needs to know which virus test to choose – Prove-it™ Herpes answers all questions at once. Furthermore, the coverage of the assay eliminates the need for multiple tests and thereby saves time and can halve the diagnostics costs in hospitals", Pellosniemi said.
Source: Mobidiag Ltd
