Helsinki, Finland 16 May – the Finnish biotech company Mobidiag today announced that its Prove-it™ Herpes microarray assay has achieved excellent results in an international multicenter clinical evaluation study. The product showed sensitivity and specificity equaling or surpassing current methods and found several herpes infections missed by the reference test. The new Prove-it™ Herpes diagnostic assay simultaneously identifies eight clinically significant herpesviruses in only two hours, enabling quick choice of correct treatment.

The performance and safety of the PCR- and microarray-based Prove-it™ Herpes assay were validated with 460 cerebrospinal fluid (CSF) samples at six European clinical laboratories. In the evaluation study, Mobidiag’s Prove-it™ Herpes was compared to the current PCR-based methods. Prove-it™ Herpes showed clinical sensitivity of 92 % and specificity of 98 %. In 20 of the 460 examined samples, the test uncovered pathogens not found by the reference methods. Furthermore, the test demonstrated 12 multi-infections which were missed by current diagnostics and identified 15 patients with an HHV7 infection not found by the reference methods. In hospital use, Mobidiag’s test can reduce costs associated with herpesvirus diagnostics by almost 50 %.

Human herpesviruses cause life-threatening infections such as herpesviral encephalitis. It is often difficult to either confirm or rule out herpesviral infection based on clinical examination alone as symptoms in encephalitis range from mild fever and headache to altered consciousness and speech and hearing problems. Identifying which type of herpesvirus is causing the infection has so far been a time-consuming process because currently used methods typically search for only one type of virus at a time. Prove-it™ Herpes dramatically reduces the time it takes to find the reason for the infection as the product can identify eight different human herpesviruses simultaneously.

“Left untreated, the mortality in encephalitis caused by herpesviruses can be as high as 50 %. Rapid and reliable diagnostics are crucial in finding the correct antiviral treatment. With Prove-it Herpes, presence or absence of acute herpesviral infection can be confirmed in only two hours, helping the clinicians in choosing the correct treatment” said Mobidiag’s CEO Jaakko Pellosniemi.

The Prove-it™ Herpes test was originally developed in co-operation with Hospital Districts of Helsinki and Uusimaa and the University of Helsinki, Finland.

Contact:
CEO Jaakko Pellosniemi, Mobidiag Ltd, tel. 358 40 501 1004, jaakko.pellosniemi@mobidiag.com

Mobidiag Ltd is a Finnish biotechnology company developing, producing and marketing rapid diagnostic tests to hospital laboratories. The company focuses on diagnostics of serious infections with DNA-tests. More information at www.mobidiag.com.