“By providing rapid and accurate results, we are redefining infectious disease diagnostics. The evaluation results demonstrate the high performance of our Prove-it technology, and with today’s Bone and Joint announcement, our product portfolio now covers a diagnostics market of over 2 million clinical samples per year in Europe,” said Mobidiag’s CEO Jaakko Pellosniemi.
Mobidiag’s Prove-it Herpes microarray assay achieved excellent results in an international multicenter evaluation where the product was compared with current PCR-based methods. Prove-it Herpes can identify eight different human herpesviruses simultaneously whereas current tests commonly search for only one type of virus at a time. In the evaluation study, Prove-it Herpes showed clinical sensitivity of 92 % and specificity of 98 %. In 20 of the 460 examined cerebrospinal fluid (CSF) samples, the test uncovered pathogens that were not found with the reference methods. Additionally, the test demonstrated 12 multi-infections which were missed by current diagnostics. Prove-it Herpes also identified 15 patients with an HHV7 infection not found by the reference methods.
“Due to the wide variety of symptoms, it is difficult to confirm herpesviral infection based only on clinical examination. Rapid diagnostics is vitally important as mortality from untreated encephalitis caused by human herpesviruses can be as high as 50 %. Prove-it Herpes enables rapid diagnostics of the infection and helps doctors choose the correct antiviral treatment,” Pellosniemi continued.
Mobidiag also launched the Prove-it Bone and Joint product for quickly identifying bacteria responsible for bone and joint infections (BJIs), such as osteomyelitis and septic arthritis. Every year, more than 150,000 people within the EU are infected with BJIs. Currently, the diagnosis of BJI’s relies on cultures, which are time consuming and subject to false negative results. Mobidiag’s Prove-it Bone and Joint identifies bacteria directly from a clinical sample in only three hours, and enables targeted antimicrobial treatment to be started quickly.