DiaSorin announced that it has completed at the Spallanzani Hospital in Rome and at the Policlinico San Matteo in Pavia, the studies necessary to support the CE marking and FDA EUA submission of an innovative molecular test for the rapid identification of the novel coronavirus COVID-19.
The test is designed for the LIAISON® MDX instrument using its Direct Amplification Disc technology (DAD), enabling sample-to-answer results within 60 minutes compared to the 5-7 hours currently necessary to report patient results.
This product is expected to be launched in Europe CE marked and submitted to the FDA under the Emergency Use Authorization process by the end of March 2020.
This technology, thanks to the fast time to result and ease of use, is ideal to triage patients for hospital admission and DiaSorin believes it could greatly help the hospital systems to decentralize Coronavirus testing and provide a meaningful improvement to the current admission process of potentially contagious patients.
DiaSorin’s test will follow the WHO recommended protocol targeting several regions of the viral genome to minimize the impact of possible future mutations. “As soon as the sequence information was made available we immediately began working to this project in conjunction with the Reference Centers in Italy and the US to develop fast and accurate molecular assays to provide a response to this outbreak. We have analyzed over 150 viral sequences published today in the world genebank database and designed a diagnostic test intended to detect all the currently known variants of the Coronavirus COVID-19”, said Giulia Minnucci, R&D Director Europe at DiaSorin.
For more info: https://diasoringroup.com/sites/diasorincorp/files/allegati_pressrel/diasorin_avvia_sviluppo_test_per_coronavirus.pdf