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U.S. Department of Health and Human Services

DiaSorin Molecular LLC Simplexa COVID-19 Direct Assay

ASPR’s Portfolio of COVID-19 Medical Countermeasures under EUA

BARDA is supporting the development of DiaSorin Molecular LLC’s Simplexa COVID-19 Direct Assay, which was developed to run on the LIAISON® MDX real time PCR platform. This  platform is a fully automated sample to answer system that can be used for random access testing, with a throughput capacity of up to 96 samples per hour. The platforms have been placed in the US and globally, including multiple placements in hospitals and large reference laboratories. To learn more, see the award announcement.

Emergency Use Authorization

On March 19, 2020, FDA issued an Emergency Use Authorization (EUA) to allow DiaSorin Molecular LLC’s Simplexa COVID-19 Direct Assay to be used to diagnose COVID-19.

  • This page last reviewed: May 21, 2020