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FDA Issues EUA to HymonSARS-CoV-2 Test Kit for Detection of COVID-19

SpectronRx and HymonBio expect to produce 10 million tests per month for labs around the world.

By: Contract Pharma

Contract Pharma Staff

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for SpectronRx’s HymonSARS-CoV-2 Test Kit.   According to SpectronRx, the kit offers the following benefits:   1.5-hour testing time, from prep to finish; 94 sample capacity (+ controls) per kit; LOD (Limit of Detection) of 1.2 copies of SARS-CoV-2 RNA/uL = 5 copies per reaction; Low laboratory footprint requirement.   The HymonSARS-CoV-2 Test Kit is a real-time RT-PCR test intended for the...

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