“We appreciate the continued collaboration of FDA in assisting us to improve the availability and throughput of our COVID-19 diagnostic kit.”

By HospiMedica International staff writers
Posted on 03 Aug 2020

Applied DNA Sciences Inc. (Stony Brook, NY, USA) has been granted Emergency Use Authorization (EUA) amendment by the US Food and Drug Administration (FDA) that expands the installed base of PCR equipment platforms which can process the company’s Linea COVID-19 Assay Kit and introduces automation to significantly increase the throughput of the assay by use of robotic RNA extraction.

The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio Dx to include Applied Biosystems’ QuantStudio 5 Real-Time PCR system (QS5). The amendment also authorizes the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-tek Mag-Bind viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput. The company believes the amendment can greatly enhance the efficiency of laboratories across the US who adopt the diagnostic kit while expanding by more than tenfold the target installed base of authorized RT-PCR equipment. To match the potential for higher demand, the company is increasing production of its diagnostic kit.