Pharma News

FDA grants amendment in Emergency Use Authorization of COVID-19 Assay Kit

  • Posted on: 27 November 2020
  • By: PharmaTutor News

Applied DNA Sciences, Inc a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that expands the installed base of RT-PCR platforms that can process the Company’s Linea™ COVID-19 Assay Kit. The EUA amendment extends the RT-PCR platform authorization from Applied Biosystems’ (ThermoFisher Scientific) QuantStudio™ Dx and QuantStudio™ 5 Real-Time PCR systems to include Applied Biosystems™ 7500 Fast Dx Real-Time PCR System (ABI 7500). The ABI 7500 has the capacity to perform 400 – 800 tests in 24 hours and is found in the majority of clinical laboratories nationally.