Research & Development
FDA Approves EUA Amendment Increasing Applied DNA's COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms
31 July 2020 - - The US Food and Drug Administration has granted an Emergency Use Authorization amendment that both expands the installed base of PCR equipment platforms that can process US-based DNA manufacturing specialist Applied DNA Sciences Inc's (NASDAQ: APDN) Linea COVID-19 Assay Kit and introduces automation to significantly increase the throughput of the assay by use of robotic RNA extraction, the company said

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.

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 country 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.

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.
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