FDA Grants An EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms

Saturday, November 28, 2020

Applied DNA Sciences Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that both expands the installed base of PCR equipment platforms that can process the Company’s LineaTM 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 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.

“Accessibility and turnaround times are two critical metrics for the successful commercial implementation of a diagnostic kit to serve communities affected by the COVID-19 crisis. With this EUA amendment we have accomplished both – a greatly increased installed base of RT-PCR devices upon which our assay can run, and also increased the speed and throughput of our assay through the use of a best-in-breed robotic platform. We appreciate the continued collaboration of FDA in assisting us to improve the availability and throughput of our diagnostic kit,” said Dr. James A. Hayward, president and CEO of Applied DNA. “As COVID-19 infection numbers spike in many parts of the country, we are also moving to increase kit production. We have been investing aggressively in our supply chains and established inventories to deliver greater patient accessibility to testing and for maximal market penetration.”

Michael Mouradian, vice president of Robotics at Hamilton Company, manufacturer of the Hamilton STARlet platform, said, “Our mission at Hamilton each day is to supply advanced liquid handling solutions that support the research and diagnostic testing communities confronting the COVID-19 pandemic.”

“We appreciate the opportunity to work with Applied DNA Sciences to help provide a reliable, reproducible RNA extraction solution,” said Travis Butts, vice president of Omega Bio-tek, manufacturer of the Omega Bio-tek Mag-Bind® viral RNA Express kit. “By partnering with Hamilton, we are able to implement an automated, high-throughput solution that can be deployed quickly and allow customers like Applied DNA Sciences to meet the demand for COVID-19 testing.”

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