Applied DNA Receives FDA Emergency Use Authorization for COVID-19 Diagnostic Assay Kit

By LabMedica International staff writers
Posted on 15 May 2020

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Applied DNA Sciences Inc. (Stony Brook, NY, USA) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the clinical use of the company’s patent-pending Linea COVID-19 RT-PCR test.

The Linea COVID-19 assay kit is an rRT-PCR (reverse transcription, Real Time Polymerase Chain Reaction)-based assay designed to detect specific highly conserved target sequences of the SARS-CoV-2 Spike (S) gene. The advanced single-well multiplex test allows for simple set up and higher-throughput as compared to tests that require multiple wells per test. The Linea COVID-19 assay is approved to run on the FDA-approved Applied Biosystems QuantStudio Dx real-time PCR instrument, which allows for testing results for up to 94 samples within one hour, or more than 2,000 tests in 24 hours per device. Clinical laboratories in the US certified under Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests can immediately begin ordering and using the Linea COVID-19 assay kit to detect SARS-CoV-2.

“I am very proud of our development team, who, despite the challenges presented by the current global pandemic, developed our Linea COVID-19 assay kit, filed patent applications, established supply chain relationships, developed our initial customer prospects and secured FDA EUA approval all within record time,” said Dr. James A. Hayward, president and CEO of Applied DNA.

“We believe we have developed an assay with numerous commercial advantages over other EUA approved COVID-19 detections assays. We developed the Linea COVID-19 assay kit for high-throughput operations where rapid high-volume testing is requisite. In addition, we have worked closely with our supply chain partners to evolve safeguards to ensure a steady supply of inputs necessary for the construction of our kit,” said Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA.

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