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Coronavirus / Diagnostic Stock News Bites: Applied DNA (NASDAQ: $APDN) Receives FDA Emergency Use Authorization for COVID-19 Diagnostic Assay Kit

Kit offers same-day results to physician; Sensitivity to 1.25 copies of viral genome equates to less likely false negatives

Spike protein and the corresponding gene links the diagnostic assay to the Company’s LinearDNA™ Vaccine Strategy


May 14, 2020 ( Newswire) Applied DNA Sciences Inc. (NASDAQ: APDN) announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the clinical use of the Company's patent-pending Linea™ COVID-19 RT-PCR test for COVID-19. Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin ordering and using the Linea™ COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19.

The Linea™ COVID-19 assay kit is a high-sensitivity, high-fidelity 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 Linea™ COVID-19 assay is an advanced single-well multiplex test that 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.

"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. "This extraordinary achievement highlights the Company's commitment to combating the COVID-19 pandemic both locally and nationwide. We also thank our neighbor and collaborator Stony Brook University Hospital for its invaluable assistance."

Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA and a 30-year veteran of the RNA-based molecular diagnostics industry, stated, "We believe we have developed an assay with numerous commercial advantages over other EUA approved COVID-19 detections assays. We developed the LineaTM COVID-19 assay kit for high-throughput operations where accurate and 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."

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