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) to perform hi complexity tests. CLIA labs 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 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 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 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.”

For more information on the Linea™ COVID-19 assay kit, please visit www.adnas.com/dxcovid.

The Company notes that while the Linea™ COVID-19 assay kit has been approved by FDA under an EUA for clinical use in CLIA certified labs for the detection of SARS-CoV-2 RNA, the Linea™ COVID-19 assay kit has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31, 2020. The Linea™ COVID-19 assay kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The Linea™ COVID-19 assay kit has been authorized only for the detection of nucleic acids from SARS-CoV-2, not for any other virus or pathogen.

In addition, the use of the Linea™ COVID-19 assay kit is indicated for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens including nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal swabs and oropharyngeal swabs, nasopharyngeal wash/aspirate or nasal aspirates collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The Linea™ COVID-19 assay kit has been authorized only for the detection of nucleic acids from SARS-CoV-2, not for any other virus or pathogen.