Applied DNA Receives FDA Emergency Use Authorization for COVID-19 Diagnostic Assay Kit
Advanced Single Well Assay Designed for High-Throughput Testing
STONY BROOK, N.Y. – May 14, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company,” “our”) 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.”
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.
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.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
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The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners diagnostic or therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications to U.S. FDA or equivalent foreign regulatory agencies, the unknown duration of this or any EUA approval, disruptions in the supply of raw material and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
