Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that it has secured a blanket purchase order from an existing customer for its Linea™ COVID-19 Assay Kit (the "Assay Kit") and consumables to conduct 10,000 tests. The Company has already shipped a portion of the purchase order in the current fiscal quarter ending December 31, 2020. The balance of the purchase order is expected to be delivered in the current quarter. The Company anticipates recurring purchase orders for Assay Kits and consumables from the customer.
The Assay Kit may be used for pooled surveillance testing by non-CLIA and CLIA certified laboratories or by CLIA-certified laboratories for molecular diagnostic testing. The Assay Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for use as a molecular diagnostic test in May 2020. Pursuant to the EUA, the Assay Kit is authorized for use by CLIA-certified laboratories in the United States for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.
The Assay Kit is authorized to run on ThermoFisher Scientific’s QuantStudio™ Dx Real-Time PCR Instrument and QuantStudio™ 5 Real-Time PCR System under an amendment to its EUA. Each PCR device is capable of performing 400 to 800 tests in a 24-hour period. The Company has applied for an additional amendment to its EUA that would extend the authorized use of its Assay Kit to ThermoFisher Scientific’s Applied Biosystems™ 7500 Real-Time PCR System, a widely used RT-PCR system that has the capacity to perform a similar number of tests to the QuantStudio 5 and QuantStudio Dx in a 24-hour period.
About the Linea™ COVID-19 Assay Kit
The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.
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’.
Applied DNA is a member of the Russell Microcap® Index.
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, 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 partner’s diagnostic 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 or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, FDA and/or CMS, disruptions in the supply of raw materials 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 reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 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.
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Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, email@example.com
Program contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, firstname.lastname@example.org