Applied DNA Receives Blanket Purchase Order for Linea™ COVID-19 Assay Kits for 10,000 Tests
Applied DNA Sciences (NASDAQ: APDN) announced a purchase order for its Linea™ COVID-19 Assay Kit to conduct 10,000 tests under a Master Services Agreement. The delivery is expected primarily in the fiscal quarter ending March 31, 2021. The Assay Kit is authorized under the FDA's Emergency Use Authorization and can detect certain SARS-CoV-2 mutations. The company views this order as validation of the kit's effectiveness amid rising vaccination rates and the spread of COVID-19 variants, specifically the U.K. variant.
- Received purchase order for 10,000 tests, indicating strong customer demand.
- Assay Kit recognized by FDA for its ability to detect specific SARS-CoV-2 mutations.
- Potential risks due to the declining utility of the Assay Kit as variants evolve.
- Dependence on emergency use authorization which could be revoked.
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced the receipt of a purchase order for its Linea™ COVID-19 Assay Kit (the “Assay Kit”) and consumables to conduct 10,000 tests under a Master Services Agreement with an existing customer. The Company expects to deliver most of the purchase order in the current fiscal quarter ending March 31, 2021 with the balance to be delivered in the following fiscal quarter. This blanket purchase order represents the third such order from the customer for the purpose of conducting pooled COVID-19 surveillance testing.
In January 2021, the U.S. Food and Drug Administration published a safety communication that identified the Company’s Assay Kit as one of a limited number of molecular diagnostics marketed under the FDA’s Emergency Use Authorization (EUA) that are potentially able to discriminate certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). The Company believes that its Assay Kit can give public health officials, diagnostic laboratories, and pooled surveillance testing customers a fast and cost-efficient tool – whether through diagnostic or pooled surveillance testing – with which to potentially screen for and track B.1.1.7 spread that is made more challenging by the variant’s apparent transmission advantage.
“This latest order is an endorsement of the enduring utility of our Assay Kit in a testing environment simultaneously experiencing rising vaccination rates and growing COVID-19 variants spread with their potential to escape vaccine-induced immunity,” stated Dr. James A. Hayward, president and CEO, Applied DNA. “The use of our Assay Kit as a diagnostic test or in a pooled surveillance testing modality, as is the case with this customer and our safeCircle™ service, serves as an effective, complementary layer of protection as reopenings bring into close contact both vaccinated and unvaccinated populations at a time when community transmission remains a leading cause of virus spread. With fully
Footnotes:
1 https://www.nbcnewyork.com/news/coronavirus/all-new-yorkers-age-60-can-now-get-covid-vaccines-pharmacies-gain-bigger-role/2934602/
2 https://www.reuters.com/article/uk-health-coronavirus-variant-britain/uk-covid-19-variant-has-significantly-higher-death-rate-study-finds-idUSKBN2B212Q
About the Linea™ COVID-19 Assay Kit
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA 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 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 saliva and 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 commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
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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’.
Applied DNA is a member of the Russell Microcap® Index.
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 its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, 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 (U.S. FDA) 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, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, 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 17, 2020, and Form 10-Q filed on February 11, 2021 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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