Applied DNA Linea™ COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing
Applied DNA Sciences (NASDAQ: APDN) announced that its Linea™ COVID-19 Assay Kit successfully identified COVID-19 variants, including the U.K. variant B.1.1.7, via S-gene dropout. This detection is part of the Company’s safeCircle™ pooled surveillance testing service. The Assay Kit received FDA EUA for identifying SARS-CoV-2 in various respiratory specimens. The Company emphasizes the importance of utilizing its Assay Kit for early detection of new variants to aid in controlling COVID-19 spread. The testing method showcases a multi-target design, maintaining sensitivity even for variant-infected samples.
- Successful identification of COVID-19 variants using the Linea™ Assay Kit.
- FDA EUA authorization for the Assay Kit enhances market trust.
- Multi-target design ensures detection sensitivity for variants.
- Potential obsolescence of the Assay Kit as testing methods evolve.
- Dependence on Emergency Use Authorization raises regulatory risks.
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea™ COVID-19 Assay Kit (the “Assay Kit”) identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in the pandemic until now. The variants were identified as part of the Company’s safeCircleTM pooled surveillance testing service, which is powered by the Company’s Assay Kits. The Assay Kits are also available for diagnostic use in third-party laboratories certified for complex molecular diagnostics.
Beginning in December 2020, the Assay Kit identified multiple instances of COVID-19 positive individuals whose samples evidenced a specific S-gene mutation known as 69-70 deletion (69-70del). Detection of samples carrying 69-70del with the Assay Kit is accomplished via S-gene dropout observed in one of the two Assay Kit’s SARS-CoV-2 genetic targets. Gene sequencing methods confirmed the variants identified by the Assay Kit. The 69-70del mutation is found in several variants, including B.1.1.7, also known as the U.K. variant, that is characterized by increased transmissibility.
Dr. James Hayward, president and CEO of Applied DNA, stated: “We believe that a testing strategy that is grounded in its use of our Assay Kit should be considered by any community, company, government or organization that wants to surveil their cohorts for the presence of new variants, detect them early, and take steps to contain them. Our Assay Kit is available immediately for any certified diagnostic lab or surveillance program.”
As announced on January 8, 2021, the U.S. Food and Drug Administration announced that the Company’s Assay Kit was one of a select few molecular diagnostics that could potentially identify SARS-CoV-2 variants that contain a specific S-gene (that encodes for Spike protein) mutation known as 69-70del. Due to the Assay Kit’s multi-target design, the overall sensitivity of the Assay Kit is not impacted, and a positive result is still obtained for variant-infected samples.
The virus that causes COVID-19, SARS-CoV-2, is prone to mutate over time, especially within patients who remain chronically infected over months, resulting in genetic variations in the population of circulating viral strains. Concern has been building among scientists that new variants will dominate in American infections by Spring, a challenge exacerbated by the inability of the vast majority of PCR and antigen tests to specifically detect these variants. The recent detection of multiple variants via S-gene dropout with the Assay Kit highlights the importance of utilizing a molecular diagnostic assay that can easily and cost-effectively identify potential variants. The Company believes that the identification of variants, especially the more transmissible U.K. (B.1.1.7) and new variants from other phylogenetic paths, is essential to containing the spread of COVID-19.
About the LineaTM COVID-19 Assay Kit and Pooled Surveillance Testing
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.
To learn more about the Linea™ COVID-19 Assay Kit: https://adnas.com/dxcovid/
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.
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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 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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FAQ
What variants did the Linea™ COVID-19 Assay Kit identify?
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How does the Assay Kit contribute to COVID-19 variant surveillance?
