– Early and economical identification of samples that potentially contain B.1.1.7 or other variants can help to reduce the spread of infection –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in the manufacture of DNA based on the Polymerase Chain Reaction (PCR), today announced that the U.S. Food and Drug Administration (FDA) has published a safety communication (the “Communication”) that identifies the Company’s Linea ™ Test Kit COVID-19 (the “Test Kit”) as one of only two tests marketed under the FDA Emergency Use Authorization (USA) that are potentially capable of identifying certain SARS-CoV-2 mutations, including a mutation found in the United Kingdom variant of SARS-CoV-2 (B.1.1.7). According to recent publications, variant B.1.1.7 has been identified in the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19. The identification of certain mutations can help to identify samples that must be further characterized by means of genetic sequencing and can assist in the early detection of new variants in patients, which can reduce the spread of the infection. The full text of the Communication can be accessed at the URL below.
According to the communication, the FDA monitors the potential effects of genetic variation in molecular tests that have received USA, including the company’s test kit. The communication notes that molecular tests designed to detect multiple SARS-CoV-2 genetic targets, such as the test kit, are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target. Based on the analysis conducted by the Company and FDA, one of the two targets of the S gene (S1 and S2) in the assay kit significantly reduced sensitivity in the presence of certain mutations of the S gene, including a mutation found in B.1.1 .7 variant . The Communication notes that reduced sensitivity, also known as abandonment of the S gene, may be indicative of certain SARS-CoV-2 mutations, including variant B.1.1.7. Due to the Assay Kit’s multiple target design, the communication states that the Assay Kit’s overall sensitivity should not be affected.
“Our ability to potentially identify certain variants of SARS-CoV-2 is based on the multiple target design of our assay that mitigates the impact of a mutation in the S gene on the sensitivity of the test. We believe that our assay kit can give public health officials and diagnostic labs a fast and economical tool – whether through diagnostic or cluster surveillance testing – with which to potentially identify and track the spread of B.1.1.7 which is made even more challenging by the apparent transmission advantage of the ” , said Dr. James A. Hayward, president and CEO of Applied DNA. “Using our Assay Kit, we have already identified variants of SARS-CoV-2 via elimination of the S gene, sequenced the variants identified with partners and identified common genetic parents that are shared by B.1.1.7 and other emerging SARS-CoV-2 Using this knowledge, we began to develop new assays to detect specific mutations in SARS-CoV-2 and adapt our assay to address the evolving threat of SARS-CoV-2. “
Link to FDA safety communication: https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers -and- clinical laboratory
About the Linea ™ COVID-19 test kit and pooled surveillance test
The Linea ™ COVID-19 Assay Kit is authorized by the US FDA for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory samples, including anterior nasal swabs, self-collected at a health facility or collected by a healthcare professional , and nasopharyngeal and oropharyngeal swabs, medium concha nasal swabs, nasopharyngeal or nasal aspirate washes / samples and bronchoalveolar lavage (BAL) samples collected by a health professional from individuals suspected of having COVID-19 by their health provider. The scope of the Linea ™ COVID-19 Assay Kit USA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments 1988 (CLIA) for conducting highly complex tests . EUA will remain in effect until the statement of circumstances that justify the authorization of the emergency use of in vitro diagnostics for detection and / or diagnosis of COVID-19 or until the prior termination or revocation of EUA. The diagnostic kit has not been released or approved by the FDA, and the limited authorization from the USA is only for the detection of SARS-CoV-2 nucleic acid, not for any other viruses or pathogens.
The company is offering surveillance tests in compliance with current CDC, FDA and CMS guidelines. The use of saliva and joint sampling for surveillance testing, which has been validated internally by the Company in accordance with current surveillance testing guidelines, is not included in the Company’s US authorization for the Linea ™ COVID-19 Test Kit.
On Science Applied to DNA
Applied DNA is a supplier of molecular technologies that enable the security of the supply chain, anti-counterfeiting and anti-theft technology, product genotyping and candidates for therapeutic drugs based on preclinical acid.
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The company’s common shares are listed on the NASDAQ under the symbol ‘APDN’, and its publicly traded warrants are listed on the OTC under the 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 of a “forward-looking” nature in accordance with 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 Applied DNA’s control. Actual results may differ materially from those projected due to their history of net losses, limited financial resources, limited market acceptance, the possibility that the test kit may become obsolete or have its usefulness 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 authorization from the Food and Drug Administration (US FDA) or equivalent foreign regulatory agencies to conduct clinical trials and if and when they are received, they will receive final approval from the US FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to the US FDA, equivalent foreign regulatory agencies and / or New York State Department of Health, the duration limits from the unknown of any US FDA emergency use approval approval (USA), changes to the guidelines promulgated by the US CDC, FDA and / or CMS regarding COVID-19 surveillance and diagnostic tests, interruptions in the supply of materials and supplies and several 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 that we filed with the SEC, which are available at www.sec.gov. Applied DNA assumes no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date of this document or to reflect the occurrence of unforeseen events, unless otherwise required by law.
See the source version at businesswire.com: https://www.businesswire.com/news/home/20210108005522/en/
Contacts
Investor contact: Sanjay M.urry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8814, [email protected]
Network: www.adnas.com
Twitter: @APDN