The US FDA lists the Linea ™ COVID-19 DNA test kit applied as one of 2 tests authorized by the EUA capable of detecting the S gene mutation found in the UK variant SARS-CoV-2 (B. 1.1.7)


– Early and cost-effective identification of samples potentially containing B.1.1.7 or other variants can help reduce the spread of infection –

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in the manufacture of DNA-based polymerase chain reaction (PCR), today announced that the Food and Drug Administration ( FDA) of the United States has issued a Safety Communication (the “Communication”) which identifies the Company’s Linea ™ COVID-19 test kit (the “Test Kit”) as one of only two tests marketed under the Emergency Use Clearance (EUA) from the FDA that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the UK variant of SARS-CoV-2 (B.1.1 .7). According to recent publications, the B.1.1.7 variant has been identified in the United States and may be associated with an increased risk of transmission of the virus responsible for COVID-19. Identifying certain mutations can help identify samples that should be further characterized by genetic sequencing and can potentially aid in the early detection of new variants in patients, which can reduce the spread of infection. The full text of the communication can be accessed via the URL below.

According to the communication, the FDA is monitoring the potential effects of genetic variation on molecular tests that have received EUA, including the company’s test kit. The communication notes that molecular tests designed to detect multiple genetic targets of SARS-CoV-2, such as the test kit, are less sensitive to the effects of genetic variation than tests designed to detect a single genetic target. Based on an analysis conducted by the Company and the FDA, one of the two S gene targets (S1 and S2) in the test kit has significantly reduced sensitivity in the presence of certain S gene mutations, including an mutation found in the B.1.1 .7 variant. The communication notes that the reduced susceptibility, also known as the S gene drop, may indicate certain mutations in SARS-CoV-2, including the B.1.1.7 variant. Due to the multi-target design of the test kit, the communication states that the overall sensitivity of the test kit should not be affected.

“Our ability to potentially identify certain variants of SARS-CoV-2 is based on the multi-target design of our test which mitigates the impact of an S gene mutation on test sensitivity. We believe our test kit may be of benefit to public health. officials and diagnostic laboratories, a rapid and cost-effective tool – whether through diagnostic testing or pooled surveillance – with which to potentially identify and track the spread of B.1.1.7 which is all the more difficult by the ‘Apparent advantage of variant inheritance,’ said Dr. James A. Hayward, President and CEO, Applied DNA. “Using our test kit, we have already identified variants of SARS-CoV-2 via S gene drop, sequenced the variants identified with partners and identified common genetic progenitors that are shared by B.1.1.7 and other SARS-CoV- Using this knowledge, we began to develop new tests to detect specific mutations in SARS-CoV-2 and to adapt our test to respond to the evolving threat of SARS-CoV-2. “

Link to FDA Safety Communication: -providers-and- clinical laboratory

About the Linea ™ COVID-19 Test Kit and Pooled Surveillance Tests

The Linea ™ COVID-19 Test Kit is cleared by the FDA EUA for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory specimens, including anterior nasal swabs, self-collected in a healthcare facility collected by a healthcare professional, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washings / aspirates or nasal aspirates and bronchoalveolar lavage (BAL) samples collected by a healthcare professional from persons suspected of COVID-19 by their healthcare professional. The scope of the Linea ™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use in accordance with the instructions for use of authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 ( CLIA) to perform high complexity tests. The EUA will be in effect until the declaration of the existence of circumstances justifying the authorization of the emergency use of in vitro diagnostics for the detection and / or diagnosis of COVID-19 is terminated or until ” prior termination or revocation of the EUA. The diagnostic kit has not been approved or approved by the FDA, and the EUA’s limited clearance is only for the detection of SARS-CoV-2 nucleic acid, not for any other virus or pathogen. .

The company offers surveillance tests that meet current CDC, FDA, and CMS guidelines. The use of saliva and pooled sampling for surveillance testing, which has been validated internally by the company according to current surveillance testing guidelines, is not included in the company’s EUA clearance for the Linea ™ COVID-19 test 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 preclinical nucleic acid therapeutic drug candidates.

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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 stock exchange under the symbol “APPDW”.

Applied DNA is a member of the Russell Microcap® Index.

Forward-looking statements

Statements made by Applied DNA in this press release may be “forward-looking” 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 of the test kit becoming obsolete or its usefulness diminished, 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 progress further through the preclinical research or clinical trial process, including by receiving clearance from the Food and Drug Administration (US FDA) or equivalent foreign regulatory agencies to conduct clinical trials if and when, if at all, they will receive final approval from the US FDA or other agencies foreign regulatory authorities, the unknown outcome of any inquiries or requests to the US FDA, equivalent foreign regulatory agencies, and / or New York State Department of Health, the unknown limited duration of any US FDA Emergency Use Authorization (EUA), changes in guidelines promulgated by the CDC, US FDA and / or CMS regarding COVID-19 monitoring 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 reports and filings with the SEC , 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 Applied DNA assumes no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unforeseen events, except as otherwise required by law.

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Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8814, [email protected]
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