Early and cost-effective identification of samples that potentially contain the B.1.1.7 or other variants can help reduce the further spread of infection –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the ‘company’), a leader in DNA manufacturing based on Polymerase Chain Reaction (PCR), announced today that the US Food and Drug Administration (FDA) has issued a safety statement (the “Communication”) which identifies the company’s Linea ™ COVID-19 Assay Kit (the “Assay Kit”) as one of only two tests marketed under the FDA’s Emergency Use Authorization (EUA) that could potentially identify SARS-CoV-2. mutations, including a mutation found in the British variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus causing COVID-19. The identification of certain mutations can help identify samples that need to be further characterized by genetic sequencing and could potentially help with the early detection of new variants in patients, which may further reduce the spread of infection. The full text of the communication is accessible via the URL below.
According to the communication, the FDA is monitoring the potential effects of genetic variation on molecular tests that EUA has received, including the company’s Assay Kit. The Communication notes that molecular assays designed to detect multiple SARS-CoV-2 genetic targets, such as the Assay Kit, are less susceptible to the effects of genetic variation than assays designed to target a single genetic target. to track. Based on the analysis conducted by the company and the FDA, one of the two S gene targets (S1 and S2) of the Assay Kit significantly reduced the sensitivity in the presence of certain S gene mutations, including ‘ a mutation found in B.1.1. .7 variant. The communication notes that the decreased sensitivity, also known as an S gene failure, may be an indication of certain SARS-CoV-2 mutations, including the B.1.1.7 variant. Due to the multi-purpose design of the Assay Kit, the communication states that the overall sensitivity of the Assay 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 that mitigates the impact of a mutation on the S gene on test sensitivity. We believe that our Assay Kit addresses public health “can provide officers and diagnostic laboratories is a fast and cost-effective tool – through diagnostic or aggregate monitoring tests – with which B.1.1.7 can identify and detect distribution that becomes all the more challenging due to the apparent transfer advantage of the variant,” said Dr. . James A. Hayward, President and CEO, applied DNA. Using our Assay Kit, we have already identified variants of SARS-CoV-2 via S gene failure, identified the variants with successive partners and common genetic progenitors shared by B.1.1.7 and other emerging SARS CoV- Two variants: Using this knowledge, we started to develop new tests to detect specific mutations in SARS-CoV-2 and to adapt our test to address the SARS-CoV-2 threat. “
Link to FDA safety communications: 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 compound testing for supervision
The Linea ™ COVID-19 Assay Kit has been approved by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory samples, including nasal swabs previously collected at a health care facility or collected by a healthcare professional, and nasopharyngeal and oropharyngeal and oropharyngeal swabs, mid-turbine nasal swabs, nasopharyngeal washes / aspirates or nasal aspirates, and bronchoalveolar lavage water (BAL) samples collected by a healthcare professional from individuals suspected by their healthcare provider of COVID-19. The scope of the Linea ™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use in accordance with the instructions for use by authorized laboratories, certified under the 1988 Clinical Laboratory Improvement Modifications (CLIA) to perform high complexity tests. The EUA shall remain in force until the declaration of existence, the authorization to use the in vitro diagnostic use for the detection and / or diagnosis of COVID-19 is justified, terminated or until the EUA is terminated or revoked in advance. The diagnostic kit has not been approved or approved by the FDA, 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 offers surveillance tests according to current CDC, FDA and CMS guidelines. The use of saliva and joint sampling for surveillance tests, which have been validated internally by the company in accordance with the current guidelines for testing surveillance, is not included in the 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 theft technology, genotyping of products and candidates for therapeutic drugs based on nucleic acid.
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The company’s ordinary shares are listed on NASDAQ under the symbol ‘APDN’ and the exchange-traded warrants are listed on 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 ‘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 Future judgments 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 may differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the test kit may become obsolete or reduce its usefulness, the uncertainties inherent in research and development, future clinical data. and analysis, including whether any of the applied DNAs or its partner’s diagnostic candidates will progress further in the preclinical examination or clinical trial process, including receiving US Food and Drug Administration (FDA) approval or equivalent foreign regulatory agencies to clinical perform tests if and when, if at all, they will receive the final approval of 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 the Department of Health in New York, the unknown limited duration of any US FDA Emergency Permit Approval, changes in guidelines promulgated by the CDC, US FDA and / or CMS regarding COVID-19 surveillance and diagnostic tests, interruptions in the provision of raw materials and supplies, and supplies own other factors set out from time to time in the Applied DNA’s SEC reports and files, including our annual report on Form 10-K submitted on December 17, 2020, and other reports we submit to the SEC, which are available is at www.sec.gov. Applied DNA undertakes no obligation to update prospective statements in public to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unexpected events, unless otherwise required by law.
Check out the source version on businesswire.com: https://www.businesswire.com/news/home/20210108005522/af/
Contacts
Investors contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8814, [email protected]
Web: www.adnas.com
Twitter: @APDN