STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), right this moment clarifies the scope of its newly licensed asymptomatic serial screening indication for its Linea COVID-19 Assay Kit (the “Assay Kit”) and sure data contained in its beforehand disseminated 12 May 2021 press launch (the “Press Release”) regarding the U.S. Food and Drug Administration’s (FDA) grant of a re-issued Emergency Use Authorization (EUA) that expands the Assay Kit for asymptomatic serial screening testing.
The Company clarifies that in step with the Assay Kit’s prescription use solely labeling, whereas a person testing topic doesn’t have to acquire a person prescription from their healthcare supplier for asymptomatic serial screening testing with the Assay Kit, a blanket prescription from a healthcare supplier overlaying the person being examined is critical to adjust to all regulatory necessities regarding the Assay Kit.
Regarding asymptomatic serial screening testing with the Assay Kit by the Company’s wholly owned scientific laboratory subsidiary Applied DNA Clinical Laboratories, LLC (“ADCL”), if an asymptomatic serial screening testing consumer can not present a blanket prescription from a healthcare supplier, ADCL plans to interact healthcare suppliers to work with shoppers to acquire the required blanket prescriptions. The Company believes this course of shall be seamless for its testing clients whereas nonetheless complying with all regulatory necessities regarding the usage of the Assay Kit.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain response (“PCR”)-based manufacturing platform that permits for the large-scale manufacturing of particular DNA sequences.
The LinearDNA platform has utility within the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug improvement and manufacturing market. The platform is used to fabricate DNA for clients as elements of in vitro diagnostic exams and for preclinical nucleic acid-based drug improvement within the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and most cancers), RNA therapies, clustered frequently interspaced brief palindromic repeats (CRISPR) primarily based therapies, and gene therapies. Applied DNA has additionally established a COVID-19 diagnostic and testing providing that’s within the early levels of commercialization and is grounded within the Company’s deep experience in DNA.
The LinearDNA platform additionally has non-biologic functions, comparable to provide chain safety, anti-counterfeiting and anti-theft expertise. Key end-markets embrace Gov/Mil, textiles, prescribed drugs and nutraceuticals, and hashish, amongst others.
The Company’s widespread inventory is listed on NASDAQ beneath ticker image ‘APDN,’ and its publicly traded warrants are listed on OTC beneath ticker image ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
About the Linea™ COVID-19 Assay Kit
The Linea™ COVID-19 Assay Kit is a real-time RT-PCR take a look at supposed for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens together with anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare employee, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare employee from people who’re suspected of COVID-19 by their healthcare supplier (HCP). The take a look at can be supposed for use with anterior nasal swab specimens which can be self-collected within the presence of an HCP from people with out signs or different causes to suspect COVID-19 when examined not less than weekly and with not more than 168 hours between serially collected specimens.
The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly restricted to make use of in step with the Instructions for Use by licensed laboratories, licensed beneath the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to carry out excessive complexity exams. The EUA shall be efficient till the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or analysis of COVID-19 is terminated or till the EUA’s prior termination or revocation. The diagnostic package has not been FDA cleared or authorized, and the EUA’s restricted authorization is barely for the detection of nucleic acid from SARS-CoV-2, not for another viruses or pathogens.
The Company is providing surveillance testing in compliance with present CDC, FDA, and CMS steerage. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with present surveillance testing steerage, isn’t included within the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
The statements made by Applied DNA on this press launch could also be “forward-looking” in nature inside the which means 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, methods, and expectations, and are primarily based on assumptions and contain numerous dangers and uncertainties, lots of that are past the management of Applied DNA. Actual outcomes might differ materially from these projected because of its historical past of internet losses, restricted monetary sources, restricted market acceptance, the likelihood that the assay package might develop into out of date or have its utility diminished, the uncertainties inherent in analysis and improvement, future scientific information and evaluation, together with whether or not any of Applied DNA’s or its associate’s diagnostic candidates will advance additional within the preclinical analysis or scientific trial course of, together with receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equal international regulatory companies to conduct scientific trials and whether or not and when, if in any respect, they may obtain remaining approval from the U.S. FDA or equal international regulatory companies, the unknown final result of any functions or requests to U.S. FDA, equal international regulatory companies and/or the New York State Department of Health, the unknown restricted length of any Emergency Use Authorization (EUA) approval from U.S. FDA, adjustments in steerage promulgated by the CDC, U.S. FDA and/or CMS regarding COVID-19 surveillance and diagnostic testing, disruptions within the provide of uncooked supplies and provides, and varied different components detailed every so often in Applied DNA’s SEC studies and filings, together with our Annual Report on Form 10-Okay filed on December 17, 2020, and Quarterly Reports on Form 10-Q filed on February 11, 2021 and May 13, 2021, and different studies we file with the SEC, which can be found at www.sec.gov. Applied DNA undertakes no obligation to replace publicly any forward-looking statements to mirror new data, occasions or circumstances after the date hereof or to mirror the prevalence of unanticipated occasions, except in any other case required by regulation.