Applied DNA Provides Clarification on Newly Authorized Asymptomatic Serial Screening Indication for LineaTM COVID-19 Assay Kit and Press Release Published 12 May 2021
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), today clarifies the scope of its newly authorized asymptomatic serial screening indication for its Linea COVID-19 Assay Kit (the “Assay Kit”) and certain information contained in its previously disseminated 12 May 2021 press release (the “Press Release”) relating to 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 consistent with the Assay Kit’s prescription use only labeling, while an individual testing subject does not need to obtain an individual prescription from their healthcare provider for asymptomatic serial screening testing with the Assay Kit, a blanket prescription from a healthcare provider covering the individual being tested is necessary to comply with all regulatory requirements relating to the Assay Kit.
Regarding asymptomatic serial screening testing with the Assay Kit by the Company’s wholly owned clinical laboratory subsidiary Applied DNA Clinical Laboratories, LLC (“ADCL”), if an asymptomatic serial screening testing client cannot provide a blanket prescription from a healthcare provider, ADCL plans to engage healthcare providers to work with clients to obtain the necessary blanket prescriptions. The Company believes this process will be seamless for its testing customers while still complying with all regulatory requirements relating to the use of the Assay Kit.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.