14 May 2021 - - US-based DNA manufacturing company Applied DNA Sciences, Inc. (NASDAQ: APDN) has clarified the scope of its newly authorized asymptomatic serial screening indication for its Linea COVID-19 Assay Kit and certain information contained in its previously reported 12 May release relating to the US Food and Drug Administration's grant of a re-issued Emergency Use Authorization that expands the Assay Kit for asymptomatic serial screening testing, the company said.

In that release, Applied DNA Sciences reported that The US Food and Drug Administration granted Applied DNA Sciences, Inc's Linea COVID-19 Assay Kit a re-issued Emergency Use Authorization that expands the Assay Kit's intended use to include serial screening of asymptomatic individuals, the company said.

The expanded intended use allows for the serial testing of individuals with or without symptoms, eliminates the prescription requirement, and returns results to individuals, the company said on 12 May.

Applied DNA Sciences now 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, 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.

Applied DNA is commercializing LinearDNA, its proprietary, large-scale polymerase chain reaction-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.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include Gov/Mil, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

The scope of the Linea COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests.

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA's prior termination or revocation.

The diagnostic kit has not been FDA cleared or approved, 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.

Applied DNA is offering surveillance testing in compliance with current CDC, FDA, and CMS guidance. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the company in compliance with current surveillance testing guidance, is not included in the company's EUA authorization for the Linea COVID-19 Assay Kit.