FDA Grants EUA to Applied DNA LineaTM COVID-19 Assay Kit for Asymptomatic Screening of Individuals with Serial Testing - Seite 2

Under the re-issued EUA, serial testing of asymptomatic individuals for SARS-CoV-2 requires individuals to be tested weekly and with no more than seven days (168 hours) between serially collected specimens. The re-issued EUA also further expands the addressable market for the screening or diagnostic use of the Assay Kit by authorizing the use of the KingFisher Flex Purification System, a high-throughput robotic nucleic acid extraction system in wide use by CLIA-certified laboratories nationally. With the addition of the KingFisher system to the EUA, ADCL will have a daily testing capacity of several thousand COVID-19 samples.

Dr. Hayward concluded, “The expanded intended use is also complementary to safeCircle^TM, our pooled surveillance COVID-19 testing platform. Together with CLIA certification, we can now offer clients the choice between conventional physician-ordered diagnostic testing, non-pooled individual screening testing, and pooled surveillance testing, thereby allowing us to provide a range of COVID-19 testing programs that can be tailored to meet the unique testing requirements of a diverse range of clients.”

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.

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

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The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’

Applied DNA is a member of the Russell Microcap Index.