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

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COVID-19 Assay Kit for Asymptomatic Screening of Individuals with Serial Testing: Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company’s Linea™ COVID-19 Assay Kit (the “Assay Kit”) a re-issued Emergency Use Authorization (EUA) that expands the Assay Kit’s intended use to include serial screening of asymptomatic individuals.

The expanded intended use allows for the serial testing of individuals with or without symptoms, eliminates the prescription requirement, and returns results to individuals. With the recent receipt of CLIA certification by its Applied DNA Clinical Labs, LLC (ADCL) subsidiary, the expanded intended use enables the Company to now offer recurring testing strategies with individual result reporting without a prescription to support the safer reopening of schools, workplaces, nursing homes and skilled nursing facilities, and other places where people gather regularly in numbers. The Assay Kit with its expanded intended use is also available for immediate purchase by CLIA-certified laboratories nationally.

“The expanded intended use for our Assay Kit supports our systematic approach to expanding the addressable market for our COVID-19 testing services and Assay Kit that is aligned with COVID-19 ‘normalization’ strategies and funding sources aimed at reopening the economy,” said Dr. James A. Hayward, president and CEO, Applied DNA. “The ability to return results to the individual and the elimination of the prescription requirement, we believe, substantially differentiates ADCL’s services in the testing market and elevates the value of our Assay Kit to clinical laboratories that can now bring to bear our high sensitivity PCR-based test – still the gold standard for COVID-19 diagnostics – to help prevent people with asymptomatic infections from turning into unsuspecting super-spreaders. We are further characterized by the ability of our Assay Kit to discriminate some variants. We believe that a rigorous serial testing program is the most effective way to confirm current COVID-19 status as part of any reopening strategy.

“As access to vaccines expands and certain COVID-19-related restrictions are eased, the confluence of vaccinated, under-vaccinated, vaccine ineligible, or otherwise immune-compromised populations, particularly in such mixed settings as skilled nursing facilities where staff and patients interact, makes asymptomatic serial testing more relevant to at-risk populations. Asymptomatic serial testing, together with a greater testing throughput afforded to us and those CLIA-certified laboratories that purchase our Assay kits that now are authorized for additional robotic automation, makes our Assay Kit a compelling solution to support the nation’s effort to reopen and limit wild-type and variant viral spread.”

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 safeCircleTM, 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.

 

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