Research & Development
Applied DNA Sciences receives re-issued EUA for Linea COVID-19 Assay Kit to include serial screening of asymptomatic individuals
13 May 2021 -

PCR-based DNA manufacturing company Applied DNA Sciences Inc (NASDAQ:APDN) reported on Wednesday that the US Food and Drug Administration (FDA) has re-issued Emergency Use Authorization (EUA) for its Linea COVID-19 Assay Kit to include serial screening of asymptomatic individuals.

This is expected to support the safer reopening of schools, workplaces, nursing homes and other facilities.

The Linea COVID-19 Assay Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens including anterior nasal swabs, nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates and bronchoalveolar lavage (BAL) specimens.

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 between serially collected specimens. The 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.



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