FDA reissues EUA for a COVID-19 assay kit for serial screening of asymptomatic individuals

May 13, 2021

Applied DNA Sciences, Inc. reported 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.

Dr. James A. Hayward, president and CEO, Applied DNA, said, “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.”

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 said, “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.”

Applied DNA Sciences has the release.

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