Research & Development
FDA Grants EUA to Applied DNA Linea COVID-19 Assay Kit for Asymptomatic Screening of Individuals with Serial Testing
12 May 2021 - - The US Food and Drug Administration has granted US-based DNA manufacturing company Applied DNA Sciences, Inc's (NASDAQ: APDN) 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.

With the recent receipt of CLIA certification by its Applied DNA Clinical Labs, LLC 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.

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.

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 textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

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, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.

The test is also intended for use with anterior nasal swab specimens that are self-collected in the presence of an HCP from individuals without symptoms or other reasons to suspect COVID-19 when tested at least weekly and with no more than 168 hours between serially collected specimens.

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.

The 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.

The company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances.

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