Research & Development
Applied DNA Expands Addressable Market for Linea COVID-19 Assay Kit via Amendment to FDA EUA
25 November 2020 - - The US Food and Drug Administration has granted an Emergency Use Authorization amendment that expands the installed base of RT-PCR platforms that can process US-based DNA manufacturing specialist Applied DNA Sciences, Inc's (NASDAQ: APDN) Linea COVID-19 Assay Kit, the company said.

The EUA amendment extends the RT-PCR platform authorization from Applied Biosystems' (ThermoFisher Scientific) QuantStudio Dx and QuantStudio 5 Real-Time PCR systems to include Applied Biosystems 7500 Fast Dx Real-Time PCR System (ABI 7500).

The ABI 7500 has the capacity to perform 400 800 tests in 24 hours and is found in the majority of clinical laboratories nationally.

Separately, the company announced that an inspection report from the State of New York Department of Health following the DoH's initial inspection of Applied DNA Clinical Laboratories, LLC on October 7, 2020, highlighted deficiencies in ADCL's clinical standard of practice at the time of inspection that require remediation prior to the submission of a re-inspection request.

The company expects to complete remediation actions during the first calendar quarter of 2021.

In the interim, ADCL's safeCircle platform, its pooled COVID-19 surveillance testing program that does not require CLEP-CLIA certifications, is leveraging infrastructure designated for diagnostic testing to support safeCircle clients and Applied DNA's internal surveillance testing program for employees.

ADCL's pooled surveillance testing platform, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

The Linea COVID-19 Assay Kit is authorized by FDA EUA 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 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 pooled surveillance testing in compliance with current CDC, FDA, and CMS guidances.

The use of 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.

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.