Research & Development
Applied DNA Receives CLIA Certification, Enabling High Throughput Diagnostic COVID-19 Testing
11 May 2021 - - US-based DNA manufacturing Applied DNA Sciences, Inc's (NASDAQ: APDN) Applied DNA Clinical Labs, LLC subsidiary received CLIA (Clinical Laboratory Improvement Amendments) certification from the New York State Department of Health Clinical Laboratory Evaluation Program for COVID-19 testing using EUA-authorized methods and devices, the company said.

With this certification, ADCL can now serve as a diagnostic laboratory to conduct high throughput diagnostic COVID-19 testing utilizing EUA-authorized testing platforms, including the company's Linea COVID-19 Assay Kit.

ADCL's CLIA certification umbrella includes its Ltd. Service Laboratory certification for Point-of-Care testing using COVID-19 molecular and antigen assays and community screening applications for COVID-19 and influenza.

With certification, ADCL can now pursue diagnostic COVID-19 testing for regional healthcare providers and overflow business from third-party and hospital clinical labs.

Certification will also allow ADCL to capture a greater percentage of the economics of its safeCircle service by conducting confirmatory diagnostic testing in-house.

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 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.

ADCL's pooled surveillance testing program, 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.

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 Gov/Mil, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
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