Research & Development
US FDA Lists Applied DNA's Linea COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 UK Variant
8 January 2021 - - The US Food and Drug Administration published a safety communication that identifies the company's Linea COVID-19 Assay Kit as one of only two tests marketed under the FDA's Emergency Use Authorization that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the UK variant of SARS-CoV-2, US-based DNA manufacturing company Applied DNA Sciences, Inc. (NASDAQ: APDN) said.

According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19.

The identification of certain mutations can help identify samples that should be further characterized via genetic sequencing and can potentially assist with the early detection of new variants in patients, which may reduce further spread of infection. The full text of the Communication is accessible via the URL below.

According to the Communication, the FDA monitors the potential effects of genetic variation on molecular tests that have received EUA, including the company's Assay Kit.

The Communication notes that molecular tests designed to detect multiple SARS-CoV-2 genetic targets, such as the Assay Kit, are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target.

Based on analysis conducted by the company and FDA, one of the two S-gene targets (S1 and S2) of the Assay Kit has significantly reduced sensitivity in the presence of certain S-gene mutations, including a mutation found in the B.1.1.7 variant.

The Communication notes that the reduced sensitivity, also known as an S-gene dropout, may be indicative of certain SARS-CoV-2 mutations, including the B.1.1.7 variant. Due to the Assay Kit's multi-target design, the Communication states the Assay Kit's overall sensitivity should not be impacted.

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.

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.