COVID-19 Assay Kit Detects S-Gene Mutation Found in U.K. Variant

New York-based Applied DNA Sciences, Inc. announced that the U.S. FDA published a safety communication that identifies the Linea™ COVID-19 Assay Kit as one test-marketed under an Emergency Use Authorization that potentially identifies certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7).

Identifying certain virus mutations can help identify samples that should be further characterized by genetic sequencing and can potentially assist with the early detection of new SARS-CoV-2 variants in patients, which may reduce the further spread of infection and COVID-19 cases.

Dr. James A. Hayward, president, and CEO, Applied DNA, stated in a press release issued on January 8, 2021, “Using our Assay Kit, we have already identified variants of SARS-CoV-2 via S-gene dropout, sequenced the identified variants with partners and identified common genetic progenitors that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants. Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat.”

The Linea™ COVID-19 Assay Kit is authorized by FDA 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.