Applied DNA Sciences, Inc. Announces Linea COVID-19 Assay Kit
January 19, 2021 at 12:00 pm
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Applied DNA Sciences, Inc. announced that its Linea COVID-19 Assay Kit (the “Assay Kit”) identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in the pandemic until now. The variants were identified as part of the Company’s safeCircle pooled surveillance testing service, which is powered by the Company’s Assay Kits. The Assay Kits are also available for diagnostic use in third-party laboratories certified for complex molecular diagnostics. Beginning in December 2020, the Assay Kit identified multiple instances of COVID-19 positive individuals whose samples evidenced a specific S-gene mutation known as 69-70 deletion (69-70del). Detection of samples carrying 69-70del with the Assay Kit is accomplished via S-gene dropout observed in one of the two Assay Kit’s SARS-CoV-2 genetic targets. Gene sequencing methods confirmed the variants identified by the Assay Kit. The 69-70del mutation is found in several variants, including B.1.1.7, also known as the U.K. variant, that is characterized by increased transmissibility. As announced on January 8, 2021, the U.S. Food and Drug Administration announced that the Company’s Assay Kit was one of a select few molecular diagnostics that could potentially identify SARS-CoV-2 variants that contain a specific S-gene (that encodes for Spike protein) mutation known as 69-70del. Due to the Assay Kit’s multi-target design, the overall sensitivity of the Assay Kit is not impacted, and a positive result is still obtained for variant-infected samples. The virus that causes COVID-19, SARS-CoV-2, is prone to mutate over time, especially within patients who remain chronically infected over months, resulting in genetic variations in the population of circulating viral strains. Concern has been building among scientists that new variants will dominate in American infections by Spring, a challenge exacerbated by the inability of the vast majority of PCR and antigen tests to specifically detect these variants. The recent detection of multiple variants via S-gene dropout with the Assay Kit highlights the importance of utilizing a molecular diagnostic assay that can easily and cost-effectively identify potential variants. The Company believes that the identification of variants, especially the more transmissible U.K. (B.1.1.7) and new variants from other phylogenetic paths, is essential to containing the spread of COVID-19.
Applied DNA Sciences, Inc. is a biotechnology company that develops, and markets deoxyribonucleic acid (DNA) based technology solutions. The Company is utilizing its LinearDNA large-scale polymerase chain reaction (PCR) based manufacturing platform. The Companyâs proprietary platform produces large quantities of DNA for use in the nucleic acid-based in vitro diagnostics and preclinical nucleic-acid based drug development and manufacturing markets and for supply chain security, anti-counterfeiting and anti-theft technology purposes. It also develops PCR-based molecular in vitro diagnostics for covid-19. In addition, under its wholly owned subsidiary, Applied DNA Clinical Labs, LLC, the Company is offering a high-throughput turnkey solution for population-scale Covid-19 testing marketed as safeCircle. safeCircle utilizes the Companyâs Covid-19 Diagnostic Tests and is designed to look for infection within defined populations or communities utilizing high throughput testing methodologies.