Applied DNA Linea COVID-19 Assay Kit Demonstrates Effectiveness with Detection of Multiple SARS-CoV-2 Variants During Recent Surveillance Testing
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today 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 safeCircleTM 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.
Dr. James Hayward, president and CEO of Applied DNA, stated: “We believe that a testing strategy that is grounded in its use of our Assay Kit should be considered by any community, company, government or organization that wants to surveil their cohorts for the presence of new variants, detect them early, and take steps to contain them. Our Assay Kit is available immediately for any certified diagnostic lab or surveillance program.”
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.