Applied DNA Strategy to Address Omicron

  Linea™ COVID-19 Assay Kit Likely Subject to Unique Double S-Gene Target Drop, Enables Rapid Reflex Testing of Positive Samples to Confirm Probable Presence of Omicron Without Sequencing -

- Company to Submit Validation Data to New York Department of Health for Linea™ 2.0 Assay to Service All safeCircle™ Customers in the Event of Omicron Prevalence -

Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, today announced its COVID-19 diagnostic strategy in response to the emergence of Omicron (B.1.1.529), a newly identified SARS-CoV-2 variant of concern. The Company plans to introduce its Linea™ 2.0 COVID-19 Assay ("Linea 2.0"), a new RT-PCR assay for the SARS-CoV-2 E and N genes that builds on the Company’s established COVID-19 line of diagnostics, after submission of its validation data to the New York State Department of Health (NYSDOH) in the next few days.

The Company also announced that its EUA-authorized Linea™ COVID-19 Assay Kit (the "Linea 1.0 Assay") likely exhibits a unique double S-gene target failure (or "drop") (SGTF) specific to the Omicron variant. While other assays have been shown to have SGTF based on the presence of the Δ69-70 mutation contained in Omicron, this specific mutation is shared across several SARS-CoV-2 lineages and is not specific to the new variant. Based on the Company’s initial analysis, the Company believes that the combination of mutations that cause the unique double SGTF in the Linea 1.0 Assay is unique to Omicron. This unique double SGTF may result in false negative results in patients infected with the Omicron variant when tested with the Linea 1.0 Assay as a primary diagnostic. This unique pattern may, however, allow the Linea 1.0 Assay to provide a high-specificity reflex test for the Omicron variant. More specifically, the Linea 1.0 Assay may be potentially used as a reflex test to indicate the presence of Omicron in samples that have tested positive for COVID-19 via third-party assays that cannot discriminate for the new variant because these same samples will test negative on the Linea 1.0 Assay due to the unique double SGTF.

https://finance.yahoo.com/news/applied-dna-announces-strategy-address-110000278.html