Applied DNA Sciences (APDN) to Deploy Linea 1.0 COVID-19 Assay for Rapid Detection of New Omicron Subvariant BA.2

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), intends to deploy its Linea™ 1.0 COVID-19 Assay (the “Linea 1.0 Assay” or the “Assay”), part of ADCL’s Linea COVID-19 diagnostics and testing portfolio, for the rapid detection of samples containing a mutation profile that is indicative of the BA.2 subvariant (BA.2) of Omicron in COVID-19-positive samples.

ADCL believes the Linea 1.0 Assay has clinical utility as a genomic surveillance solution to enable public health authorities to detect and assess BA.2 spread via the reflex testing of COVID-19 positive samples with the Linea 1.0 Assay. When used as a reflex test, the Company believes the Linea 1.0 Assay allows for the rapid and inexpensive identification of positive COVID-19 samples that are indicative of BA.2 relative to costly and time-consuming next-generation sequencing.

First identified in November 2021, BA.2 is a descendant of the Omicron variant (BA.1) but differs in some of its genetic traits, including certain mutations in the spike protein, which may make it somewhat harder to detect via S-gene target failure (“SGTF") on certain third-party assays. SGTF was used globally to track the spread and prevalence of the Omicron variant (BA.1). In silico analysis of the BA.2 subvariant conducted by ADCL indicates that BA.2 will likely result in a unique detection signature on the Linea 1.0 Assay that is distinct from BA.1 and other currently circulating SARS-CoV-2 variants of concern and/or interest. The Linea 1.0 Assay’s ability to identify samples containing a mutation profile indicative of BA.2 via SGTF is possible due to the Assay’s unique double S-gene target design.

BA.2 has been identified in nearly 50 countries, including the U.S., U.K., Israel, and Denmark, where the subvariant accounts for almost half of Omicron cases. According to Denmark’s Statens Serum Institute, the country's top infectious disease authority, “preliminary calculations suggest BA.2 could be 1.5 times more infectious than BA.1.” On January 27, 2022, the New York State Health Department, the State in which most ADCL’s COVID-19 testing clients reside, confirmed its first cases of BA.2. The subvariant has been sequenced in at least 20 States.

“Deploying Linea 1.0 Assay towards BA.2 potentially positions ADCL for incremental testing demand while also offering clinical utility to epidemiologists presently analyzing BA.2 to determine its characteristics and their clinical significance to understand better how the subvariant might shape the nation’s pandemic response going forward. As a result of the Assay’s double S-gene target design, we believe public health officials can be ahead of the curve in case of BA.2 prevalence,” stated Dr. James A. Hayward, president and CEO of Applied DNA.

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