Applied DNA  deploys Linea 1.0 COVID-19 Assay for Rapid Detection of New Omicron Subvariant BA.2 

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Applied DNA Sciences, a leader in PCR-based DNA manufacturing and nucleic acid-based technologies, announced on Friday that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), plans to use its Linea 1.0 COVID-19 Assay (the “Linea 1.0 Assay” or the “Assay”), which is part of ADCL’s Linea COVID-19 diagnostics and testing portfolio, to detect samples with a mutation profile that is indicative of HIV

The Linea 1.0 Assay, according to ADCL, has clinical relevance as a genomic monitoring system, allowing public health authorities to detect and analyze BA.2 spread via reflex testing of COVID-19 positive samples. In comparison to costly and time-consuming next-generation sequencing, the Company believes the Linea 1.0 Assay enables the speedy and inexpensive identification of positive COVID-19 samples that are indicative of BA.2 when used as a reflex test.

BA.2 is a descendent of the Omicron variety (BA.1) but differs in some genetic features, such as specific spike protein mutations, which may make it more difficult to detect using S-gene target failure (“SGTF”) on certain third-party assays. SGTF was used to trace the spread and prevalence of the Omicron variation around the world (BA.1). According to ADCL’s in silico research of the BA.2 subvariant, BA.2 will most likely result in a distinct detection signature on the Linea 1.0 Assay from BA.1 and other currently circulating SARS-CoV-2 variants of concern and/or interest. Such the Linea 1.0 Assay’s unique double S-gene target design, is able to identify samples with a mutation profile indicative of BA.2 via SGTF.

“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.

BA.2 has been found in approximately 50 nations, including the United States, the United Kingdom, Israel, and Denmark, where it accounts for about half of all Omicron cases.  “preliminary calculations suggest BA.2 could be 1.5 times more infectious than BA.1.” according to Denmark’s Statens Serum Institute, the country’s primary infectious disease authority. The New York State Health Department, which is home to the majority of ADCL’s COVID-19 testing clients, confirmed the first instances of BA.2 on January 27, 2022. At least 20 States have sequenced the subvariant.

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