Applied DNA Clinical Labs (ADCL), the clinical laboratory subsidiary of Applied DNA Sciences, has announced plans to deploy the Linea 1.0 COVID-19 Assay for rapid identification of mutations indicating the presence of the new BA.2 subvariant (BA.2) of Omicron.
The Linea 1.0 Assay is part of the company’s Linea Covid-19 diagnostics and testing portfolio.
Similar to a genomic surveillance solution, the new assay has clinical utility and helps public health authorities identify and assess the spread of BA.2 through reflex testing of positive Covid-19 samples.
Compared to expensive and time-consuming next-generation sequencing, Linea 1.0 Assay enables the rapid and cost-effective detection of BA.2 in positive samples as a reflex test.
Initially identified in November last year, BA.2 is the descendant of the Omicron variant (BA.1) but differs in some of its genetic traits, such as certain spike protein mutations.
The company stated that these mutations may make it difficult to detect BA.2 through S-gene target failure (SGTF) on certain third-party assays.
ADCL has conducted an in-silico analysis of the BA.2 subvariant and noted that the subvariant will result in a unique detection signature using the Linea 1.0 Assay.
This detection process is different from identifying the Omicron variant as well as other SARS-CoV-2 variants of concern and/or interest.
Due to the unique double S-gene target design, Linea 1.0 Assay can detect samples containing the mutation that indicates the BA.2 subvariant.
Applied DNA president and CEO Dr James Hayward said: “Deploying Linea 1.0 Assay towards BA.2 potentially positions ADCL for incremental testing demand while also offering clinical utility to epidemiologists presently analysing 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.”
Recently, ADCL submitted a request to the US Food and Drug Administration (FDA) seeking Emergency Use Authorisation (EUA) for the Linea 2.0 COVID-19 Assay and Linea Unsupervised At-Home Sample Collection Kit.