BioCode CoV-2 Flu Plus Assay uses nasopharyngeal swab specimens and runs on a high-throughput BioCode MDx-3000 molecular system
Applied BioCode gets FDA EUA for BioCode CoV-2 Flu Plus Assay. (Credit: Michal Jarmoluk from Pixabay.)
Applied BioCode has secured the US FDA’s emergency use authorisation (EUA) for its BioCode CoV-2 Flu Plus Assay to identify and distinguish between SARS-CoV-2, Influenza A with subtypes, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens.
The PCR-based molecular diagnostic assay can determine Influenza A, including seasonal H1, 2009 H1N1, H3, Influenza B subtypes.
BioCode CoV-2 Flu Plus Assay uses nasopharyngeal swab specimens and runs on the automated high-throughput BioCode MDx-3000 Molecular System.
The test facilitates the evaluation of patients with clinical signs and symptoms of respiratory infection. It provides a scalable throughput of up to 564 sample results per day.
Applied BioCode president Winston Ho said: “We have taken an important next step in strengthening our infectious disease menu by upgrading the BioCode SARS-CoV-2 Test to a Panel that now also includes influenza A, influenza B and RSV.
“Amid this pandemic, distinguishing one respiratory illness from another has never been so important for patients to reduce their anxiety.
“Our BioCode CoV-2 Flu Plus Assay will not only increase laboratory and hospital efficiency, but will also help physicians to make a more informed decision. We are very pleased to continue providing critical diagnostic testing solutions for the Covid-19 pandemic.”
The current EUA from FDA marks the third authorisation for Applied BioCode for its Covid-19 testing products.
The company has previously received FDA authorisation for its BioCode SARS CoV-2 Assay and sample pooling feature for the same assay.
Applied BioCode has developed its BioCode CoV-2 Flu Plus Assay based on its existing portfolio of high-throughput syndromic assays.
The syndromic assays include the FDA approved BioCode Respiratory Pathogen Panel, with 17 targets, BioCode Gastrointestinal Pathogen Panel with 17 targets.
Applied BioCode is an IVD manufacturer, focused on research, development, manufacturing, and marketing of testing kits and instruments for in vitro diagnostics.
The company has developed a bio-inspired Barcoded Magnetic Beads (BMB) technology, by combining digital barcodes with immuno- and molecular chemistry probes.