Applied BioCode has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BioCode CoV-2 Flu Plus Assay.
This PCR-based, multiplex molecular diagnostic assay can simultaneously detect and differentiate between SARS-CoV-2, Influenza A with subtypes (seasonal H1, 2009 H1N1, H3, Influenza B), and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens. The test is designed to assist physicians in evaluating patients with clinical signs and symptoms respiratory infection.
The BioCode CoV-2 Flu Plus Assay is Applied BioCode’s third EUA authorization from the FDA for COVID-19 testing. Applied BioCode previously received FDA EUA authorization for the BioCode SARS CoV-2 Assay and for pooling of up to five samples for that assay.
The BioCode CoV-2 Flu Plus Assay is run on the automated high-throughput BioCode MDx-3000 Molecular System and provides scalable throughput, allowing clinical labs to run up to 564 sample results per day.
“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,” says Winston Ho, PhD, Applied BioCode’s president. “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.”
BioCode CoV-2 Flu Plus Assay builds on the existing portfolio of high-throughput syndromic assays from Applied BioCode including the FDA 510(k) cleared BioCode Respiratory Pathogen Panel (17 targets), FDA 510(k) cleared BioCode Gastrointestinal Pathogen Panel (17 targets), and its stand-alone EUA authorized BioCode SARS-CoV-2 Assay.