Applied BioCode Obtains Emergency Use Authorization for CoV-2 Flu Plus Assay


Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US 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 US 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 5 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,” said Applied BioCode’s President Winston Ho, Ph.D. “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.