SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--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.
For more information on the BioCode® SARS-CoV-2 Assay, visit: https://apbiocode.com/sars-cov-2.htm
About Applied BioCode
Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products. The company has combined “digital barcodes” with immuno- and molecular chemistry to create a new, bio-inspired Barcoded Magnetic Beads (BMB) technology. The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets. The company has FDA 510K clearances for their Respiratory 17-plex Pathogen Panel (RPP) and Gastrointestinal 17-plex Pathogen Panel (GPP) based on their BioCode® MDx-3000 automated system. The GPP and RPP are CE-Marked for use in European countries conforming to CE-Mark regulations. Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*. Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.
*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner