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Applied BioCode Multiplex SARS-CoV-2/Flu/RSV Test Nabs EUA From FDA

NEW YORK – Applied BioCode announced on Thursday that its BioCode CoV-2 Flu Plus Assay, which detects SARS-CoV-2, influenza A/B, and respiratory syncytial virus, has received Emergency Use Authorization from the US Food and Drug Administration.

The PCR-based test can detect and differentiate between the respiratory diseases as well as between influenza A subtypes, such as seasonal H1, 2009 H1N1, and H3, the company said in a statement. It is designed for use with nasopharyngeal swab specimens and runs on the firm's BioCode MDx-3000 Molecular System, which allows for up to 564 results per day, Applied BioCode added.

"Amid this pandemic, distinguishing one respiratory illness from another has never been so important for patients to reduce their anxiety," Applied BioCode President Winston Ho said in a statement. "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."

The Santa Fe Springs, California-based company previously received EUA for its BioCode SARS-CoV-2 Assay and for pooling up to five samples with that test. Applied BioCode also has a 510(k)-cleared respiratory pathogen panel with 17 targets and a 510(k)-cleared gastrointestinal pathogen panel with 17 targets.