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December 17, 2021updated 07 Jan 2022 8:46am

FDA grants EUA for Applied BioCode’s CoV-2 Flu Plus Assay

The assay runs on BioCode MDx-3000 Molecular System, which allows clinical labs to provide up to 564 results a day.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Applied BioCode’s CoV-2 Flu Plus Assay.

The new multiplex molecular diagnostic BioCode CoV-2 Flu Plus Assay is designed to detect and differentiate between SARS-CoV-2, respiratory syncytial virus (RSV), as well as influenza A subtypes such as seasonal H1, 2009 H1N1, H3, Influenza B simultaneously.

It is intended to aid physicians to evaluate the clinical signs and symptoms of patients with a respiratory infection.

The PCR-based test uses nasopharyngeal swab specimens to detect SARS-CoV-2, influenza A, influenza B and RSV.

The assay runs on the company’s BioCode MDx-3000 Molecular System, which allows clinical laboratories to provide up to 564 results a day.

It represents Applied BioCode’s third EUA authorisation for Covid-19 testing from the FDA.

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Previously, the company’s BioCode SARS CoV-2 Assay received EUA and for pooling up to five samples for the same test.

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.

“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 new diagnostic assay builds on the company’s existing portfolio of syndromic assays that include its stand-alone EUA authorized BioCode SARS-CoV-2 Assay, FDA 510(k) cleared BioCode Gastrointestinal Pathogen Panel, and FDA 510(k) cleared BioCode Respiratory Pathogen Panel.

In November, Meridian Bioscience secured EUA from the US FDA for its Revogene SARS-CoV-2 assay.


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