29th March 2021  Product update: rapidvirology staff writer

Respiratory Panel that Detects 21 Pathogens + SARS-CoV-2 Secures FDA De Novo Status


bioMérieux has announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has received US FDA De Novo authorization for the BIOFIRE® RP2.1 Panel.

This panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2. The panel is the first SARS-CoV-2 diagnostic test of any kind that has been granted De Novo status by the US FDA, having gone through the normal US FDA review pathway outside of the Emergency Use Authorization (EUA) track.

This De Novo authorization will be concurrent with the revocation of the US FDA EUA that was obtained on May 1st, 2020, for this panel. The BIOFIRE® RP2.1 Panel EUA and De Novo kits are identical, with the exception of changes to the labeling.

The De Novo application was supported by a multicenter prospective clinical study in which the performance of the BIOFIRE® RP2.1 Panel SARS-CoV-2 assay was evaluated in over 500 specimens against a combined reference of three independent molecular SARS-CoV-2 assays, each with U.S. FDA EUA designation. The BIOFIRE® RP2.1 Panel SARS-CoV-2 assay demonstrated a positive percent agreement (PPA) of 98.4% and a negative percent agreement (NPA) of 98.9%.

The BIOFIRE® RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE® RP2.1 Panel yields result in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® Torch Systems with only 2 minutes of sample preparation time.

For more details, and to enquire about the availability of this product, please use the 'Request Information' button provided below. 


    

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Date Published: 29th March 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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