14th February 2023 Product update: rapidmicrobiology staff writer
FDA Clearance and CLIA-waiver for Fast and Innovative BIOFIRE® SPOTFIRE® POC System
With the totally new and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel, bioMérieux further expands its syndromic testing technology outside traditional clinical laboratories to near patient testing locations such as urgent care in or outside of the hospitals, physician offices including paediatricians, and other healthcare facilities directly in contact with patients.
The BIOFIRE® SPOTFIRE® solution allows care for patients suspected of respiratory tract infections with results delivered during a patient’s visit in approximately 15 minutes. CLIA-waiver allows the BIOFIRE® SPOTFIRE® System and the BIOFIRE® SPOTFIRE® R Panel to be used by non-lab professionals at the point-of-care.
The BIOFIRE® SPOTFIRE® R Panel detects 15 of the most common bacteria, viruses, and viral subtypes that cause respiratory tract infections*.
To fully address the needs of Point of Care testing, bioMérieux has also developed the BIOFIRE® SPOTFIRE® R Panel Mini. This Panel is intended to detect 5 of the most common viral causes of upper respiratory tract infections: SARS-CoV-2 , Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus. The BIOFIRE® SPOTFIRE® R Panel Mini is not yet available for sale.The FDA submission of this panel is anticipated by the end of Q1 2023.
With a system footprint approximately the size of a standard sheet of paper and a scalability up to 4 modules, the system is designed to meet testing volume needs of any size of out of hospital setting.
The full commercial launch of BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® R Panel is scheduled for early April in the US market.
Additional BIOFIRE® SPOTFIRE® panels will be developed to meet other infectious disease patient needs at the point-of-care.
BIOFIRE® SPOTFIRE® R Panel detects:
* Viruses: Adenovirus, Coronavirus (seasonal), Coronavirus SARS-CoV-2, Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B virus, Parainfluenza virus, Respiratory syncytial virus.
Bacteria: Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae
BIOFIRE® SPOTFIRE® R Panel Mini detects:
SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.
Date Published: 14th February 2023
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.