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Regulatory approval for bioMérieux’s BIOFIRE SPOTFIRE R/ST panel

In vitro diagnostics firm bioMérieux has announced that its BIOFIRE SPOTFIRE respiratory/sore throat (R/ST) panel has received both 510(k) clearance from the US FDA and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.

The BIOFIRE SPOTFIRE R/ST panel is a unique multiplex PCR test capable of detecting and identifying nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected, or from a throat swab in cases of a pharyngitis syndrome.

“To prescribe or not to prescribe antimicrobials is the age-old question for outpatient upper respiratory infections. The flexibility of this syndromic panel allows healthcare professionals to test for multiple pathogens with overlapping signs and symptoms, ultimately allowing the diagnostic to drive informed decision-making during the outpatient visit. These results further empower the advancement of antimicrobial stewardship and modernise patient care.” declared Dr Charles K Cooper, Executive Vice-President, Chief Medical Officer, bioMérieux.

The COVID-19 pandemic has demonstrated the need for healthcare professionals to have diagnostic tests available as close as possible to the patient, providing actionable results quickly. A fast and innovative syndromic testing range, BIOFIRE SPOTFIRE perfectly matches these new medical needs worldwide.

The R/ST panel is the third panel to receive FDA clearance for use on the BIOFIRE SPOTFIRE system, following the Respiratory (R) Panel and Respiratory (R) Panel Mini, detecting 15 and 5 of the most common respiratory pathogens, respectively.

A CLIA-waiver allows the BIOFIRE SPOTFIRE System and its so-authorised panels to be used by non-laboratory professionals and in any clinical setting where patients seek care including an urgent care, physician office, local pharmacy, student health clinic, or an emergency department.

“Receiving FDA clearance for the BIOFIRE SPOTFIRE R/ST Panel, just one year afterthe successful launch of the BIOFIRE SPOTFIRE solution, marks another milestone in our mission to move testing closer to the patient,” said Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux. “With our innovative approach, we are committed to enhancing patient care by providing healthcare professionals with the tools they need to deliver expedited and effective diagnoses. Together, we are revolutionising the landscape of healthcare, one diagnosis at a time.”

The BIOFIRE SPOTFIRE R/ST Panel is currently CE-marked under IVDD (In Vitro Diagnostic Directive) and has been submitted for CE-marking under IVDR (In Vitro Diagnostic Regulation).

 

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Upcoming Events

Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

Sheffield Hallam University, City Campus, Howard Street, Sheffield
24th May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

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