bioMérieux's BIOFIRE SPOTFIRE R Panel Mini receives FDA CLIA-waiver

bioMérieux has received U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) waiver for the fast and accurate multiplex PCR-based BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. This decision comes in addition to the 510(k) clearance obtained last April.

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. The BIOFIRE SPOTFIRE R Panel Mini is the second multiplex PCR-based test cleared for use on the BIOFIRE SPOTFIRE System. Both this system and its 15-target BIOFIRE SPOTFIRE Respiratory Panel received FDA-clearance and CLIA-waiver in February 2023.

The new BIOFIRE SPOTFIRE R Panel Mini detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus, in about 15 minutes.

“We know that in the post-pandemic world patients justifiably demand diagnostic results which are important to them and their families. The inclusion of Rhinovirus into this syndromic panel increases clinicians’ ability to provide their patients with a definitive result compared to the other respiratory tests available in the United States which contain only the other 1-4 viruses” declared Mark Miller, Executive Vice-President, Chief Medical Officer, bioMérieux.

The BIOFIRE SPOTFIRE System is a small, scalable, multiplex PCR platform designed to bring central laboratory diagnostic results to the decentralized point-of-care (POC) clinical setting. It is the first FDA-cleared PCR system to provide results in under 20 minutes and can run both a large multiplex respiratory test in the 12-25 pathogen target range, and a small multiplex respiratory test in the 3-5 pathogen target range.

CLIA-waiver allows the BIOFIRE SPOTFIRE System and its two existing respiratory panels to be used by non-lab professionals at the point-of-care.

Want the latest science news straight to your inbox? Become a SelectScience member for free today>>