The COVID-19 pandemic has underscored the importance of ensuring that healthcare professionals have access to diagnostic tests in close proximity to patients, delivering prompt and actionable results. Now, an innovative syndromic testing technology has arrived from outside traditional clinical laboratories to near patient testing locations such as urgent care in or outside of the hospitals, physician offices including pediatricians, and other healthcare facilities directly in contact with patients.

bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® solution allows care for patients suspected of respiratory tract infections with results delivered during a patient’s visit in approximately 15 minutes. 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.

With a system footprint approximately the size of a standard sheet of paper and a scalability up to four modules, the system is designed to meet testing volume needs of any size of out of hospital setting. The BIOFIRE® SPOTFIRE® system offers the BIOFIRE® SPOTFIRE® R Panel that detects 15 of the most common bacteria, viruses, and viral subtypes that cause respiratory tract infections. It also offers the new BIOFIRE® SPOTFIRE® R Panel Mini that detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2 (virus associated with COVID-19), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus, in about 15 minutes.

bioMérieux has received US FDA 510(k) clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel. 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. In addition, bioMérieux has received US FDA 510(k) clearance for the fast and accurate multiplex PCR-based BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. The filing for CLIA-waiver of the BIOFIRE® SPOTFIRE® R Panel Mini will immediately follow FDA-clearance.

“Our new system is a true revolution in healthcare with an unprecedented time to result and proximity to the patient. It opens the door for bioMérieux to deliver the proven medical value associated with multiplex panels to many more individuals, in decentralized near-patient settings” said Mark Miller, Executive Vice President, Chief Medical Officer, bioMérieux.

“We are proud to deliver such an innovative syndromic testing technology at the Point of Care. We believe the BIOFIRE® SPOTFIRE® solution is a real game changer in patient care, allowing physicians to give patients an accurate and rapid diagnosis, using only one test, during the actual patient visit. Our syndromic offer will cover most patient care settings in the US -expanding our business coverage and opportunities dramatically,” declared Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux. 

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