NEW YORK – BioMérieux announced on Tuesday that its BioFire SpotFire Respiratory Panel Mini has obtained CLIA wavier from the US Food and Drug Administration.
The SpotFire R Panel Mini detects SARS-CoV-2, influenza A and B, respiratory syncytial virus, and rhinovirus, the five most common viral causes of upper respiratory infections.
The sample-to-answer SpotFire test system is the first FDA-cleared PCR system to provide results in under 20 minutes, BioMérieux said in a statement. It can run both a large multiplex respiratory test of approximately 12 to 25 pathogens and a small multiplex respiratory test for three to five pathogens.
The system and associated panels are intended to expand BioMérieux's presence in the US outpatient market, the firm said.
BioMérieux obtained clearance and CLIA waiver from the FDA for the system and a 15-target assay called the BioFire SpotFire Respiratory Panel in February, and obtained 510(k) clearance for the mini panel in April.
The rhinovirus target in the mini panel is intended to increase the diagnostic yield of the assay.
"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" that are available in the US and only contain the other viruses, Mark Miller, executive VP and chief medical officer at BioMérieux, said in a statement.
CLIA waiver now allows the system and its two existing respiratory panels to be used by non-lab professionals at the point of care.
"CLIA waiver for BioFire SpotFire facilitates use in any clinical setting where patients seek care; be it an urgent care, physician office, local pharmacy, student health clinic, or emergency department," Jennifer Zinn, general manager and head of clinical operations for North America at BioMérieux, said in a statement.
With a 15-minute time to result, the system "has the potential to improve clinical decisions, optimize clinical operations, and most importantly, support antimicrobial stewardship at the individual provider level," Zinn also said.