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BioMérieux Point-of-Care System, Respiratory Panel Get FDA 510(k) Clearance, CLIA Waiver

This story has been updated from a previous version to include information from a BioMérieux statement.

NEW YORK ­– The US Food and Drug Administration said Tuesday that it has granted 510(k) clearance to the BioMérieux BioFire Spotfire System and Spotfire Respiratory (Spotfire R) Panel, an in vitro diagnostic used to simultaneously detect and identify multiple respiratory viral and bacterial infections in individuals suspected of having COVID-19 or other respiratory tract infections.

The platform and test were reviewed through the FDA's dual 510(k) and CLIA waiver pathway, making it the first COVID-19 test to be cleared with a CLIA waiver. In general, this means that the test can be used by operators in CLIA-waived settings and with limited or no training or hands-on experience in conducting laboratory testing — sometimes referred to as "untrained operators" — according to an FDA guidance document on the dual pathway.

BioMérieux introduced the Spotfire platform last summer with little fanfare. In a presentation accompanying its first-half 2022 results, it called Spotfire "a new modular system for molecular syndromic testing addressing point-of-care settings" and said the platform could provide results in less than 20 minutes with random-access testing of up to four tests simultaneously. It also said at the time that it had submitted the respiratory panel for FDA clearance.

In a statement, BioMérieux said the platform has a physical footprint about that of a standard sheet of paper and can be scaled up to four total modules to meet various testing volume needs.

"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," Pierre Boulud, chief operating officer, clinical operations at BioMérieux, said in a statement. "Our syndromic offer[ing] will cover most patient care settings in the US, expanding our business coverage and opportunities dramatically."

According to BioMérieux's website, the Spotfire R Panel uses a nasopharyngeal swab sample to detect as many as 15 targets including SARS-CoV-2, the cause of COVID-19. Other viral targets include influenza A and B virus, parainfluenza virus, respiratory syncytial virus (RSV), human rhinovirus, human metapneumovirus, seasonal coronavirus, and adenovirus. Bacterial targets include Bordetella pertussis, B. parapertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. The panel's full commercial launch in the US is expected in April.

BioMérieux also said that it has developed a pared-down version of the Spotfire R Panel called the Spotfire R Panel Mini, which is intended to detect five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, influenzas A and B, RSV, and rhinovirus. This assay is not yet for sale, and the company anticipates submitting it for FDA clearance by the end of the current quarter.