Biofire lights the way with Covid-19 test de novo


Diagnostics developers and the US FDA are starting to look beyond the pandemic. Yesterday the US regulator granted the first formal clearance – as opposed to emergency use authorisation – for a Covid-19 diagnostic. The Biofire Respiratory Panel 2.1, made by the Biomérieux subsidiary Biofire, won an EUA in May, but this has now been revoked in favour of a de novo clearance. Unlike tests covered by EUAs, the RP2.1 panel will be allowed to remain on sale after the current public health emergency is declared over. To get the de novo, Biomérieux had to submit additional data beyond that needed for an EUA, including those from a trial of more than 500 test samples and a variety of analytical studies. It is no coincidence that the product is a syndromic panel. These tests are expected to be more useful in a post-pandemic setting where Covid-19 is relatively rare, since they can identify which of a swathe of respiratory pathogens is causing a patient’s symptoms. Biofire’s de novo is the first, but it will not be the last – particularly since, like all de novos, it creates a new regulatory classification which can be followed by other test developers.

Pathogens identified by the Biofire Respiratory Panel 2.1
Viruses Bacteria
Adenovirus Bordetella parapertussis
Coronaviruses 229E, HKU1, NL63 and OC43 (common cold) Bordetella pertussis
Middle East respiratory syndrome coronavirus (Mers) Chlamydia pneumoniae
Severe acute respiratory syndrome coronavirus 2 (Covid-19) Mycoplasma pneumoniae
Human metapneumovirus  
Human rhinovirus/enterovirus  
Influenza A, including subtypes H1, H3 and H1-2009, and influenza B  
Parainfluenza virus 1, 2, 3 and 4  
Respiratory syncytial virus  
Source: product instructions for use.

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