Roche secures FDA clearance for cobas eplex respiratory panel
The FDA has cleared Roche’s cobas eplex RP3, a rapid test that detects up to 19 viral and bacterial respiratory pathogens from one nasopharyngeal swab.
Roche has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the cobas eplexrespiratory pathogen panel 3 (RP3), a flexible, rapid syndromic test that identifies the causes of respiratory infections.
Key features:
Simultaneously detects up to 19 viral and bacterial targets, with broad strain inclusivity
Uses a single nasopharyngeal swab sample
Can detect influenza A virus, RSV and SARS-CoV-2, with the addition of Bordetella pertussis
Includes current influenza and SARS-CoV-2 strains
Automated "sample-to-answer" workflow process
Enables laboratories to tailor testing strategies with up to five distinct panel configurations
