FDA Clears Roche’s cobas eplex Respiratory Pathogen Panel 3

Roche Diagnostics announced Monday, Nov. 2, at 9:30 a.m. ET (2:30 p.m. UTC) that the U.S. Food and Drug Administration had granted 510(k) clearance to its cobas eplex respiratory pathogen panel 3 (RP3), an automated test for respiratory infections.

RP3 detects up to 19 viral and bacterial targets from one nasopharyngeal swab. Its panel includes Bordetella pertussis and updated assays for influenza and SARS-CoV-2.

Laboratories can select from as many as five panel configurations based on local disease prevalence and patient needs. The customization feature requires cobas eplex system software version 3.0 or higher. The test requires less than one minute of hands-on preparation and provides qualitative results in less than two hours.

The FDA’s 510(k) pathway is used for devices shown to be substantially equivalent to a legally marketed device. Roche’s earlier cobas eplex respiratory pathogen panel 2 is authorized under an Emergency Use Authorization and has not been FDA-cleared or approved.