Therapy Areas: Respiratory
Roche wins FDA clearance for customisable respiratory pathogen test
2 November 2026 -

Healthcare company Roche (SIX: RO, ROP) (OTCQX: RHHBY) announced on Monday that it has received US Food and Drug Administration 510(k) clearance for its cobas eplex respiratory pathogen panel 3 (RP3), enabling laboratories to customise respiratory testing according to local disease prevalence and patient needs.

This test simultaneously detects up to 19 viral and bacterial targets from a single nasopharyngeal swab, including newly added Bordetella pertussis. Updated assays improve coverage of influenza A and SARS-CoV-2 strains. Laboratories can select from up to five panel configurations using cobas eplex system software version 3.0 or higher.

According to Roche, the automated sample-to-answer workflow requires less than one minute of hands-on preparation and delivers qualitative results in under two hours. Roche said the system is designed to support timely patient management, antibiotic stewardship and operational efficiency, particularly during peak respiratory seasons and for high-risk patients.

The clearance expands Roche's respiratory diagnostics portfolio, which includes singleplex and multiplex tests for viral and bacterial infections.

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