FDA Clears Roche's 19-Target Respiratory Panel

The cobas eplex respiratory pathogen panel 3 now has FDA 510(k) clearance for detecting up to 19 viral and bacterial targets from a single swab.

Updated on Nov. 2, 2026 in COVID-19

Bold flat-color editorial illustration of a sealed swab tube resting in an empty tray on a clean laboratory bench, evoking a single-swab multi-pathogen respiratory test. — The FDA cleared Roche's cobas eplex respiratory pathogen panel 3 on November 2, 2026, allowing U.S. labs to detect up to 19 viral and bacterial targets from one swab. AI Illustration. Upload story photo >

The FDA granted 510(k) clearance to Roche's cobas eplex respiratory pathogen panel 3 (RP3), a test that detects up to 19 viral and bacterial targets from one nasopharyngeal swab. Roche announced the clearance on November 2, 2026.

Why it matters

Clearance allows laboratories across the United States to run a broader multi-pathogen respiratory test on one specimen rather than several separate assays. The RP3 panel adds Bordetella pertussis and updated influenza and SARS-CoV-2 assays to the platform.

The RP3 test detects up to 19 viral and bacterial targets from one swab and returns qualitative results in under two hours, requiring less than one minute of hands-on preparation. Its customization feature requires cobas eplex software version 3.0 or higher, and detailed performance metrics were not included in the source data.

The players

Roche

Roche is a Swiss multinational healthcare and diagnostics company that manufactures the cobas eplex molecular testing system.

U.S. Food and Drug Administration

The FDA is the federal agency responsible for regulating medical devices, including granting 510(k) premarket clearance to diagnostic tests.

The details

Laboratories can choose from as many as five panel configurations based on local disease prevalence and patient needs. The earlier RP2 panel remains under Emergency Use Authorization and has not been FDA-cleared or approved.

November 2, 2026: Roche announces FDA 510(k) clearance of the RP3 panel.

Regulatory Path

The RP3 panel was cleared through the FDA's 510(k) pathway, which requires a device to be substantially equivalent to a legally marketed predicate, while its predecessor RP2 still operates under Emergency Use Authorization. That contrast marks the move from emergency-period testing toward standard regulatory clearance for multi-pathogen respiratory assays.

Patients may see a single nasopharyngeal swab used to screen for multiple respiratory pathogens, including influenza, SARS-CoV-2, and Bordetella pertussis, with results in under two hours. Availability will depend on individual laboratories adopting the panel and their chosen configuration.

The takeaway

Faster multi-pathogen testing can help clinicians identify the cause of respiratory illness from one specimen. Ask your provider whether a comprehensive respiratory panel is appropriate if you have symptoms.