Roche Holding stock gets FDA clearance for flexible RP3 test

Published on 11/04/2026 at 11:51 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Roche Holding stock gets a new US diagnostics milestone after FDA clearance for its customizable RP3 respiratory panel. The test broadens the company's portfolio.

Roche expands respiratory diagnostics

The FDA cleared Roche's cobas eplex RP3 respiratory pathogen panel on November 2.
The panel detects up to 19 viral and bacterial targets and adds Bordetella pertussis detection.
Laboratories can select up to five configurations, with results available in less than two hours.

Roche Holding, CH1499059983, Illustration mit AI erstellt.

Roche announced on November 2, 2026, that the U.S. Food and Drug Administration had granted 510(k) clearance to its cobas eplex respiratory pathogen panel 3, or RP3. The company said the clearance expands its respiratory diagnostics portfolio and gives laboratories more flexibility in selecting tests for local patient needs.

Roche Holding stock traded at 424.25 euros on Lang & Schwarz at 11:40 CET on Wednesday, November 4, 2026. The quote is a market indication and is not presented with a daily percentage comparison because no dated Xetra closing basis was established.

Flexible testing targets local needs

The RP3 panel can simultaneously detect up to 19 viral and bacterial targets from a single nasopharyngeal swab sample. The panel covers pathogens including influenza A, respiratory syncytial virus and SARS-CoV-2, while adding Bordetella pertussis detection. Roche also said the influenza and SARS-CoV-2 assays were updated to improve coverage of current and recently circulating strains.

Laboratories can choose from up to five panel configurations based on local disease prevalence and patient populations. The feature requires 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 produces qualitative results in less than two hours, with 24/7 availability.

Roche Diagnostics North America President and CEO Dan Malarek said rapid respiratory results can support patient management and antibiotic stewardship. Roche's announcement also linked faster diagnosis with fewer additional tests and radiographs, less unnecessary antibiotic use and shorter discharge times. Those comments describe the intended clinical and operational benefits; they do not provide a sales forecast for RP3.

Regulatory clearance adds portfolio depth

The clearance differentiates RP3 from Roche's earlier cobas eplex respiratory pathogen panel 2, which the company says remains available under an Emergency Use Authorization and has not been cleared or approved by the FDA. The new authorization therefore adds a cleared product to Roche's respiratory testing offering while extending the installed cobas eplex platform.

For investors, the announcement provides a regulatory and product-development catalyst rather than a quantified earnings outlook. Roche disclosed no expected revenue, pricing or commercial rollout timetable in the announcement. Adoption by laboratories, the pace of deployment and the contribution of the panel to Diagnostics sales remain the next commercial markers.

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