Roche Holding stock gets FDA clearance for customizable RP3 test

Published on 11/04/2026 at 18:36 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Roche Holding stock gains a fresh diagnostics catalyst after US regulators cleared its customizable RP3 respiratory panel. The test broadens laboratory options.

Roche expands respiratory diagnostics

The FDA cleared Roche's cobas eplex RP3 panel on November 2.
The test adds Bordetella pertussis and updated influenza and SARS-CoV-2 coverage.
Flexible configurations could support laboratory demand during respiratory disease seasons.

Roche Holding, CH1499059983, Illustration mit AI erstellt.

Roche announced on November 2 that the US Food and Drug Administration had granted 510(k) clearance to its cobas eplex respiratory pathogen panel 3. The company said the test expands its respiratory diagnostics portfolio by combining broader pathogen coverage with configurable laboratory workflows.

The Roche release says RP3 can detect up to 19 viral and bacterial targets from a single nasopharyngeal swab. The panel adds Bordetella pertussis and updates influenza and SARS-CoV-2 assays to improve coverage of current and recently circulating strains.

What changes for Roche diagnostics

Laboratories can select up to five panel configurations through cobas eplex system software version 3.0 or higher. Roche says the automated sample-to-answer workflow requires less than one minute of hands-on preparation and produces qualitative results in under two hours.

For investors, the clearance strengthens Roche's diagnostics offering in infectious diseases, but the company did not provide sales expectations, pricing or a commercial rollout timetable in the release. Adoption will therefore depend on laboratory demand, purchasing decisions and the use of Roche's existing cobas eplex platform.

Roche Holding stock traded at 432.88 euros on Lang & Schwarz at 18:32 CET on Wednesday, November 4, 2026.

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