Roche Holding stock: FDA clears customizable respiratory test
Published on 11/02/2026 at 18:27 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSDiagnostics clearance broadens Roche's pipeline
- The FDA cleared Roche's cobas eplex RP3 respiratory panel for US marketing.
- The test can detect up to 19 viral and bacterial targets from one sample.
- Roche's 2026 outlook remains focused on mid-single-digit sales growth and high-single-digit core EPS growth at constant exchange rates.
Roche secured a new regulatory milestone on Monday, November 2, 2026, as the US Food and Drug Administration cleared the cobas eplex respiratory pathogen panel 3. The 510(k) clearance gives Roche Diagnostics a new product for customizable respiratory testing in the United States, according to Morningstar, which carried Roche's press release.
New test targets respiratory infections
The cobas eplex RP3 panel can identify up to 19 viral and bacterial targets from a single nasopharyngeal sample. Roche added Bordetella pertussis detection and updated influenza A and SARS-CoV-2 assays to improve coverage of current and recently circulating strains.
Laboratories can choose from up to five panel configurations through the cobas eplex system software. The automated workflow requires less than one minute of hands-on preparation and returns qualitative results in under two hours, according to the company.
The clearance broadens Roche's respiratory diagnostics portfolio and gives laboratories more flexibility during periods of elevated seasonal demand. Commercial uptake will depend on laboratory adoption, reimbursement and the ability of the new panel to complement Roche's existing testing products.
Sales growth supports the outlook
Roche's latest operating update showed group sales of CHF 46.493 billion in the first nine months of 2026, with growth of 6 percent at constant exchange rates. The company maintained its outlook for mid-single-digit group sales growth and high-single-digit core earnings-per-share growth at constant exchange rates, while also expecting another dividend increase in Swiss francs.
Roche Holding stock traded at 431.43 euros on Lang & Schwarz at 18:21 CET on Monday, November 2, 2026. Investors can follow the real-time quote of Roche Holding stock.
Roche Holding AG at a glance
- Company: Roche Holding AG
- ISIN: CH1499059983
- Trading venue: Lang & Schwarz
- Price: 431.43 euros at 18:21 CET on November 2, 2026
- Regulatory milestone: FDA 510(k) clearance for the cobas eplex respiratory pathogen panel 3
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