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Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA
Pathology Lab

Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer


The PATHWAY HER2 (4B5) test helps identify patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.

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TIME's Best Inventions of 2024
Innovations for Patients
TIME's Best Inventions of 2024

Our HPV self-collection solution was recognized and our pTau217 assay* was also mentioned in the Medical Care category, among 200 overall Best Invention recipients. These medical innovations aim to make cervical-cancer screening and Alzheimer's diagnosis more accessible and effective.

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*The pTau217 assay is available for research use only, not for use in diagnostic procedures. A similar version of the assay is under development and received FDA Breakthrough Device Designation.

Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
Pathology Lab
Roche expands companion diagnostic portfolio with FDA approval of CLDN18 assay

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfill an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer.

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Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives U.S. FDA Emergency Use Authorization
Respiratory
Four-plex test for SARS-CoV-2, Influenza A/B and RSV receives FDA Emergency Use Authorization

Now, HCPs will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.

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