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FDA Grants Roche Label Extension for the cobas® EGFR Mutation Test v2 for use with Plasma as a Companion Diagnostic for TAGRISSO™

Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas® EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s …

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FDA Grants First Liquid Biopsy Approval to the Roche cobas® EGFR Mutation Test v2

Test can be used with either plasma or tumor tissue, as a companion diagnostic for non-small cell lung cancer therapy.

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Roche receives approval in Japan for the cobas® EGFR Mutation Test v2 

New test includes expanded mutation coverage to detect EGFR mutations in non-small cell lung cancer patients.

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cobas® DNA Sample Preparation Kit

The cobas® DNA Sample Preparation Kit is used for manual sample preparation to process FFPET specimens and isolate…

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cobas® EGFR Mutation Test v2 (US-IVD)

The cobas® EGFR Mutation Test v2 (US-IVD), identifies mutations in the epidermal growth factor receptor (EGFR) gene in in tumor tissue DNA from non-small cell lung cancer (NSCLC)…

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cobas® EGFR Mutation Test v2-RUO

The cobas® EGFR Mutation Test v2, for research use only (RUO), identifies the epidermal growth factor receptor (EGFR) gene…

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cobas® EGFR Mutation Test v2 (CE-IVD)

The cobas® EGFR Mutation Test v2 CE-IVD, identifies the epidermal growth factor receptor (EGFR) gene in the DNA from…

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Roche receives FDA approval for cobas® EGFR Mutation Test v2 as a companion diagnostic for non-small cell lung cancer therapies

Next-generation test using tissue samples is approved for use as a companion diagnostic with AstraZeneca’s new therapy, TAGRISSO™

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Roche launches the cobas® EGFR Mutation Test v2 for use with either plasma or tumour tissue samples

New test is the first to be validated for use of either sample type in a single test.

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Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy

The cobas® EGFR Mutation Test v2 is designed for expanded EGFR mutation detection in non-small cell…

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FDA approves Tarceva (erlotinib) tablets and cobas EGFR Mutation Test for specific type of lung cancer

Tarceva is the first personalised medicine approved for the initial treatment of people with EGFR mutation-positive metastatic non-small cell lung cancer in the United States.

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Roche obtains license for EGFR lung cancer assays and will develop Tarceva companion diagnostic test

Molecular assay aims to enhance personalized treatment with Tarceva by detecting EGFR activating mutations

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Roche Signs Exclusive Distribution Deal with DxS for K-RAS and EGFR Cancer Mutation Tests

Tests identify genetic mutations that can affect patient response to certain cancer drugs.

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