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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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Non-small cell lung cancer (NSCLC)

Lung cancer is the leading malignant cause of death in 93 countries, accounting for a fifth of the total global burden of disability-adjusted life years from cancer.1

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Melanoma

One in three cancers diagnosed is a skin cancer, with 132,000 cases of melanoma occurring each year.1

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Colorectal cancer (CRC)

Colorectal cancer is one of the most common cancers in the world, with over 1.4 million new cases diagnosed each year. Obtaining an early diagnosis is critical as it is currently one of the deadliest cancers, totaling more than 600,000 deaths each year.1,2

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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® 4800 BRAF V600 Mutation Test

The cobas® 4800 BRAF V600 Mutation Test detects the BRAF V600E mutation in formalin-fixed, paraffin-embedded (FFPET)…

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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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cobas® KRAS Mutation Test

Detects all of the reported mutations in KRAS codons 12, 13 and 61 to assess likelihood of patient response…

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cobas® PIK3CA Mutation Test

The cobas® PIK3CA Mutation Test is a real-time PCR test for the…

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Factor II (Prothrombin) G20210A Kit

An in vitro diagnostic test that allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood.

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Factor V Leiden Kit

Detection and genotyping of a single point mutation of the human Factor V gene

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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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Roche Receives FDA Approval for cobas® KRAS Mutation Test

Molecular PCR test identifies KRAS mutations to aid in determining therapy for metastatic colorectal cancer

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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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Companion Diagnostic Test that Identifies Patients With Melanoma Tumor Mutation Available in Europe

cobas BRAF Mutation Test is used to identify patients with melanoma tumors that harbor a genetic...

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KRAS Diagnostic Test that assists with personalized treatment of colorectal cancer receives CE Mark

cobas KRAS Mutation Test identifies colorectal cancer patients not likely to respond to anti-EGFR antibody therapies

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Roche and Merck Collaborate to Develop Diagnostic Tests for Merck’s Investigational Cancer Therapies

Roche and Merck Collaborate to Develop Diagnostic Tests for Merck’s Investigational Cancer Therapies

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Roche and Clovis Oncology to co-develop EGFR companion diagnostic

Collaboration focused on personalized treatment of non-small-cell lung cancer

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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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Preliminary Data from Roche ATHENA Cervical Cancer Trial Support Value of Human Papillomavirus Genotyping

Preliminary Data from Roche ATHENA Cervical Cancer Trial Support Value of Human Papillomavirus Genotyping

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Roche Collaborates with Merck on Developmental Test for Cancer-Related Gene Mutation

Investigational AmpliChip p53 Test Designed to Screen for Genetic Mutation Tied to Therapeutic Resistance in Cancer Patients

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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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