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cobas® EGFR Mutation Test v2

Use plasma or tumor tissue samples to identify 42 mutations of the EGFR gene and inform confident treatment decisions.

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cobas® HCV Test

Inform therapy decisions with innovative, state-of-the-art, dual-probe HCV viral load testing for the cobas® 4800/6800/8800 Systems

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cobas® cfDNA Sample Preparation Kit

The cobas® cfDNA Sample Preparation Kit is used for manual sample preparation to isolate circulating cell-free DNA from plasma samples in combination with cobas® genomics and oncology assays, including the cobas® EGFR Mutation Test.

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COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0: Qualitative and Quantitative

Accurately detect HCV and confidently monitor viral load results.

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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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Human papillomavirus (HPV)

Recent research has identified the Human papillomavirus as the cause of 99 percent of all cervical cancer.

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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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Hepatitis C (HCV)

Approximately 130–150 million people globally have a chronic hepatitis C infection, with 3 to 4 million new infections occurring each year.1

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Hepatitis B (HBV)

An estimated 240 million people worldwide carry a chronic hepatitis B infection, and more than 780,000 die each year due to complications like cirrhosis and liver cancer.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®  HCV GT for use on the cobas®  4800 System

Test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in…

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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® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0

Avoid false positives and increase laboratory efficiency while ensuring confident clinical decisions.

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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® HBV for use on the cobas® 6800/8800 System

Get robust, clinically relevant assay performance for optimal results and a highly efficient laboratory workflow.

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cobas® HPV

Deliver 3 results in 1 test. Simultaneously detect 14 high-risk HPV types and obtain specific genotyping information for HPV 16 & 18.

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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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COBAS® TaqMan® HBV Test For Use With The High Pure System 

Hepatitis B virus (HBV) viral load quantification test used in the management of patients with chronic HBV…

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COBAS® TaqMan® HCV Test v2.0 For Use With The High Pure System

Utilizes real-time PCR technology for the detection and quantitation of HCV RNA genotypes 1-6 as an aid…

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LINEAR ARRAY® HPV Genotyping Test

Persistent HPV infection with specific high-risk HPV types is an indicator of high grade lesions (HSIL).1 HPV genotyping assays, may be used in cytology negative, HR-HPV-positive women over 30 in the same…

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cobas® HBV for use on the cobas® 4800 System

Perform HBV viral load testing with a robust and clinically relevant assay for optimal results and a highly efficient laboratory workflow.

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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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