Media Release

Laval, Quebec, 03.03.2017

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

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

Roche Diagnostics Canada announced that Health Canada has approved the cobas® EGFR Mutation Test v2, the first oncology assay from Roche that utilizes either plasma or tumor tissue as a sample. The test identifies 42 mutations in the epidermal growth factor receptor (EGFR) gene, the most of any In-vitro Diagnostic (IVD) on the market, and can also be used as an aid in selecting eligible patients with non-small cell lung cancer (NSCLC) for therapy with an EGFR tyrosine kinase inhibitor (TKI).

The next-generation test from Roche includes expanded mutation coverage of the epidermal growth factor receptor (EGFR) gene in DNA derived from tumor tissue and liquid biopsy. The test can be used to select for targeted treatment eligible non-small cell lung cancer (NSCLC) patients who harbor a T790M mutation, or eligible NSCLC patients with exon 19 deletions or L858R mutations.

“This Health Canada approval for a Companion Diagnostic designation for the cobas® EGFR Mutation Test v2 for liquid biopsy will help physicians identify lung cancer patients who are eligible for targeted therapies, thus expanding their therapy options said Ian Parfrement, President and General Manager, Roche Diagnostics Canada. Liquid biopsy has the potential to transform cancer patients testing and management.” 

According to a recent survey of more than 550 oncologists, EGFR genetic testing is not being conducted in about 25 percent of patients with NSCLC1,2. Some of the reasons for not testing included lack of diagnostic material and cases where a patient was deemed unfit to undergo biopsy. With the cobas® EGFR Mutation Test v2 being validated with both tissue and plasma sample types, patients who previously did not qualify for biopsy now have the opportunity to receive a result from a simple plasma test to guide the corresponding therapy.

About the cobas® EGFR Mutation Test v2

The cobas® EGFR Mutation Test v2 is a real-time PCR test that identifies 42 mutations in exons 18-21, including L858R, exon 19 deletions, L861Q and the TKI-resistance mutation, T790M. It is designed to enable testing of either tissue or plasma specimens with one kit, and allows labs to mix-batch tissue and plasma on the same plate. Additionally, Roche has developed a cell-free DNA (cfDNA) sample preparation kit that is optimized for extracting the DNA from plasma.

The cobas® EGFR Mutation Test v2 is designed to run on the cobas® 4800 System, v2.1 or higher. The system can also be used for the detection of mutations in the KRAS and BRAF gene of tumor samples.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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Roche Diagnostics Canada
Tel: (450) 686-3138


1. 2015 European Lung Cancer Conference (ELCC): Abstract LBA2_PR. Presented April 17, 2015

2. Davenport, Liam, "EGFR Testing Not Done in 25% of Lung Cancer Patients." Medscape Medical News, April 17, 2015