CE-IVD, US-IVD
The first FDA-approved companion diagnostic test for expanded EGFR tyrosine kinase inhibitors (TKI) therapies in patients with non-small cell lung cancer
The cobas® EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene, including the T790M resistance mutation.1
The cobas® EGFR Mutation Test v2 has been clinically validated in multiple clinical trials as a companion diagnostic (CDx) for both 1st and 2nd line EGFR tyrosine kinase inhibitors (TKI) therapy in patients with advanced non-small cell lung cancer [NSCLC).2 The exceptional robustness and repeatability of the cobas® EGFR Mutation Test v2 has been demonstrated in real-world intra and inter-laboratory studies,3 providing high confidence for labs in using the test.
It is designed to enable fast time-to-results testing of both tissue and plasma specimens simultaneously with a single kit (tissue results < 8 hrs, plasma results < 4 hrs).
For optimized workflow results, Roche has developed the cobas® DNA Sample Preparation Kit for DNA extraction from formalin-fixed paraffin-embedded tissue (FFPET) and the cobas® cfDNA Sample Preparation Kit for extraction of DNA from plasma.
Two sample types. One test.
The cobas® EGFR Mutation Test v2 not only provides clinicians with the option of using either tissue or plasma as biopsy samples, but it also makes the processing of these samples more convenient and efficient. When using the test in conjunction with the cobas® 4800 System, laboratory professionals can mix-batch each run with both sample types, as well as samples from different patients for up to 28 samples per run.
The overall workflow is similar regardless of sample type. After sample preparation, the amplification and detection of both sample types can be run together - giving labs the flexibility to deliver accurate results using both plasma and tissue samples.
Patients with advanced NSCLC may not be healthy enough for a tissue biopsy, or might only be able to undergo limited tissue procedures like a Fine Needle Aspirate (FNA) or Core Needle Biopsy (CNB) for diagnosis.
After first line TKI therapy, it is preferable to use a new tumour specimen for EGFR analysis, though this would require another invasive tissue biopsy procedure. A key benefit of testing with plasma is that it involves a non-invasive procedure for collecting a biopsy from the patient, which can be sampled as frequently as needed without putting the patient at risk.
For blood collection of the liquid biopsy, the cobas® EGFR Mutation Test v2 (CE-IVD) is approved for use with both the Roche Cell-Free DNA Collection Tube (CE-IVD) and K2EDTA tube, offering an alternative method for sample collection. The Roche Cell-Free DNA Collection Tube provides stability of collected blood for up to 7 days at room temperature prior to plasma separation. This increased flexibility in storage and transport of blood prior to plasma separation, facilitates the use of liquid biopsy for NSCLC patients needing molecular testing.
When testing plasma with the cobas® EGFR Mutation Test v2, a feature called the Semi-Quantitative Index (SQI)* is included in the report. This number is designed to reflect a trend in the EGFR mutation load. If frequently testing a patient for the EGFR mutation, tracking the SQI value and identifying a trend may lead to understanding tumour progression - an option not available in other tests.
*SQI Reporting Tool not available in the USA
CE-IVD, US-IVD
Access package inserts through your country’s Roche Diagnostics Website.
References