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The cobas® EGFR Mutation Test v2 is a real-time PCR test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene, including the T790M resistant mutation.
It is designed to enable testing of both tissue and plasma specimens with a single kit, and allows labs to run tissue and plasma on the same plate simultaneously. For optimized workflow results, Roche has developed a cell-free DNA (cfDNA) sample preparation kit to optimize extraction of DNA from plasma.
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. Using the test in conjunction with the cobas® 4800 System, laboratory professionals can mix-batch each run with both sample types and even samples from different patients.
The overall workflow is the same regardless of sample type, with slightly different preparation steps. Formalin-fixed, paraffin-embedded tissue (FFPET) specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. After preparation, the amplification and detection of both sample types can be run together— giving labs the flexibility to deliver accurate results using both sample types.
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. The key benefits of testing with plasma is that it involves a non-invasive procedure for collecting biopsy from the patient and it can be sampled as frequently as needed without putting patients at risk.
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 tumor progression, an option not available in other tests.
*SQI feature is currently not available in the USA.
Many patients with advanced NSCLC are too unhealthy for an invasive tissue biopsy, while others will only be able to undergo limited tissue procedures to have a Fine Needle Aspirate (FNA) or Core Needle Biopsy (CNB) for diagnosis. Additionally, after first line TKI therapy, it’s preferable to use a new tumor specimen for EGFR analysis, yet this would require another invasive tissue biopsy procedure. The key benefits of testing with plasma is that it involves a non-invasive procedure for collecting biopsy from the patient and it can be sampled frequently without putting patients at risk.
For more information on testing for EGFR mutations in plasma and tissue samples from non-small cell lung cancer patients, explore the publications below.
CE-IVD, US-IVD, RUO
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