The cobas® EGFR Mutation Test v2 is performed in a molecular laboratory.
The test is performed on DNA derived from circulating cell-free DNA in human plasma samples.
Two mLs of K2 EDTA plasma are required to perform the test. One 6 mL K2 EDTA collection tube will provide enough plasma for one test, additional tubes may be required by the lab to ensure enough sample is available for repeat testing if required. Plasma must be separated from whole blood within 4 hours of collection following the collection tube instructions.
*Plasma can be transported and stored at <-70°C for up to 12 months or at 2-8°C for up to 3 days before testing is performed.
The cobas® EGFR Mutation Test is performed in a molecular laboratory.
The test is performed on DNA derived from formalin-fixed, paraffin embedded (FFPET) human non-small cell lung cancer (NSCLC) tumor tissue.
Two 5 µm sections from the FFPE block are required to perform the test. The test can be performed on either primary or metastatic lesions.
One 5 µm section is subjected to Hematoxylin and Eosin (H&E) staining to determine if the tissue section contains sufficient tumor content to run the test.
The second section will be utilized for the PCR test. DNA will be isolated from this tissue section for the PCR reaction.
NSCLC FFPET specimens can be stored at 15-30°C for up to 12 months
Five µm sections mounted on slides may be stored at 15-30°C for up to 60 days