EGFR GENE MUTATION ANALYSIS

LAB1835

LAB1835
LabCorp TC: 489067
LabCorp Test Name: EGFR (Epidermal Growth Factor Receptor) Mutation Test v2, IVD
 

4 mL Lavender (EDTA) plasma - 2 tubes required

2mL Lavender (EDTA) plasma

Formalin-fixed, paraffin-embedded tissue block, or four unstained slides and one matching H&E-stained slide at 5uM

Spin and separate plasma after collection. Freeze plasma ASAP.

Frozen: Plasma
Room Temperature: Blocks/slides

Frozen: Plasma
Room Temperature: Blocks/slides

Frozen: 12 months
Room Temperature: 60 days

Hemolyzed blood, plasma not frozen, leaking or broken tubes
No tumor tissue present in the provided specimen; samples in which tumor cellularity is <10% after macrodissection

Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect at least 5% of mutant (with the exception of the 2240_2257del18 in exon 19, which is detected at >10%) in a background of wild-type genomic DNA. The cobas EGFR test can detect mutations in EGFR exons 18, 19, 20, and 21 with <= 100 copies of mutant DNA per mL of plasma using the standard input of 25uL of DNA per reaction well.

The FDA approved cobas EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations in exons 18, 19, 20, and 21 of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from FFPF tumor tissue or circulating-free tumor DNA (cDNA) from plasma derived from EDTA anticoagulated peripheral whole blood.