PCR testing cannot be added on to a sample that has been opened and/or used for other testing. If the sample has already been used for testing, a new specimen will need to be collected.
Please label each final plasma collection tube with the word "Plasma". Testing will be delayed if the tube is not labeled properly.
Blood Collection
• Blood should be collected according to your laboratory's procedure for venipuncture using three K2EDTA 4-mL blood collection tube.
Provide a copy of the pathology report or related ICD10 code on the requisition. EGFR test will be delayed if the pathology report and clinical indications are not received.
Plasma preparation should be performed within four hours of specimen collection.
Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp)
Blocks or slides
Ambient (preferred)
Stability of FFPE block specimens stored at 15 - 30ºC for 12 months after the date of collection has been confirmed.
Five-micron sections mounted on slides may be stored at 15 - 30ºC for 60 days.
Plasma
Frozen (strict) - 12 months
No tumor tissue present in the provided specimen; broken or stained slides; hemolyzed blood; plasma not frozen; plasma volume <2 mL per tube; leaking or broken tubes
An interpretive report will be provided
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 FFPE tumor tissue or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anticoagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the table below in accordance with the approved therapeutic product labeling:
Drug:
Tarceva® (erlotinib)
FFEP: Exon 19 deletions and L858R
Plasma: Exon 19 deletions and L858R
Tagrisso™ (osimertinib)
FFPE: Exon 19 deletions, T790M and L858R
Plasma: Exon 19 deletions, T790M* and L858R
IRESSA™ (gefitinib)
FFPE: Exon 19 deletions and L858R
Plasma: Exon 19 deletions and L858R
*The efficacy of Tagrisso™ (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.
Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutations Test v2:
Drug:
Tarceva® (erlotinib)
FFPE: G719X, S768I, T790M, exon 20 insertions and L861Q
Plasma: G719X, S768I, T790M, exon 20 insertions and L861Q
Tagrisso™ (osimertinib)
FFPE: G719X, S768I, exon 20 insertions and L861Q
Plasma: G719X, S768I, exon 20 insertions and L861Q
Iressa® (gefitinib)
FFPE: G719X, S768I, T790M, exon 20 insertions and L861Q
Plasma: G719X, S768I, T790M, exon 20 insertions and L861Q
Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medical billing request form along with the sample.