EGFR Mutation Detection by Pyrosequencing
2002440
Ordering Recommendation
Predicts response to tyrosine kinase inhibitor (TKI) therapy.
Mnemonic
EGFR PCR
Methodology
Polymerase Chain Reaction/Pyrosequencing
Performed
DNA isolation: Sun-Sat
Assay:
Tue, Thu, Sat
Reported
10-12 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
For a general FNA collection and smear preparation refer to ARUP's Laboratory Test Directory: Cytology, Fine Needle Aspiration Collection at http://www.aruplab.com/guides/ug/tests/arup014.jsp  
Collect
Tumor tissue.  
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Transport tissue block or 5 unstained 5-micron slides. (Min: 3 slides) Tissue block will be returned after testing. A Fine Needle Aspirate (FNA) smear may also be submitted. Prepare FNA smear with Diff-Quik or equivalent stain by standard methods (air-dried slides are preferred). Number of slides needed is dependent on the tumor cellularity of the smear. (Min: 1 slide). Slide(s) will be destroyed during testing process and will not be returned to client.
Transport block and/or slide(s) in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.  
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.  
Unacceptable Conditions
Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Decalcified specimens. FNA smears with less than 50 tumor cells.  
Remarks
  
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
   
Interpretive Data
Refer to report.

See Compliance Statement B: www.aruplab.com/CS
Statement B: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
 
Note
This test detects mutations in EGFR exons 18, 19, 20 and 21.
CPT Code(s)
88381; 81235
Components
Component Test Code*Component Chart Name
2002148Block ID
2002442EGFR by Pyrosequencing
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • EGFR-TKI
  • EGFR-tyrosine kinase inhibitor
  • Epidermal growth factor receptor
  • ERBB1
  • Erlotinib Responsiveness in NSCLC
  • Gefitinib Responsiveness in NSCLC
  • IRESSA Responsiveness in NSCLC
  • Non-small Cell Lung Cancer (NSCLC) Therapeutic Panel
  • Tarceva Responsiveness in NSCLC