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

6-14 days

New York DOH Approval Status
This test is New York DOH approved.
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 https://ltd.aruplab.com/tests/pdf/366

Collect

Tumor tissue. Also acceptable: DNA extracted by CLIA certified lab with corresponding client-circled H&E slide.

Specimen Preparation

Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Tissue block will be returned after testing. Transport tissue block or 5 unstained 5-micron slides. (Min: 3 slides)
Fine Needle Aspirate (FNA): 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.
Extracted DNA: Transport 40 uL DNA with at least 50 ng/uL concentration. (Min: 40 uL) Transport DNA 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.
Extracted DNA: Refrigerated.

Unacceptable Conditions

Less than 25 percent tumor. DNA extracted by a non-CLIA lab. DNA extracted without a corresponding circled H&E slide. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens. FNA smears with less than 50 tumor cells.

Remarks
Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely

Reference Interval
Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. 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 (codons 719, 745-753, 768, 790, 858, and 861).

Hotline History
N/A
CPT Codes

88381; 81235

Components
Component Test Code* Component Chart Name LOINC
2002148 Block ID 57723-9
2002442 EGFR by Pyrosequencing 21665-5
* 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
EGFR Mutation Detection by Pyrosequencing