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EGFR Mutation Detection by Pyrosequencing
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Ordering Recommendation
Predicts response to tyrosine kinase inhibitor (TKI) therapy.
Mnemonic
Methodology
Polymerase Chain Reaction/Pyrosequencing
Performed
DNA isolation: Sun-Sat
Assay: Varies
Reported
6-14 days
New York DOH Approval Status
Specimen Required
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
Tumor tissue. Also acceptable: DNA extracted by CLIA certified lab with corresponding client-circled H&E slide.
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.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Extracted DNA: Refrigerated.
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.
Include surgical pathology report.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely
Reference Interval
Interpretive Data
Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
Note
This test detects mutations in EGFR exons 18, 19, 20 and 21 (codons 719, 745-753, 768, 790, 858, and 861).
Hotline History
CPT Codes
88381; 81235
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2002148 | Block ID | 57723-9 |
| 2002442 | EGFR by Pyrosequencing | 21665-5 |
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
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