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EGFR Mutation Detection by Pyrosequencing
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Predicts response to tyrosine kinase inhibitor (TKI) therapy.
Polymerase Chain Reaction/Pyrosequencing
DNA isolation: Sun-Sat
Assay: Tue, Thu, Sat
6-14 days
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.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely
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.
This test detects mutations in EGFR exons 18, 19, 20 and 21 (codons 719, 745-753, 768, 790, 858, and 861).
Hotline History
88381; 81235
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2002148 | Block ID | 57723-9 |
| 2002442 | EGFR by Pyrosequencing | 21665-5 |
- 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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