Predicts response to tyrosine kinase inhibitor (TKI) therapy.
Polymerase Chain Reaction/Pyrosequencing
DNA isolation: Sun-Sat
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.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely
Refer to report.
Laboratory Developed Test (LDT)
This test detects mutations in EGFR exons 18, 19, 20 and 21 (codons 719, 745-753, 768, 790, 858, and 861).
|Component Test Code*||Component Chart Name||LOINC|
|2002442||EGFR by Pyrosequencing||21665-5|
- EGFR-tyrosine kinase inhibitor
- Epidermal growth factor receptor
- Erlotinib Responsiveness in NSCLC
- Gefitinib Responsiveness in NSCLC
- IRESSA Responsiveness in NSCLC
- Non-small Cell Lung Cancer (NSCLC) Therapeutic Panel
- Tarceva Responsiveness in NSCLC