EGFR Mutation Detection by Pyrosequencing

2002440
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Example Reports
Not Detected
Positive
Ordering Recommendation

Predicts response to tyrosine kinase inhibitor (TKI) therapy.

Mnemonic
EGFR PCR
Methodology

Polymerase Chain Reaction/Pyrosequencing

Performed

DNA isolation: Sun-Sat
Assay: Varies

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

Include surgical pathology report.

Stability

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

Reference Interval
Interpretive Data

Refer to report.

Compliance Category

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

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
08/19/2019
X
X
02/19/2019
X
N/A
CPT Codes

88381; 81235

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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