2002440
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EGFR Mutation Detection by Pyrosequencing

EGFR PCR
Example Reports
Not Detected
Positive

Ordering Recommendation

Predicts response to tyrosine kinase inhibitor (TKI) therapy.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Tumor tissue.

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)
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.

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Unacceptable Conditions

Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens.

Remarks

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.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Methodology

Polymerase Chain Reaction/Pyrosequencing

Performed

Varies

Reported

6-14 days

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.

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
05/15/2023
X
11/14/2022
X
X
N/A

CPT Codes

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