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HelpTest ID EGFRD EGFR Exon 18, 19, 20, 21, Mutation Analysis, Cell-Free DNA, Plasma
Advisory Information
This test is not a prenatal screening test. To evaluate for the presence of common fetal chromosome abnormalities using cell-free DNA, see NIPS / Cell-Free DNA Prenatal Screen.
For T790M mutation only testing, order T790M / Cell-Free DNA EGFR T790M Test, Blood.
Shipping Instructions
Send plasma frozen.
Specimen Required
Specimen Type: Plasma
Collection Container/Tube: Lavender top (K2 EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 10 mL
Collection Instructions: 1. Centrifuge within 4 hours of collection. 2. Aliquot plasma into plastic vial and freeze.Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
Useful For
As an alternative to invasive tissue biopsies for the determination of EGFR-mutation status
Selection of patients with non-small cell lung cancer who are most likely to benefit from targeted therapies
Genetics Test Information
This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of common EGFR mutations in exons 18, 19, 20, and 21 in patients with non-small cell lung cancer and can be used to assess eligibility for targeted therapies. Current data suggests that the efficacy of EGFR-targeted therapy in non-small cell lung cancer patients is limited to patients whose tumors harbor mutations in the EGFR gene.
This test is not validated for serial monitoring of patients with cancer. This test is also not intended as a screening test to identify cancer.
Method Name
Quantitative Polymerase Chain Reaction (PCR) Analysis
Reporting Name
cfDNA EGFR Mutation Analysis, BloodSpecimen Type
Plasma EDTASpecimen Minimum Volume
2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Frozen | 365 days |
Day(s) and Time(s) Performed
Monday through Friday; Varies
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved or is exempt by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
81235
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| EGFRD | cfDNA EGFR Mutation Analysis, Blood | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 113403 | Result Summary | 50397-9 |
| 113404 | Result | 82939-0 |
| 113405 | Interpretation | 69047-9 |
| 113406 | Additional Information | 48767-8 |
| 113407 | Specimen | 31208-2 |
| 113408 | Source | 31208-2 |
| 113409 | Released By | 18771-6 |