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Test ID EGFRD EGFR Exon 18, 19, 20, 21, Mutation Analysis, Cell-Free DNA


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, Blood

Specimen Type

Plasma EDTA

Specimen 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 or approved 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

NY State Approved

No