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Test ID T790M Cell-Free DNA EGFR T790M Mutation Analysis, Blood


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.

 

This test detects only the T790M mutation in the EGFR gene. It does not detect other EGFR gene mutations in exons 18 through 21. For that purpose, order EGFRD / Cell-Free DNA EGFR Exon 18, 19, 20, 21, Mutation Analysis, Blood.

 

This test provides rapid detection of the EGFR T790M mutation in peripheral blood from non-small cell lung cancer patients as an alternative for EGFR analysis of tissue. For tissue testing, order EGFRT / EGFR Gene, Mutation Analysis, 29 Mutation Panel, Tumor.



Shipping Instructions


1. Samples should be transported at ambient temperature or refrigerated (4° C)

2. Samples are viable for 7 days in the Streck Black/Tan Top Tube Kit (T715)



Specimen Required


Supplies: Streck Black/Tan Top Tube Kit (T-715)

Specimen Volume: Two 10-mL Streck Cell-Free DNA blood collection tubes

Additional Information:

1. Only blood collected in Streck Cell-Free DNA BCT tubes will be accepted for analysis. Whole blood will be processed to produce platelet poor plasma before cfDNA isolation.

2. Samples should be transported at room temperature or refrigerated (4° C)

3. Samples are viable for 7 days in the Streck Cell-Free DNA BCT tube.


Useful For

Determination of EGFR T790M mutation status in blood specimens as an alternative to invasive tissue biopsies

Identification of patients with non-small cell lung cancer who harbor a T790M mutation and may benefit from specific EGFR-targeted therapies

Genetics Test Information

This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of the EGFR T790M mutation in patients with non-small cell lung cancer (NSCLC) and can be used to assess eligibility for targeted therapies. Current data suggests that patients with metastatic NSCLC and the T790M mutation may benefit from T790M-targeted therapy (eg, osimertinib).

 

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.

Highlights

Evaluates peripheral blood for the presence of the T790M mutation in the EGFR gene in cell-free DNA

 

Rapid detection of the EGFR T790M mutation in non-small cell lung cancer patients as an alternative for EGFR analysis of tissue

 

Current data suggests that patients with metastatic NSCLC and the T790M mutation may benefit from T790M-targeted therapy (eg, osimertinib)

Method Name

Digital Droplet Polymerase Chain Reaction (PCR) of Plasma Cell-Free DNA

Reporting Name

cfDNA EGFR T790M Test, Blood

Specimen Type

Whole blood

Specimen Minimum Volume

One 10 mL Streck tube

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole blood Ambient (preferred) 7 days Streck Black/Tan top
  Refrigerated  7 days Streck Black/Tan top

Day(s) and Time(s) Performed

Monday through Friday; Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81235

LOINC Code Information

Test ID Test Order Name Order LOINC Value
T790M cfDNA EGFR T790M Test, Blood 55769-4

 

Result ID Test Result Name Result LOINC Value
113411 Result Summary 50397-9
113412 Result 55769-4
113413 Interpretation 69047-9
113414 Additional Information 48767-8
113415 Specimen 31208-2
113416 Source 31208-2
113417 Released By 18771-6

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.