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HelpTest Code T790M Cell-Free DNA EGFR T790M Mutation Analysis, Blood
Ordering Guidance
This test is not a prenatal screening test.
This test detects only the T790M mutation in the EGFR gene. It does not detect other EGFR gene mutations in exons 18 through 21.
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 EGFRS / EGFR Gene, Targeted Mutation Analysis, 51 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 (T715)
Specimen Volume: Two, 10-mL Streck cell-free DNA (cfDNA) blood collection tubes
Additional Information:
1. Only blood collected in Streck cfDNA tubes will be accepted for analysis.
2. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.
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
Method Name
Droplet Digital Polymerase Chain Reaction (ddPCR)
Reporting Name
cfDNA EGFR T790M Test, BloodSpecimen Type
Whole bloodSpecimen 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 |
Interpretation
The interpretation of molecular biomarker analysis includes an overview of the results and the associated therapeutic implications.
Clinical Reference
1. Schwarzenbach H, Hoon DSB, Pantel K: Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-437
2. Ettinger DS, Wood DE, Aisner DL, et al: Non-Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Apr;15(4):504-535
3. Janne PA, Yang JCH, Kim DW, et al: AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1689-1699
Day(s) Performed
Varies
Report Available
5 to 10 daysPerforming 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. It has not been cleared or approved by the US 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 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
Reference Values
An interpretive report will be provided.