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 epidermal growth factor receptor (EGFR)-targeted therapies
This test evaluates cell-free DNA (cfDNA) in whole 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.
This test evaluates whole blood for the presence of the T790M mutation in the EGFR gene in cell-free DNA
This test provides rapid detection of the EGFR T790M mutation in non-small cell lung cancer patients as an alternative for EGFR analysis of tissue.
Droplet Digital Polymerase Chain Reaction (PCR)
NSCLC
Non-small cell lung cancer
Lung cancer
EGFR
Epidermal growth factor receptor
Cell free DNA
cfDNA
Circulating tumor DNA
Liquid biopsy
Circulating tumor cells
T790M
Cell-free DNA
Whole blood
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 whole blood specimens 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.
Supplies: Streck Black/Tan Top Tube Kit (T715)
Container/Tube: 10-mL Streck cell-free DNA (cfDNA) tubes
Specimen Volume: Two 10-mL Streck cfDNA tubes
Additional Information: Only blood collected in Streck Cell-Free DNA BCT will be accepted for analysis. Whole blood will be processed to produce platelet poor plasma before cfDNA isolation.
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
One 10 mL Streck tube
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Whole blood | Ambient (preferred) | 7 days | Streck Black/Tan top |
Refrigerated | 7 days | Streck Black/Tan top |
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 epidermal growth factor receptor (EGFR)-targeted therapies
This test evaluates cell-free DNA (cfDNA) in whole 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.
Epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitors (eg, gefitinib and erlotinib) have been approved by the US Food and Drug Administration (FDA) for use in treating patients with non-small cell lung cancer (NSCLC) who previously failed to respond to traditional chemotherapy. However, the EGFR T790M mutation is associated with acquired resistance to tyrosine kinase inhibitor (TKI) therapy in about 60% of patients with disease progression after initial response to erlotinib, gefitinib, or afatinib. Recent data suggest that patients with metastatic NSCLC and the T790M mutation may benefit from osimertinib, an FDA-approved oral TKI that inhibits both EGFR-activating mutations and the T790M mutation.
An interpretive report will be provided.
Patients with a negative test result may still harbor the EGFR T790M mutation. Mutation testing of a tissue specimen for EGFR mutations should be considered for patients with a negative result with this test.
The limit of detection of this assay for the detection of EGFR mutations is influenced by the amount of cell-free DNA in the blood. This is a biological variable that cannot be controlled.
This assay was designed to detect the following T790M mutation in the EGFR gene.
This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.
This test cannot differentiate between somatic and germline alterations.
This test has been evaluated by our laboratory as an alternative to assessing paraffin-embedded tumor specimens for the EGFR T790M mutation in patients with non-small cell lung cancer.
1. Schwarzenbach H, Hoon DS, Pantel K: Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer 2011;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;15(4):504-535
3. Janne PA, Yang JC, Kim DW, et al: AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015;372(18):1689-1699
Blood samples are collected in Streck Cell-Free DNA BC Tubes. Cell-free DNA is isolated from double spun plasma and assessed for the presence of the EGFR T790M mutation using digital droplet polymerase chain reaction.(Unpublished Mayo method)
Monday through Friday
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 US Food and Drug Administration.
81235
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
T790M | cfDNA EGFR T790M Test, Blood | 55769-4 |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
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 |