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The Multidisciplinary Team and EGFR Mutation Test Options at Initial Diagnosis

Testing for EGFR mutations takes teamwork

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According to the National Comprehensive Cancer Network® (NCCN®), epidermal growth factor receptor (EGFR) mutation testing is recommended for all patients who have been diagnosed with non–small cell lung cancer (NSCLC) and who are eligible for systemic therapy.1

Executing treatment plans in the era of biomarker-driven therapy requires coordination of care across all disciplines, including oncologists, nurses, pathologists, pulmonologists, interventional radiologists, and thoracic surgeons.2 Examples of health care professionals' roles in the EGFR mutation testing process are detailed in the figure below.

Accurate and Efficient EGFR Mutation Testing Requires a Multidisciplinary Team Approach2

Hover over each icon to learn more about that member of the multidisciplinary team.

An illustration showing individual members of a multidisciplinary team of health care providers along a patient’s EGFR testing journey, and the recommended turnaround time of 10 days for EGFR mutation test results.

An illustration showing individual members of a multidisciplinary team of health care providers along a patient’s EGFR testing journey, and the recommended turnaround time of 10 days for EGFR mutation test results.

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Identifying EGFR sensitizing mutations guides treatment decisions for newly diagnosed patients with NSCLC

Treatment for metastatic NSCLC may include surgical resection, radiation therapy for limited sites, or systemic treatment, including chemotherapy and targeted therapy.1 Mutation testing in metastatic disease, which is recommended for patients eligible for systemic treatment, may reveal the presence of biomarkers such as EGFR sensitizing mutations.1

The presence of EGFR sensitizing mutations can inform treatment options.

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EGFR tyrosine kinase inhibitors (EGFR-TKIs) are a standard first-line therapy option for patients with EGFR mutation–positive metastatic NSCLC.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend EGFR-TKIs as a first-line treatment for patients with EGFR mutation–positive metastatic NSCLC.1

Tests used to identify EGFR sensitizing mutations in newly diagnosed patients with NSCLC

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There are 2 categories of tests that are acceptable for use, according to the NCCN.1

FDA-approved tests

There are multiple FDA-approved diagnostic tests for the detection of EGFR sensitizing mutations (eg, exon 19 deletions, L858R) at diagnosis of NSCLC4:

Company

Test Name

Sample Type

Turnaround Time

Qiagen Manchester Ltd.5

therascreen® EGFR RGQ PCR Kit

Tissue*

Laboratory dependent

Roche6

cobas® EGFR Mutation Test v2

Tissue*/blood

7 days

Foundation Medicine7

FoundationOne CDx

Tissue*

<14 days

Thermo Fisher Scientific8

Oncomine Dx Target Test

Tissue*

4 days

Laboratory-developed tests

Laboratory-developed tests (LDTs) are required to adhere to performance specifications established by the Clinical Laboratory Improvement Amendments (CLIA) of 1988 under the regulation of the Centers for Medicare & Medicaid Services.9,10 LDTs are designed, manufactured, and used within a single laboratory.11

There are several LDTs that can also be used to test for EGFR sensitizing mutations.

Companies Offering LDTs for Detecting EGFR Sensitizing Mutations

Company

Test Name

Sample Type

Turnaround Time

Guardant Health12,13

Guardant360

Blood

14 days

Biodesix14,15

GeneStrat®

Blood

3 days

Sysmex Inostics16,17

OncoBEAM

Tissue*/blood

<10 days

Exosome Diagnostics18

ExoDx® Lung(T790M)

Blood

5 days

Biocept19

Biocept liquid biopsy

Blood

<7 days

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10 WORKING DAYS – The recommended turnaround time from the receipt of sample to the reporting of EGFR mutation test results according to guidelines from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP).3

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When ordering an EGFR mutation test, it is important to verify turnaround time when the order is placed. If the test results are taking longer than expected, work with your oncologist and pathologist to ensure results are received within the recommended 10 working-day period.3

*Formalin-fixed paraffin-embedded (FFPE) tissue samples are approved for testing.4

LDTs were developed and their performance characteristics determined by specific institutions in a manner consistent with CLIA requirements. They have not been cleared or approved by the Food and Drug Administration (FDA).

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Knowledge Checkpoint 2

A short quiz about EGFR testing at initial diagnosis and the multidisciplinary team

A short quiz about EGFR testing and the multidisciplinary team

Demonstrate your knowledge about the multidisciplinary team and the tests available to detect EGFR sensitizing mutations. To test your knowledge, register and complete this Knowledge Checkpoint. To begin, click below. in patients with newly diagnosed NSCLC. To begin, click below.

 
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The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non–Small Cell Lung Cancer V.2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed January 26, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Levy BP, Chioda MD, Herndon D, et al. Molecular testing for treatment of metastatic non-small cell lung cancer: how to implement evidence-based recommendations. Oncologist. 2015;20(10):1175-1181. doi:10.1634/theoncologist.2015-0114. 3. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346. doi:10.5858/arpa.2017-0388-CP. 4. US Food and Drug Administration. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm. Accessed February 21, 2018. 5. therascreen® EGFR RGQ PCR Kit [instructions for use (handbook)]. Manchester, UK: QIAGEN; 2017. 6. cobas® EGFR Mutation Test v2 [package insert]. Branchburg, NJ: Roche Molecular Systems, Inc.; 2015. 7. Foundation Medicine. FoundationOne CDx FAQs. Cambridge, MA: Foundation Medicine; 2017. https://www.foundationmedicine.com/genomic-testing/foundation-one-cdx. Accessed February 21, 2018. 8. Oncomine Dx Target Test Brochure. Waltham, MA: Thermo Fisher Scientific Inc.; 2017. 9. Fitzgibbons PL, Bradley LA, Fatheree LA, et al; College of American Pathologists Pathology and Laboratory Quality Center. Principles of analytic validation of immunohistochemical assays: guidelines from the College of American Pathologists Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2014;138(11):1432-1443. doi:10.5858/arpa.2013-0610-CP. 10. Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia. Updated April 5, 2017. Accessed February 26, 2018. 11. US Food and Drug Administration. Laboratory developed tests. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LaboratoryDevelopedTests/default.htm. Updated February 4, 2018. Accessed February 26, 2018. 12. Guardant Health. Guardant360 73-gene panel. http://www.guardanthealth.com/medical-professionals/#gene-panel. Accessed February 21, 2018. 13. Guardant Health. How Guardant360 works. http://www.guardanthealth.com/guardant360/#how-it-works. Accessed February 21, 2018. 14. Biodesix. GeneStrat® genomic test. http://www.biodesix.com/genestrat. Accessed February 21, 2018. 15. Clini