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Article ID Number: A54422 Status: A-Approved
Article Title: Billing and Coding: MolDX: FDA-Approved EGFR Tests
Original Article Effective Date:
10/01/2015
Revision Effective Date:
05/30/2024
Article Text:
Two tests have met the FDA criteria for EGFR genetic testing:
1. Effective 6/01/16
cobas EGFR Mutation Test is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.
The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the Table below in accordance with the approved therapeutic product labeling:
| Drug |
FFPET |
Plasma |
| TARCEVA®(erlotinib) |
Exon 19 deletions and L858R |
Exon 19 deletions and L858R |
| TAGRISSO™ (osimertinib) |
T790M |
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Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.
2. Effective 7/12/13
therascreen EGFR RGQ PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue to help select patients with NSCLC for whom GILOTRIF™ (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.
To report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information:
- CPT® code 81235
- Enter the appropriate DEX Z-Code® identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Item 19 for paper claim
- Enter the appropriate DEX Z-Code® identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- ICD-10-CM codes
NOTE: MolDX will apply NPI to ID editing on FDA approved EGFR kits. All labs that submit claims for an EGFR kit MUST register the test and confirm the UNMODIFIED use of the kit.
This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
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