Billing and Coding: MolDX: FDA-Approved EGFR Tests

FDA-approved cobas EGFR Mutation Test v2 and therascreen EGFR RGQ PCR kit are covered as companion diagnostics for detecting EGFR mutations in NSCLC to guide FDA-labeled targeted therapies (erlotinib, afatinib, osimertinib) using FFPET or plasma cfDNA specimens per test labeling. Claims must use CPT 81235, include the appropriate DEX Z-Code in specified claim fields, submit ICD-10-CM diagnosis codes, and laboratories must register the test with MolDX and confirm unmodified kit use; a negative plasma result for exon 19 deletions or L858R requires reflex testing on FFPET.

"The cobas EGFR Mutation Test v2 is indicated as a companion diagnostic to detect defined EGFR mutations in patients with non-small cell lung cancer (NSCLC) using DNA from formalin-fixed paraffin-em..."

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