Billing and Coding: MolDX: FDA-Approved EGFR Tests

MolDX recognizes two FDA-approved EGFR test kits—cobas EGFR Mutation Test and therascreen EGFR RGQ PCR kit—as companion diagnostics to guide targeted therapy in NSCLC per FDA labeling. cobas supports testing of FFPET and plasma cfDNA for EGFR exon 19 deletions and L858R (plasma-positive results allow erlotinib; plasma negatives require reflex to FFPET), and detection of T790M informs osimertinib treatment; therascreen is indicated on tumor tissue to select patients for afatinib. Claims must use CPT 81235 with the appropriate DEX Z-Code entered in specified claim fields, and laboratories must register the test and confirm unmodified kit use for coverage.

"Use cobas EGFR Mutation Test on formalin-fixed paraffin-embedded tumor tissue (FFPET) from patients with non-small cell lung cancer (NSCLC) to detect EGFR exon 19 deletions or L858R mutations to gu..."

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