Billing and Coding: MolDX: FDA-Approved KRAS Tests

MolDX recognizes two FDA‑approved KRAS test kits: therascreen® (detects seven somatic KRAS mutations) and cobas® (detects codon 12/13 mutations) for use in colorectal cancer patients to identify candidates for anti‑EGFR therapy (cetuximab and/or panitumumab). Claims must report the appropriate CPT with 1 unit of service, include the DEX Z‑Code in the specified claim fields, report the ICD‑10‑CM diagnosis, and submitting labs must register the test on DEX and confirm unmodified kit use; MolDX will use the laboratory NPI for ID editing.

"therascreen® KRAS kit is covered to detect seven somatic KRAS mutations in colorectal cancer (CRC) patients to identify candidates for treatment with cetuximab (Erbitux)."

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