MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms

This LCD provides limited coverage for non‑NGS single-gene and multi-gene panel testing for the diagnostic evaluation of suspected BCR‑ABL‑negative myeloproliferative neoplasms when testing follows consensus diagnostic criteria. Covered tests must meet analytic sensitivity thresholds (e.g., JAK2 VAF ≥1%, CALR/MPL ~1–3%), follow a sequential reflex approach for single-gene testing, include minimum guideline-specified genes for the suspected subtype (e.g., JAK2, CALR, MPL; CSF3R for CNL), and demonstrate analytical/clinical validity and utility via technical assessment and peer‑reviewed evidence; NGS testing is outside this LCD and follows LCD L38047.

"Multi-gene non-NGS panel testing or single-gene testing is covered for the diagnostic workup of patients with suspected BCR-ABL-negative myeloproliferative neoplasms (MPNs), including classical MPN..."

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