Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (NASDAQ:BNGO) that offers CLIA-certified laboratory developed test (LDTs), today announced that MolDX, a program that assesses molecular diagnostic technologies on behalf of Medicare Administrative Contractors (MACs), has issued a proposed Local Coverage Determination (LCD) for Genome-Wide Molecular Methodologies for the Detection of Copy Number Alterations and Structural Variants in Hematologic Neoplasms. The LCD would establish Medicare coverage criteria for molecular testing, including optical genome mapping (OGM), in the workup of hematologic neoplasms. The proposed LCD is open for public comment through October 11, 2026.

The draft LCD would provide coverage for genome-wide assays that detect copy number alterations and structural variants when testing informs diagnosis or clinical management in accordance with current expert or professional guidelines. The proposed policy recognizes that these approaches, including OGM, can deliver clinically valid and useful genetic information for hematologic neoplasms that are comparable or superior to traditional methods such as conventional karyotyping and chromosomal microarray. Bionano Laboratories has validated the OGM-Dx™ HemeOne diagnostic test for hematologic malignancy analysis, which would be expected to be eligible for coverage under this proposed LCD once finalized and once the lab satisfies the technical assessment process.