MolDX proposes Medicare coverage for genome-wide hematologic testing

Bionano Laboratories, a subsidiary of Bionano Genomics (Nasdaq: BNGO), announced that MolDX has issued a proposed Local Coverage Determination (LCD) that would establish Medicare coverage criteria for genome-wide molecular testing, including optical genome mapping (OGM), in the workup of hematologic neoplasms.

The proposed LCD covers genome-wide assays that detect copy number alterations and structural variants when testing informs diagnosis or clinical management in line with current professional guidelines. The policy applies to a range of suspected hematologic malignancies, including leukemias, lymphomas, and myelomas, at initial diagnosis, progression, or relapse.

The draft LCD states that "it has been adequately proven that a single test may provide equivalent or greater clinically valid and useful genetic information as could be achieved by the combination of multiple traditional methodologies (including CBA, FISH, and CMA)."

Bionano Laboratories has validated its OGM-Dx HemeOne diagnostic test for hematologic malignancy analysis. The company stated the test would be expected to be eligible for coverage under the proposed LCD once finalized and once the lab completes the required technical assessment process.

The proposed LCD is open for public comment through October 11, 2026.

Alex Hastie, Ph.D., chief scientific officer of Bionano, said the proposed coverage determination "is an important acknowledgment that tests, such as our OGM-Dx HemeOne, can deliver that information in a single test."

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