The draft Local Coverage Determination establishes criteria for genome-wide structural variant assays across leukemias, lymphomas, and myelomas.
MolDX has issued a proposed local coverage determination (LCD) that would establish Medicare coverage criteria for optical genome mapping (OGM) and other genome-wide molecular methodologies in the evaluation of hematologic neoplasms, according to an announcement from Bionano Laboratories.
The draft LCD, titled “Genome-Wide Molecular Methodologies for the Detection of Copy Number Alterations and Structural Variants in Hematologic Neoplasms,” is open for public comment through Oct 11, 2026. MolDX evaluates molecular diagnostic technologies on behalf of Medicare Administrative Contractors.
Coverage Criteria for Genome-Wide Assays
Under the proposed policy, Medicare would provide coverage for genome-wide assays that detect copy number alterations and structural variants when testing informs clinical management or diagnosis in accordance with professional guidelines, according to Bionano Laboratories.
The draft policy covers testing for a broad range of suspected hematologic malignancies, including leukemias, lymphomas, and myelomas, at initial diagnosis, progression, or relapse.
According to the press release, the draft determination recognizes that single genome-wide methodologies can match or exceed the performance of conventional multi-test cytogenetic workflows. 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).”
Impact on Laboratory Developed Tests
The proposed LCD indicates that approaches including OGM can deliver clinically valid genetic information that is comparable or superior to traditional methods like chromosomal microarray and conventional karyotyping, Bionano Laboratories reported.
Bionano Laboratories stated that it has validated its OGM-Dx HemeOne laboratory developed test for hematologic malignancy analysis. The test is expected to become eligible for coverage once the LCD is finalized and the laboratory completes the required MolDX technical assessment process, according to the company.
“Patients with a hematologic malignancy depend on complete, accurate genomic information to guide their diagnosis and care, and this proposed coverage determination is an important acknowledgment that tests, such as our OGM-Dx HemeOne, can deliver that information in a single test,” says Alex Hastie, PhD, chief scientific officer of Bionano and responsible for overseeing test development at Bionano Laboratories, in a release. “We look forward to participating in the public comment process as MolDX moves toward a final determination.”
