MolDX, a program that assesses molecular diagnostic technologies on behalf of Medicare Administrative Contractors, issued a proposed Local Coverage Determination on Thursday that would establish Medicare coverage criteria for optical genome mapping in the workup of hematologic neoplasms.
The draft LCD would cover genome-wide assays that detect copy number alterations and structural variants when the results inform diagnosis or clinical management according to expert or professional guidelines. The proposed coverage applies to a broad range of suspected hematologic malignancies — including leukemias, lymphomas, and myelomas — at initial diagnosis, progression, or relapse.
MolDX stated that optical genome mapping can deliver clinically valid and useful genetic information for hematologic neoplasms that is comparable or superior to traditional methods such as conventional karyotyping and chromosomal microarray. A single optical genome mapping test can provide equivalent or greater genetic information than a combination of multiple traditional methodologies, including chromosomal breakage analysis, fluorescence in situ hybridization, and chromosomal microarray, according to MolDX.
Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics (NASDAQ:BNGO), validated the OGM-Dx HemeOne diagnostic test for hematologic malignancy analysis. The test is expected to be eligible for coverage under the proposed LCD once the policy is finalized and the lab satisfies the technical assessment process. Bionano Genomics is headquartered in San Diego.
"Patients with a hematologic malignancy depend on complete, accurate genomic information to guide their diagnosis and care," said Alex Hastie, chief scientific officer of Bionano.
The draft policy remains open for public comment through October 11, 2026.
