Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics (NASDAQ: BNGO) has 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.
According to Bionano, 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.
In a statement, Alex Hastie, PhD, CSO of Bionano and responsible for overseeing test development at Bionano Laboratories, commented, “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. We look forward to participating in the public comment process as MolDX moves toward a final determination.”
