Bionano Labs OGM test in line for Medicare coverage under proposed LCD
Bionano Laboratories, a wholly-owned subsidiary of Nasdaq-listed Bionano Genomics, has announced that MolDX, the programme that assesses molecular diagnostic technologies on behalf of Medicare Administrative Contractors, has issued a proposed Local Coverage Determination for genome-wide detection of copy number alterations and structural variants in hematologic neoplasms. The proposed LCD explicitly recognises optical genome mapping as a covered methodology and is open for public comment until 11 October 2026.
The draft policy would cover testing across a broad range of suspected hematologic malignancies, including leukaemias, lymphomas, and myelomas, at initial diagnosis, progression, or relapse. It states that a single genome-wide assay can deliver equivalent or superior clinically useful information compared with the combination of conventional karyotyping, fluorescence in situ hybridisation, and chromosomal microarray analysis. Bionano Laboratories has validated its OGM-Dx HemeOne diagnostic test for this indication and says it would be expected to qualify for coverage once the LCD is finalised and the laboratory completes the required technical assessment process.
Alex Hastie, chief scientific officer of Bionano and head of test development at Bionano Laboratories, said: "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."
Regulatory context
A proposed LCD from MolDX does not guarantee final coverage; the comment period allows clinical societies, payers, and manufacturers to submit evidence before a determination is issued. For Bionano, the pathway to reimbursement also requires satisfying the MolDX technical assessment process, which evaluates analytical and clinical validity. The company noted in its forward-looking disclosures that it is managing cash runway carefully and is reliant on significant additional financing, which makes the commercial timing of any coverage decision material to its near-term outlook.
The proposed LCD is also relevant beyond Bionano. Any genome-wide assay meeting the clinical utility criteria set out in the draft policy could in principle qualify, meaning the determination could accelerate broader adoption of next-generation cytogenomic tools across the sector.
Market landscape
The hematologic malignancy diagnostics market has historically been anchored by conventional karyotyping and FISH, both labour-intensive and limited in resolution. A number of academic centres and commercial laboratories have been building OGM and chromosomal microarray capabilities as genomic medicine guidelines have expanded the range of variants considered clinically actionable. If the LCD is finalised in its current form, it would represent a meaningful reimbursement precedent for genome-wide structural variant testing, potentially drawing additional commercial and investor interest into the optical mapping space. Bionano is currently the most visible commercial proponent of OGM in clinical diagnostics, though other technology approaches, including short-read and long-read sequencing platforms, are competing for a share of the same diagnostic workflow.