Bionano Laboratories Announces Proposed Local Coverage Determination (LCD) from MolDX for Genome-Wide Detection of Structural Variants in Hematologic Neoplasms

SAN DIEGO, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (Nasdaq: BNGO) that offers CLIA-certified laboratory developed test (LDTs), today 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. 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.

The draft LCD would provide coverage for genome-wide assays that detect copy number alterations and structural variants when testing informs diagnosis or clinical management in accordance with current expert or professional guidelines. The proposed policy recognizes that these approaches, including OGM, can deliver clinically valid and useful genetic information for hematologic neoplasms that are comparable or superior to traditional methods such as conventional karyotyping and chromosomal microarray. Bionano Laboratories has validated the OGM-Dx™ HemeOne diagnostic test for hematologic malignancy analysis, which would be expected to be eligible for coverage under this proposed LCD once finalized and once the lab satisfies the technical assessment process. The proposed LCD is available here.

This proposed LCD would cover a broad range of suspected hematologic malignancies including leukemias, lymphomas, and myelomas at time of 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).”

"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," said Alex Hastie, Ph.D., chief scientific officer of Bionano and responsible for overseeing test development at Bionano Laboratories. "We look forward to participating in the public comment process as MolDX moves toward a final determination."

About Bionano Laboratories:
Lineagen, Inc. d/b/a Bionano Laboratories provides access to genetic answers and support utilizing cutting-edge technologies to advance the way the world sees the genome. Its clinical diagnostics services offer optical genome mapping (OGM) testing that combines a comprehensive testing portfolio with thoughtful and accessible support options. Bionano Laboratories also offers direct access to OGM for applications across basic, translational and clinical research. For more information, visit www.bionanolaboratories.com

About Bionano
Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for clinical, translational, medical, and basic research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com 

Bionano's products are for research use only and not for use in diagnostic procedures.

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CONTACTS
Investor Relations:
Webb Campbell
Gilmartin Group
+1 (415) 520-5817
IR@bionano.com