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Bionano Laboratories Announces Expansion of Diagnostic Testing Based on Optical Genome Mapping for Hematologic Malignancies

Wed, 23 Sep 2026 09:00:00 -0400

SAN DIEGO, Sept. 23, 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 expansion of optical genome mapping (OGM) based testing of hematologic malignancies at Memorial Sloan Kettering Cancer Center (MSK), following approval from the New York State Department of Health (NYSDOH).

Hematologic cancers, including acute leukemias, myelodysplastic syndromes (MDS), plasma cell neoplasms (PCN), and lymphoid malignancies, frequently harbor complex genomic rearrangements that can be challenging to fully characterize using traditional cytogenetic methods. Numerous publications have shown evidence supporting the use of

Bionano Laboratories Announces Expansion of Diagnostic Testing Based on Optical Genome Mapping for Hematologic Malignancies

Wed, 23 Sep 2026 09:00:00 -0400

Three studies back Bionano's optical genome mapping in blood cancers

Mon, 14 Sep 2026 09:01:01 -0400

Bionano Genomics (Nasdaq: BNGO) highlighted three peer-reviewed studies published in September 2026 that examined the clinical utility of its optical genome mapping (OGM) technology in myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and therapy-related myeloid neoplasms (t-MN).

The first study, from MD Anderson Cancer Center and published in Modern Pathology, analyzed 332 MDS samples and identified chromoanagenesis — a form of catastrophic genomic restructuring — in 15.9% of cases. Patients positive for the condition had a median overall survival of 9.9 months, compared with a median that was not reached in those without it.

The second study, from the University of Oulu

Bionano Announces Three New Peer-Reviewed Studies Demonstrate Clinical Value of Bionano's Optical Genome Mapping Across Myelodysplastic Syndromes and Acute Myeloid Leukemia

Mon, 14 Sep 2026 09:00:00 -0400

Independent research teams at MD Anderson Cancer Center, the University of Oulu, and the Josep Carreras Leukaemia Research Institute report that optical genome mapping (OGM) uncovers clinically significant genomic alterations missed by conventional cytogenetics, with direct implications for risk stratification across MDS, AML, and therapy-related myeloid neoplasms

Bionano Announces Three New Peer-Reviewed Studies Demonstrate Clinical Value of Bionano's Optical Genome Mapping Across Myelodysplastic Syndromes and Acute Myeloid Leukemia

Mon, 14 Sep 2026 09:00:00 -0400

Bionano Announces Three New Peer-Reviewed Studies Demonstrate Clinical Value of Bionano's Optical Genome Mapping Across Myelodysplastic Syndromes and Acute Myeloid Leukemia

Mon, 14 Sep 2026 09:00:00 -0400

SAN DIEGO, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today highlighted three new independently authored, peer-reviewed publications demonstrating the clinical utility of OGM in high-risk hematologic malignancies — myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and therapy-related myeloid neoplasms (t-MN). The studies, published in Modern Pathology, the International Journal of Cancer, and npj Precision Oncology, reinforce a growing body of evidence that OGM can detect prognostically important structural genomic alterations that elude standard karyotyping, FISH, and targeted sequencing panels.

MD Anderson Cancer Center: Chromoanagenesis by OGM defines an ultra-high-risk MDS subset.

Researchers

Bionano Announces Three New Peer-Reviewed Studies Demonstrate Clinical Value of Bionano's Optical Genome Mapping Across Myelodysplastic Syndromes and Acute Myeloid Leukemia

Mon, 14 Sep 2026 09:00:00 -0400

MD Anderson Cancer Center: Chromoanagenesis by OGM defines an ultra-high-risk MDS subset.

Researchers

Form 8-K Bionano Genomics, Inc. For: Sep 14

Mon, 14 Sep 2026 08:31:00 -0400

si-local-file:///var/storage/secattach/20260914/27055916.html

MolDX proposes Medicare coverage for genome-wide hematologic testing

Thu, 10 Sep 2026 09:02:59 -0400

Bionano Laboratories, a subsidiary of Bionano Genomics (Nasdaq: BNGO), announced that MolDX has issued a proposed Local Coverage Determination (LCD) that would establish Medicare coverage criteria for genome-wide molecular testing, including optical genome mapping (OGM), in the workup of hematologic neoplasms.

The proposed LCD covers genome-wide assays that detect copy number alterations and structural variants when testing informs diagnosis or clinical management in line with current professional guidelines. The policy applies to a range of suspected hematologic malignancies, including leukemias, lymphomas, and myelomas, at initial diagnosis, progression, or relapse.

The draft LCD states that "it has been adequately proven that a single

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

Thu, 10 Sep 2026 09:00:00 -0400

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

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

Thu, 10 Sep 2026 09:00:00 -0400

Bionano Laboratories Announces New York State Department of Health Approval of Lab Developed Tests Based on Optical Genome Mapping

Tue, 08 Sep 2026 09:00:00 -0400

New York State Department of Health approval allows clinical use of optical genome mapping (OGM) based lab developed tests (LDTs) for patients with suspected genetic disease, reproductive disorders, and hematologic malignancies at University of Rochester Medicine

SAN DIEGO, Sept. 08, 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 the New York State Department of Health (NYSDOH) has approved the use of optical genome mapping (OGM)-based LDTs for the clinical evaluation of samples from patients suspected of various genetic disorders including reproductive disorders

Bionano Laboratories Announces New York State Department of Health Approval of Lab Developed Tests Based on Optical Genome Mapping

Tue, 08 Sep 2026 09:00:00 -0400

Bionano to Participate in the H.C. Wainwright 28th Annual Global Investment Conference

Mon, 24 Aug 2026 08:00:00 -0400

SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that management will present and host 1x1 meetings at the H.C. Wainwright 28th Annual Global Investment Conference on Monday, September 14, 2026.

Conference & Webcast Details

SAN DIEGO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today reported financial results for the second quarter ended June 30, 2026.

"Our second quarter results reflect a strong vote of confidence from our routine use customer community and the accelerating global adoption of optical genome mapping (OGM)," commented Al Luderer, Ph.D., chairman and interim chief executive officer of Bionano. "The evidence base supporting OGM continued to expand across a broad range of research areas, reflected by the year-over-year increase in OGM studies presented

Bionano Reports Second Quarter 2026 Results and Provides a Business Update

Mon, 10 Aug 2026 16:05:00 -0400

Conference call today, August 10, 2026, at 4:30 PM ET

SAN DIEGO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today reported financial results for the second quarter ended June 30, 2026.

Form 8-K Bionano Genomics, Inc. For: Aug 10

Mon, 10 Aug 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260810/26897753.html

Form 8-K Bionano Genomics, Inc. For: Aug 10

Mon, 10 Aug 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260810/26897753.html