Bionano Laboratories Announces Publication of the Largest Study To-Date Evaluating Clinical Utility of Optical Genome Mapping Across Multiple Hematologic Malignancies

• In 58% or 303 of 519 cases, optical genome mapping (OGM) revealed somatic aberrations that were not detected by the standard cytogenetic workup (SCGW), including Tier 1, Tier 2 and Tier 3 structural variants (SVs) and copy number variants (CNVs)
  
  
• In 15% or 75 of 519 cases, OGM identified additional Tier 1 variants with detection rates varying by disease type, ranging from 52% in T-ALL to 0% in MPN. Every Tier 1 SV or CNV detected by OGM had direct diagnostic, prognostic, or therapeutic significance, meaning that the detection would provide additional clinical utility
  
  

SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (NASDAQ:BNGO) that offers CLIA-certified laboratory developed tests (LDTs) based on optical genome mapping (OGM), today announced a publication from The University of Texas MD Anderson Cancer Center describing the largest study to-date to evaluate the clinical utility of OGM as an additional tool in the standard cytogenetic workup (SCGW) of hematologic malignancies.

Study Overview:

Cohort: 519 bone marrow and/or peripheral blood samples collected prospectively in a single institution and analyzed retrospectively

Hematological malignancy subtypes evaluated: T-lymphoblast leukemia (T-ALL), mixed phenotype acute leukemia (MPAL), B-lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), multiple myeloma, mantle cell lymphoma (MCL), myelodysplastic/myeloproliferative neoplasms (MPN), myelodysplastic syndrome (MDS)

Evaluation of OGM's additional clinical value: The value of OGM was assessed by comparing OGM findings to those of SCGW in two key aspects: (1) analytical sensitivity—defined as all additional somatic aberrations (Tier 1*, Tier 2*, and Tier 3* structural variants (SVs) and copy number variants (CNVs) detected exclusively by OGM; and (2) clinical utility—defined as Tier 1 SVs/CNVs detected solely by OGM, which have diagnostic, prognostic, or therapeutic significance.

Findings:

(1)	OGM can enhance analytical sensitivity over that of SCGW. In 58% or 303 of 519 cases, OGM revealed somatic aberrations that were not detected by the SCGW, including Tier 1, Tier 2 and Tier 3 SVs and CNVs
(2)	OGM can enhance the clinical utility of SCGW. OGM identified additional Tier 1 variants in 15% or 75 of 519 cases, with detection rates varying by disease type, ranging from 52% in T-ALL to 0% in MPN. Every Tier 1 SV or CNV detected by OGM had direct diagnostic, prognostic, or therapeutic significance, meaning that the detection provided additional clinical utility

"This study represents the largest single-institution evaluation of the clinical utility of optical genome mapping in hematologic malignancies conducted to date, and we believe the results have the ability to be a game-changer for clinical cytogenetics. The fact that this study reports that OGM uncovered clinically actionable Tier 1 variants in 15% of cases and pathogenic or likely pathogenic variants in 58% of cases overall that were missed by conventional methods like karyotyping and FISH, highlights a significant gap in current diagnostic workflows. Missing these structural variants—many of which can directly impact diagnosis, prognosis, or therapy decisions—is a major shortcoming that can adversely affect patient management and outcomes. Integrating OGM-based tests, such as our OGM-Dx™ HemeOne assay, into routine use offers a potential pathway to closing this gap, and may help ensure that patients receive the most accurate and comprehensive genomic analysis available," commented Dr Alka Chaubey, PhD, FACMG, chief medical officer of Bionano.

*Tier 1 variants are those with established diagnostic, prognostic or therapeutic relevance as acknowledged in clinical practice guidelines. Tier 2 variants are those with some clinical relevance but do not satisfy all criteria to be Tier 1 and Tier 3 variants are those that cannot be classified in either Tier 1 or Tier 2 but also cannot be deemed to be benign or likely benign.

The article is part of the Special Issue "Diagnostic Biomarkers in Cancers Study" and is available at: https://www.mdpi.com/2072-6694/17/9/1436

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 applications across basic, translational and clinical 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 or www.bionanolaboratories.com.

Forward-Looking Statements of Bionano Genomics

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "ability," "believe," "can," "may," "potential," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the ability and utility of OGM to be an additional tool in the SCGW of hematologic malignancies; the ability and utility of OGM to detect Tier 1, Tier 2, and Tier 3 SVs and CNVs in hematologic malignancies not detected by traditional cytogenetic methods, such as karyotyping and FISH; the ability of OGM to enhance analytical sensitivity over that of SCGW; the ability of OGM to enhance the clinical utility of SCGW; the ability of OGM to be a game-changer for clinical cytogenetics; the ability of SVs and CNVs detected by OGM to impact diagnosis, prognosis, or therapy decisions; the ability of the OGM-Dx HemeOne assay to detect SVs and CNVs in a manner similar to the methods reported in publication referenced in this press release; the ability and utility of OGM to become integrated into the SCGW for hematologic malignancies; and the ability of OGM to be implemented in clinical settings. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the impact of adverse geopolitical and macroeconomic events, such as bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East and related sanctions, regional or global pandemics, uncertain market conditions, including tariffs and inflation, and supply chain disruptions on our business and the global economy; the failure of OGM to be an additional tool in the SCGW of hematologic malignancies; the failure of OGM to detect Tier 1, Tier 2, and Tier 3 SVs and CNVs in hematologic malignancies not detected by traditional cytogenetic methods, such as karyotyping and FISH; the failure of OGM to enhance analytical sensitivity over that of SCGW; the failure of OGM to enhance the clinical utility of SCGW; the failure of OGM to be a game-changer for clinical cytogenetics; the failure of SVs and CNVs detected by OGM to impact diagnosis, prognosis, or therapy decisions; the failure of the OGM-Dx HemeOne assay to detect SVs and CNVs in a manner similar to the methods reported in publication referenced in this press release; the failure of OGM to become integrated into the SCGW for hematologic malignancies; the failure of OGM to be implemented in clinical settings; future publications contradicting the results reported in the publication referenced in this press release; general market conditions; changes in our strategic and commercial plans; our ability to continue as a "going concern," which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; and other risks and uncertainties including those described in our filings with the Securities and Exchange Commission ("SEC"), including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings subsequently made by us with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS

Company Contact:

Erik Holmlin, CEO

Bionano Genomics, Inc.

+1 (858) 888-7610

[email protected]

Investor Relations:

David Holmes

Gilmartin Group

+1 (858) 888-7625

[email protected]