Bionano Announces French Publication of an Effective Method for Analysis of Multiple Myeloma by OGM

SAN DIEGO, April 08, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (NASDAQ:BNGO) today announced a study published in The Journal of Molecular Diagnostics that describes a method for analysis of multiple myeloma (MM) by optical genome mapping (OGM). MM is one of the most common blood cancers, or hematologic malignancies, and is understood to be a difficult sample to analyze using traditional cytogenetics. Direct analysis of MM samples, by methods such as FISH or OGM, can be problematic because it is challenging to isolate enough cells with a known MM marker (CD138) on their surface, so-called CD138-positive cells. In this paper, researchers at Institute of Medical Genetics, Lille University Hospital, Lille, France, have described a method for OGM that can overcome the hurdle of limited sample quantity and can cut in half the effective CD138-positive cell requirement for analysis by OGM.

Key Findings and Takeaways

• Mixing CD138-positive with CD138-negative cells from the same sample at a ratio of 1:1 can be sufficient to perform OGM. Since OGM typically requires 1 million cells, this finding suggests that as few as 0.5 million of the CD138-positive cells are sufficient
  
  
  
  
• OGM reveals More Genetic Events: Achieving 93% (13/15) concordance with FISH, the current standard, OGM also uncovered more than 22 additional genetic variants that were previously undetected by FISH
  
  
  
  
• OGM Streamlines the Analysis: Consolidating multiple assessments (KT and multiple FISH assays) into a single, comprehensive approach using OGM can be more efficient and maximize the value of scarce cell samples while simplifying laboratory workflows and reducing the need for separate, time-consuming tests
  
  
  
  
• OGM Improves Prognostic Risk Evaluation: By capturing both primary and novel potentially pathogenic variants, OGM provides a comprehensive genomic profile that can be used to support more precise prognostic risk stratification
  
  

"Multiple myeloma is one of the most requested cancer types by customers seeking to implement OGM in routine use. We believe this publication marks an important advancement for OGM research in hematologic malignancies. The senior author, Dr Daudignon, has been among the pioneers spearheading the adoption of OGM in France through the French Optical Genome Mapping Group (FrOGG) and has included OGM as an alternative to legacy cytogenetic methods on behalf of the Groupe Francophone de Cytogénétique Hématologique (GFCH) for the evaluation of MM. This simple approach to OGM analysis of MM can offer the opportunity for researchers to expand their OGM menus to include a prevalent blood cancer with a significant unmet medical need," commented Erik Holmlin, PhD, president and chief executive officer of Bionano.

The full research publication is available at: https://www.jmdjournal.org/article/S1525-1578(25)00035-2/fulltext

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.

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

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 "believe," "can," "may" 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 describe future expectations, plans, results, or strategies, among other things, and in this release include, but are not limited to, statements regarding OGM's ability to produce concordant results with FISH and other traditional cytogenetic methods for analyzing MM samples; the ability of OGM to identify new genetic variants for MM not identified with traditional cytogenetic methods; the ability of OGM to be more efficient than traditional cytogenetic methods; the ability to achieve results similar to those referenced in this press release using the methods described therein; the importance of the publication referenced in this press release to prove to be an important advancement in MM research; the ability and utility of the method described in this press release to further open researchers' ability to expand their OGM menu; and other statements that are not historical fact. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. 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 recent and future bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East and related sanctions and any regional or global pandemics, on our business and the global economy; the failure of OGM to produce concordant results with FISH and other traditional cytogenetic methods for analyzing MM samples; the failure of OGM to identify new genetic variants for MM not identified with traditional cytogenetic methods; the failure of OGM to be more efficient than traditional cytogenetic methods; the inability to achieve results similar to those referenced in this press release using the methods described therein; the failure of the publication referenced in this press release to prove to be an important advancement in MM research; the failure of the method described in this press release to further open researchers' ability to expand their OGM menu; future publications that contradict the findings of the publication referenced in this press release; the failure of our ability to drive adoption and utilization of optical genome mapping as a replacement to traditional cytogenetic techniques; challenges inherent in developing, manufacturing and commercializing products; our ability to further deploy new products and applications for our technology platforms; our expectations and beliefs regarding future growth of the business and the markets in which we operate; 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; our ability to consummate any strategic alternatives; 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 report 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 are under no duty to update any of these forward-looking statements after the date they are made to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date the statements are made. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this press release.

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]