Bionano Announces Publication Reporting First Use of OGM to Detect Chromoanagenesis, a Key Marker of Poor Prognosis in AML

• In-Motion Webinar: Bionano will host a webinar featuring the study’s lead author, Dr. Guilin Tang, who will discuss the study and its findings in detail, including a summary of the potential implications for wide-spread adoption of optical genome mapping
• Time and Date: April 15, 2025 at 9:30 AM Central Time, USA
• Registration details to be made available at Bionano.com
  

/EIN News/ -- SAN DIEGO, March 13, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a study published in the American Journal of Hematology demonstrating the potential utility of optical genome mapping (OGM) for detecting structural variants associated with chromoanagenesis (CAG) in acute myeloid leukemia (AML). CAG is a catastrophic genomic event that is frequently associated with highly complex karyotypes, extensive clonal heterogeneity, treatment resistance, and poor prognosis compared to subjects with no detectable CAG. Based on the OGM findings, clinical researchers found higher than anticipated rates of CAG in AML (16% of cases overall and approximately two-thirds of cases with high-risk cytogenetic profiles), suggesting that OGM may be more sensitive than traditional cytogenetic methods in identifying aggressive forms of AML.

This study analyzed a prospectively collected cohort of 410 AML cases. It was led by Dr. Guilin Tang, and a team of experts from the MD Anderson Cancer Center, and is the first study known to utilize OGM to study CAG.

Key Findings:

• CAG was identified in 16% of AML samples and correlated with highly complex karyotypes (92%), monosomal karyotypes (88%), and TP53 mutations (92%)
• The median survival for AML subjects with CAG was only 5 months, compared to 14 months in those without CAG
• Subjects with CAG had a significantly lower response to combination therapy
• OGM provided high resolution and sensitivity in detecting these catastrophic chromosomal events, reinforcing its potential to provide an alternative to refine AML risk stratification and guide treatment planning

Erik Holmlin, president and CEO of Bionano commented, “The critical mass of publications underscoring the concordance of OGM with traditional cytogenetics has been established. This impressive study is among a new class of research that is beginning to show the incremental value that OGM can provide above and beyond the standard cytogenetic methods. Using OGM to detect markers like CAG, which is associated with a lower median survival rate and a lower response to therapy, holds the promise that more people with devastating diseases like AML could potentially have access to appropriate therapy sooner.”

The full research publication is available at: https://onlinelibrary.wiley.com/doi/10.1002/ajh.27575

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 “could,” “may,” “potential,” “will” 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 identify structural variants associated with CAG, the ability and utility of OGM to be more sensitive that traditional cytogenetic methods; the utility of OGM data in the analysis of AML samples; the potential ability and utility of OGM to refine AML risk stratification and guide treatment planning; the utility of OGM for applications in areas reported in this press release; the growth and potential use of OGM for research applications as reported in this press release; and other states 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’s ability to identify structural variants associated with CAG; the failure of OGM to be more sensitive that traditional cytogenetic methods; the failure of OGM data to prove useful in the analysis of AML samples; the failure of OGM to refine AML risk stratification and guide treatment planning; the failure of OGM to prove useful for applications in areas reported in this press release; the failure of OGM use to grow in the research applications as reported in this press release; 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, 2023 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
eholmlin@bionano.com