Bionano Announces Publication from Sanford Burnham Prebys Medical Discovery Institute Describing use of OGM to Detect Genomic Alterations Introduced by Gene Editing Technologies
SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (NASDAQ:BNGO) announced a peer-reviewed study published in Molecular Therapy - Methods & Clinical Development, describing the application of optical genome mapping (OGM) to detect genomic alterations introduced by different gene editing technologies, including transposons, lentiviral transduction, and CRISPR-Cas9-mediated locus insertion. The results suggest that OGM could be a valuable tool for quality control (QC) of cell-line genome integrity that identifies potentially deleterious alterations in pre-clinical and clinical development of gene editing therapies.
OGM was selected as a genome-wide, unbiased method to detect large genomic rearrangements and structural variants (SVs) with sensitivity to variant allele fractions (VAFs) as low as 5% to analyze human induced pluripotent stem cell (iPSC) lines before and after treatment with different gene editing methods. The study found that the number of transgene insertions was variable and dependent on the technology used for editing the cell lines. Transposons or lentiviral transduction resulted in a high number of transgene insertions in the genome, while CRISPR-Cas9 technology resulted in transgene insertion that was more precise and limited. In addition, the study showed that OGM can outperform traditional cytogenetic and sequencing-based methods in detecting complex and cryptic SVs and revealed previously undetected structural rearrangements and copy number changes present only in the engineered cells, suggesting that editing processes can introduce potentially pathogenic off-target genomic alterations that may escape detection.
"OGM is increasingly recognized as a powerful alternative to traditional cytogenetics in research applications such as studies of hematologic malignancies and constitutional genetic disease. For cell and gene therapy development in the pharmaceutical industry, assessment of genome integrity is fundamental to the safety and reliability of developing engineered cell products," said Erik Holmlin, PhD, president and chief executive officer of Bionano. "This study shows that optical genome mapping can uncover relevant structural variants and rearrangements that other methods miss, which supports the integration of OGM as a complementary QC tool to strengthen confidence in genome integrity, genetic fidelity, and long-term stability of edited cell lines in therapeutic development pipelines."
The full research publication, Unveiling Genomic Rearrangements in Engineered iPSC Lines by Optical Genome Mapping, is available at: https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(25)00239-6
About Bionano Genomics
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. All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as "can," "may," "potential," or "suggest" 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 the of OGM to be a valuable tool for QC of cell-line genome integrity that identifies potentially deleterious in pre-clinical and clinical development of gene editing therapies; the ability and utility of OGM to outperform traditional cytogenetic and sequencing-based methods in detecting complex and cryptic SVs and revealed previously undetected structural rearrangements and copy number changes present only in engineered cells; the ability and utility of OGM to uncover SVs and rearrangements that other methods miss; the ability and utility of OGM to be a complementary QC tool to strengthen confidence in genome integrity, genetic fidelity, and long-term stability of edited cell lines in therapeutic development pipelines; and our ability to drive adoption of OGM and our technology solutions for applications described in the publication referenced in this press release, and any other statements that are not of historical fact. Each of these forward-looking statements involves risks and uncertainties. Accordingly, investors and prospective investors are cautioned not to place undue reliance on these forward-looking statements as they involve inherent risk and uncertainty (both general and specific) and should note that they are provided as a general guide only and should not be relied on as an indication or guarantee of future performance. 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 risks and uncertainties associated with: the failure of OGM to be a valuable tool for QC of cell-line genome integrity that identifies potentially deleterious in pre-clinical and clinical development of gene editing therapies; the failure of OGM to outperform traditional cytogenetic and sequencing-based methods in detecting complex and cryptic SVs and revealed previously undetected structural rearrangements and copy number changes present only in engineered cells; the failure of OGM to uncover SVs and rearrangements that other methods miss; the failure of OGM to be a complementary QC tool to strengthen confidence in genome integrity, genetic fidelity, and long-term stability of edited cell lines in therapeutic development pipelines; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and 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; the impact of adverse geopolitical and macroeconomic events, and uncertain market conditions, including inflation, tariffs, and supply chain disruptions, on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; study results that differ or contradict the results mentioned in this press release; the risk that we are not able to complete a strategic transaction that would increase stakeholder value; and the risks and uncertainties associated with our business and financial condition in general, including the 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, our Quarterly Reports on Form 10-Q 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, except as may be required by law.
CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
[email protected]
Investor Relations:
Kelly Gura
Gilmartin Group
+1 (212) 229-6163
[email protected]
