Bionano Announces Publication from Sanford Burnham Prebys Medical Discovery Institute Describing use of OGM to Detect Genomic Alterations Introduced by Gene Editing Technologies

Rhea-AI Summary

Bionano Genomics (Nasdaq: BNGO) highlighted a peer-reviewed study showing optical genome mapping (OGM) can detect genomic alterations introduced by gene editing methods in human iPSC lines. The study reports OGM sensitivity to variant allele fractions as low as 5%, found variable transgene insertion counts by technology, and identified complex structural variants missed by traditional methods.

Findings suggest OGM may serve as a complementary QC tool to assess genome integrity and reveal potentially pathogenic off-target rearrangements in engineered cell lines used for therapeutic development.

Positive

• OGM sensitivity to 5% VAF
• OGM detected complex/cryptic SVs missed by other methods
• CRISPR-Cas9 produced more precise, limited transgene insertions

Negative

• Transposons and lentiviral transduction caused a high number of insertions
• Editing processes can introduce potentially pathogenic off-target alterations
• Variable transgene insertion counts depend on editing method

News Market Reaction

-1.25%

1 alert

-1.25% News Effect

-14.4% Trough Tracked

-$155K Valuation Impact

$12M Market Cap

0.7x Rel. Volume

On the day this news was published, BNGO declined 1.25%, reflecting a mild negative market reaction. Argus tracked a trough of -14.4% from its starting point during tracking. This price movement removed approximately $155K from the company's valuation, bringing the market cap to $12M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

VAF sensitivity: 5%

1 metrics

VAF sensitivity 5% Lowest variant allele fraction OGM detected in edited iPSC lines

Market Reality Check

Price: $1.09 Vol: Volume 499,773 is above t...

high vol

$1.09 Last Close

Volume Volume 499,773 is above the 20-day average of 286,780 (relative volume 1.74). high

Technical Shares at $1.20 are trading below the 200-day MA of $2.67 and about 81% under the 52-week high.

Peers on Argus

BNGO was down 5.51% while peers were mixed: HBIO +0.02%, RVP +2.63%, NXGL -7.52%...

BNGO was down 5.51% while peers were mixed: HBIO +0.02%, RVP +2.63%, NXGL -7.52%, FEMY -2.75%, MHUA -27.18%. This pattern points to stock-specific factors rather than a broad sector move.

Historical Context

5 past events · Latest: Jan 12 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Prelim 2025 results	Negative	+0.6%	Preliminary Q4 and FY2025 revenue declines versus prior year levels.
Dec 11	OGM conference recap	Positive	-1.2%	Multiple AMP 2025 studies showing OGM advantages across several indications.
Dec 03	Reimbursement increase	Positive	+3.0%	CMS raised CPT code 81195 payment by <b>47%</b> for OGM in hematologic malignancies.
Nov 13	Q3 2025 earnings	Positive	-8.1%	Q3 2025 revenue growth, improved margins and reduced operating expenses.
Nov 06	Clinical OGM study	Positive	-4.7%	MD Anderson study showing OGM can overcome limits of targeted RNA-seq in leukemia.

Pattern Detected

Recent news, especially positive OGM and reimbursement updates, has more often seen share price weakness or muted gains than sustained rallies.

Recent Company History

Over the last few months, Bionano has reported mixed financial and operational updates. Preliminary Q4 and FY2025 results on Jan 12 2026 showed modest revenue declines, while Q3 2025 results on Nov 13 2025 highlighted year-over-year revenue growth. Multiple publications and conference recaps underscored the capabilities of optical genome mapping, and a CMS decision on Dec 3 2025 raised reimbursement for OGM-related testing. Despite generally constructive technology news, share price reactions have frequently been negative or only modestly positive.

Market Pulse Summary

This announcement highlights peer-reviewed evidence that optical genome mapping can detect structura...

Analysis

This announcement highlights peer-reviewed evidence that optical genome mapping can detect structural variants and off-target effects from gene editing with sensitivity down to 5% variant allele fractions. It adds to prior OGM data in hematologic malignancies and other areas, reinforcing Bionano’s focus on structural variant detection. Investors may watch for additional publications, adoption in cell and gene therapy workflows, and future financial updates to gauge whether growing technical validation translates into commercial traction.

Key Terms

optical genome mapping, ogm, crispr-cas9, lentiviral transduction, +4 more

8 terms

optical genome mapping medical

"describing the application of optical genome mapping (OGM) to detect genomic alterations"

Optical genome mapping is a laboratory technique that produces a high-resolution picture of a person’s long DNA strands to find large structural changes such as missing, extra, or rearranged pieces. For investors, it matters because the method can improve diagnosis, speed development of genetic tests and therapies, and influence regulatory approvals and market demand for companies offering more accurate or faster genomic tools — think of it as a wide-angle camera that reveals large-scale defects traditional microscopes might miss.

ogm medical

"The results suggest that OGM could be a valuable tool for quality control (QC)"

A genetically modified organism (OGM, from the French acronym) is a plant, animal, or microbe whose genetic makeup has been intentionally altered, like editing the recipe for a crop to give it new traits such as pest resistance or faster growth. Investors care because GMOs can change production costs, market access, legal and regulatory risks, and consumer demand — similar to how a new manufacturing technique can reshape a product’s price, sales, and regulatory hurdles.

crispr-cas9 medical

"including transposons, lentiviral transduction, and CRISPR-Cas9-mediated locus insertion"

A gene‑editing technology that acts like a GPS and scissors for DNA: a small guide sequence directs a cutting protein to a specific spot in a genome so genetic material can be removed, repaired, or replaced. Investors care because CRISPR‑Cas9 underpins many experimental drugs, diagnostics, and crop improvements, meaning it can drive big future revenues but also brings scientific uncertainty, regulatory scrutiny, patent disputes, and long development timelines.

lentiviral transduction medical

"introduced by different gene editing technologies, including transposons, lentiviral transduction"

Lentiviral transduction is a laboratory method that uses engineered lentiviruses to deliver and integrate new genetic material into living cells, effectively giving the cells new instructions much like installing permanent software. For investors, it matters because this technique is a common way to create long-lasting gene and cell therapies; its success, safety and manufacturing complexity can strongly affect a therapy’s therapeutic value, regulatory approval risk and commercial cost.

transposons medical

"introduced by different gene editing technologies, including transposons, lentiviral transduction"

Transposons are sections of DNA that can move or copy themselves to different places within a genome, often called "jumping genes." They matter to investors because their movement can change how genes work—creating disease risks, novel drug targets, or new tools for genetic engineering and diagnostics—so companies that study or use them can affect therapeutic pipelines, regulatory risk, and valuation much like a disruptive technology would in other industries.

structural variants medical

"detect large genomic rearrangements and structural variants (SVs) with sensitivity"

Structural variants are large-scale changes in an organism’s DNA—such as missing, extra, flipped, or rearranged chunks of genetic material—that are like tearing out, duplicating, or reshuffling chapters in a book. Investors should care because these changes can drive or explain diseases, alter how well diagnostics and therapies work, and shift the commercial and regulatory outlook for drugs, tests, and gene-based treatments.

variant allele fractions medical

"structural variants (SVs) with sensitivity to variant allele fractions (VAFs) as low as 5%"

Variant allele fraction is the percentage of DNA molecules in a sample that carry a specific genetic change versus the normal version, measured by sequencing. For investors, this number helps gauge how widespread a mutation is—like counting red marbles in a jar—and can indicate disease burden, treatment response, or how reliable a diagnostic test is, which can affect the commercial value of therapies and diagnostics.

cytogenetics medical

"OGM is increasingly recognized as a powerful alternative to traditional cytogenetics"

Cytogenetics is the study of chromosomes—the structures inside cells that hold genes—and how their number or shape can change. For investors in healthcare and biotech, cytogenetics matters because those chromosomal changes can diagnose diseases, determine which patients will benefit from a therapy, and influence regulatory approval and market size; think of it as a blueprint check that reveals whether a treatment targets the right problem.

AI-generated analysis. Not financial advice.

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
eholmlin@bionano.com

Investor Relations:
Kelly Gura
Gilmartin Group
+1 (212) 229-6163
IR@bionano.com

FAQ

What did BNGO report about OGM sensitivity in the February 4, 2026 study?

OGM showed genome-wide detection sensitivity to variant allele fractions as low as 5%. According to the company, this sensitivity enabled detection of low-frequency structural variants in iPSC lines before and after gene editing workflows used in the study.

How did OGM perform versus traditional cytogenetic and sequencing methods in the BNGO study?

OGM outperformed traditional cytogenetics and sequencing in detecting complex structural variants. According to the company, OGM revealed cryptic rearrangements and copy-number changes that other methods missed in engineered cell lines.

What differences did the study find between CRISPR-Cas9 and transposon/lentiviral editing (BNGO)?

CRISPR-Cas9 resulted in more precise and limited transgene insertion compared with transposons and lentiviral transduction. According to the company, transposons and lentiviral methods produced a higher number of insertions in the genome.

Can OGM be used for quality control of engineered cell lines according to BNGO?

Yes. OGM can be a complementary QC tool to assess genome integrity in engineered cell lines. According to the company, it helps identify structural variants and rearrangements relevant to safety and genetic fidelity.

Does the February 4, 2026 publication say gene editing can cause off-target genomic alterations?

The study indicates editing processes can introduce potentially pathogenic off-target structural alterations. According to the company, OGM revealed previously undetected rearrangements present only in engineered cells, suggesting some edits may escape other assays.