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Bionano Announces Largest OGM Study of T-Cell Acute Lymphoblastic Leukemia

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Bionano (Nasdaq: BNGO) reported a peer-reviewed T-cell acute lymphoblastic leukemia (T-ALL) study in Modern Pathology using optical genome mapping (OGM).

In 91 T-ALL cases, OGM detected abnormalities in 97.8% of samples versus 55% for karyotyping, delivered added genomic insights in ~70%, identified 45 gene fusions (24 known, 21 novel), and supported refined T-ALL subtype classification in a single workflow.

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AI-generated analysis. Not financial advice.

Positive

  • Largest OGM T-ALL study with 91 cases analyzed across three platforms
  • OGM detected abnormalities in 97.8% of T-ALL cases vs 55% by karyotyping
  • OGM provided additional genomic insights in approximately 70% of T-ALL cases
  • Identified 24 known and 21 novel T-ALL gene fusions
  • Copy number changes detected in 93% of cases using OGM
  • Study supports OGM plus NGS as complementary for T-ALL genomics

Negative

  • None.

News Market Reaction – BNGO

-1.61%
1 alert
-1.61% News Effect
-$229K Valuation Impact
$14.00M Market Cap
0.0x Rel. Volume

On the day this news was published, BNGO declined 1.61%, reflecting a mild negative market reaction. This price movement removed approximately $229K from the company's valuation, bringing the market cap to $14.00M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

OGM detection rate: 97.8% Karyotyping detection rate: 55% Study size: 91 cases +5 more
8 metrics
OGM detection rate 97.8% T-ALL genomic abnormalities detected by optical genome mapping
Karyotyping detection rate 55% T-ALL abnormalities detected by conventional karyotyping
Study size 91 cases T-ALL cases analyzed across OGM, karyotyping, and NGS
Additional insights rate 70% Cases where OGM provided added genomic information beyond standard methods
Gene rearrangement rate 80% T-ALL cases with gene rearrangements detected by OGM
Copy number changes 93% Cases where OGM identified copy number changes
Sequence variants (NGS) 92% Cases where NGS detected sequence variants
NOTCH1 variants 57% T-ALL cases with NOTCH1 gene variants

Market Reality Check

Price: $1.2450 Vol: Volume at 210,506 is abou...
normal vol
$1.2450 Last Close
Volume Volume at 210,506 is about 1.28x the 20-day average of 163,893. normal
Technical Price $1.24 is trading below the $1.76 200-day MA and 77.45% under the 52-week high.

Peers on Argus

Sector peers showed mixed moves, with FEMY up 9.59% and MLSS down 3.52%, suggest...
1 Up 1 Down

Sector peers showed mixed moves, with FEMY up 9.59% and MLSS down 3.52%, suggesting today’s action was more stock-specific than sector-driven.

Historical Context

5 past events · Latest: May 13 (Negative)
Pattern 5 events
Date Event Sentiment Move Catalyst
May 13 Q1 2026 earnings Negative -4.8% Q1 revenue growth with higher margins but a wider loss and cautious outlook.
May 06 Leadership change Negative +4.7% CEO removal and appointment of interim CEO and new lead independent director.
May 05 OGM rare disease data Positive +0.0% Report of 28 OGM publications in rare disease, up ~56% year over year.
Apr 29 Earnings call announcement Neutral +0.0% Scheduling of Q1 2026 earnings release and webcast details.
Apr 02 OGM myeloma study Positive +0.8% Multicenter study showing OGM outperforming traditional methods in multiple myeloma.
Pattern Detected

OGM-related publications have generally seen small or positive reactions, while earnings and leadership changes have produced sharper, but mixed, moves.

Recent Company History

Over the last two months, Bionano reported Q1 2026 results with $6.7M revenue and a negative price reaction, while a leadership transition on May 6 drew a positive move. Multiple news items highlighted growing validation of OGM, including a Modern Pathology multiple myeloma study analyzing 211 samples and a rare-disease update citing 28 publications and a ~56% increase year over year. Today’s T-ALL study adds another peer-reviewed data point reinforcing OGM’s performance in hematologic cancers.

Regulatory & Risk Context

Active S-3 Shelf · $400,000,000
Shelf Active
Active S-3 Shelf Registration 2026-05-08
$400,000,000 registered capacity

An effective S-3 shelf filed on May 8, 2026 allows the company to offer up to $400,000,000 of securities for general corporate purposes, with no usage yet recorded and specific terms to be set by future prospectus supplements.

Market Pulse Summary

This announcement highlights peer-reviewed evidence that OGM detected abnormalities in 97.8% of T-AL...
Analysis

This announcement highlights peer-reviewed evidence that OGM detected abnormalities in 97.8% of T-ALL cases versus 55% for karyotyping, reinforcing Bionano’s positioning in complex blood cancers. It follows prior publications in multiple myeloma and rare diseases, building a consistent technical story. At a share price of $1.24, far below the $5.50 52-week high, investors may watch how such clinical validation translates into revenue growth and how the unused $400M shelf is ultimately deployed.

Key Terms

optical genome mapping, t-cell acute lymphoblastic leukemia, karyotyping, next-generation sequencing, +4 more
8 terms
optical genome mapping medical
"showing that optical genome mapping (OGM) detected genomic abnormalities in 97.8%"
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.
t-cell acute lymphoblastic leukemia medical
"detected genomic abnormalities in 97.8% of T-cell acute lymphoblastic leukemia (T-ALL) cases"
A fast-growing blood cancer in which immature T‑cells — a type of white blood cell that normally fights infection — multiply abnormally and crowd out healthy blood cells. For investors, it matters because it defines a specific patient group, treatment needs, and regulatory pathway: successful drugs or tests for this disease can command premium pricing and rapid approval, while failures can sharply affect biotech valuations, much like a single key product can make or break a company.
karyotyping medical
"The 91-subject study compared OGM head-to-head against conventional karyotyping and next-generation sequencing"
Karyotyping is a laboratory test that takes a picture of an organism’s chromosomes—the structures that carry genes—to look for missing, extra, or rearranged pieces. For investors, karyotyping matters because those chromosome findings can affect the development, safety, regulatory approval, and market prospects of medical products or diagnostics; think of it like proofreading a book to spot missing or shuffled chapters that could change the story.
next-generation sequencing medical
"compared OGM head-to-head against conventional karyotyping and next-generation sequencing (NGS)"
Next-generation sequencing is a set of laboratory techniques that read large amounts of DNA or RNA quickly and cheaply by processing millions of short genetic fragments in parallel, rather than one at a time. For investors, it matters because faster, lower-cost genetic data powers drug discovery, diagnostic tests and personalized medicine, creating scalable revenue opportunities and competitive advantages for companies that own the technology or services.
copy number medical
"Comprehensive sequence variant and copy number profiling: OGM identified copy number changes in 93% of cases"
Number of copies refers to how many copies of a particular gene or stretch of DNA are present in a cell’s genome. Like counting photocopies of a specific page in a multi-page document, extra or missing copies can change how cells behave, so investors watch copy number because it can influence disease risk, patient response to therapies, use as a diagnostic marker, and the commercial prospects of biotech and diagnostics products.
gene fusions medical
"24 known + 21 novel gene fusions identified: OGM detected gene rearrangements in 80% of cases"
A gene fusion is what happens when parts of two different genes become joined together, creating a single, new genetic instruction that can make an abnormal protein. For investors, gene fusions matter because they can drive disease in predictable ways and serve as clear targets for diagnostics and drugs—like finding a unique fingerprint that lets a company build a precise test or a tailored therapy, which can affect clinical success and commercial value.
structural variant analysis medical
"reinforces why comprehensive structural variant analysis matters in blood cancer research"
Structural variant analysis is the process of finding and interpreting large-scale changes in an organism's DNA—such as missing sections, extra copies, flipped pieces, or pieces that moved to a new location. Think of it like checking a book for torn pages, duplicated chapters, or paragraphs stuck in the wrong place; these changes can dramatically alter how genes work. For investors, this analysis matters because it underpins genetic diagnostics, drug target identification, and the commercial value of therapies and tests that rely on accurate detection of these big DNA changes.
cytogenetic medical
"showing that optical genome mapping (OGM) can outperform traditional cytogenetic methods in multiple myeloma"
Relating to the study of cells’ chromosomes — the bundled packages of DNA that act like a building’s blueprint for traits and behavior. Cytogenetic information shows whether those blueprints have missing, extra, or rearranged pieces, which can affect disease diagnosis, how patients respond to treatments, and whether a therapy is safe; for investors, that data can influence clinical trial outcomes, regulatory approval chances, and market potential.

AI-generated analysis. Not financial advice.

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SAN DIEGO, May 26, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced publication of a peer-reviewed study in Modern Pathology showing that optical genome mapping (OGM) detected genomic abnormalities in 97.8% of T-cell acute lymphoblastic leukemia (T-ALL) cases — nearly double the 55% detection rate achieved by conventional cytogenetic analysis. Conducted by researchers at The University of Texas MD Anderson Cancer Center and Johns Hopkins University School of Medicine and representing one of the most comprehensive genomic analyses of T-ALL to date, the study underscores OGM’s potential to transform how this aggressive blood cancer is studied and understood.

T-ALL is an aggressive form of pediatric and adult leukemia driven by a wide variety of complex genetic changes, many of which are too subtle or structurally complex to be detected by traditional methods. The disease is notoriously difficult to characterize fully, limiting the ability of researchers to study its biology, classify subtypes, and develop targeted therapies.

The 91-subject study compared OGM head-to-head against conventional karyotyping and next-generation sequencing (NGS) — the standard tools for evaluating T-ALL. Where karyotyping identified abnormalities in just 55% of cases, OGM found them in 97.8% of cases, and provided additional genomic insights beyond standard methods in approximately 70% of the cases — all from OGM’s single workflow.

Key Highlights:

  • 91 cases: of T-ALL cases analyzed across three platforms — OGM, conventional karyotyping, and NGS — making this study the largest OGM study of T-ALL conducted to date.
  • High success rate for finding abnormalities: OGM identified chromosomal abnormalities in 97.8% of cases, compared to 55% by conventional karyotyping — a dramatic improvement in detection for a disease where missed findings can leave the biology incompletely understood.
  • Broader picture in 70% of cases: OGM delivered clinically relevant genomic information beyond karyotyping in approximately 70% of cases, uncovering abnormalities that standard methods missed — all without requiring additional testing.
  • 24 known + 21 novel gene fusions identified: OGM detected gene rearrangements in 80% of cases, including 24 known recurrent fusions and 21 newly identified fusions, pointing to potential new targets for T-ALL research.
  • Comprehensive sequence variant and copy number profiling: OGM identified copy number changes in 93% of cases. NGS detected sequence variants in 92% of cases. The gene most frequently found to harbor variants was NOTCH1 (57% of cases).
  • Disease subtypes decoded: OGM uncovered distinct genomic patterns across T-ALL subtypes, supporting more precise biological classification of this heterogeneous disease.
  • OGM can streamline workflows for T-ALL. T-ALL presents particular challenges for standard genomic analysis: samples often yield poor-quality material for karyotyping, and many of the most biologically important genetic changes are subtle, small-scale, or driven by rearrangements in non-coding regions of the genome. Conventional approaches typically require multiple sequential analyses to piece together a complete picture — a process that is time-consuming, costly, and incomplete. OGM can address these limitations with a genome-wide approach that captures the full landscape of genetic variation in a single workflow.

“This publication further strengthens the growing body of evidence supporting OGM as a powerful tool for resolving the genomic complexity of challenging childhood and adult blood cancers like T-ALL, 50% of which remain unsolved by legacy methods, such as, karyotyping. This study, as one of the first and largest of its kind in T-ALL, demonstrates the complementarity that OGM and NGS can provide and shows how OGM can be particularly well-suited to T-ALL’s unique challenges — including poor sample quality, subtle rearrangements, and a wide range of genomic targets — capturing recurrent and novel alterations in a single pass that would otherwise require multiple sequential tests,” said Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. Dr. Chaubey continued, “the ability to uncover subtle and complex rearrangements in diseases like T-ALL can give researchers a far more complete picture of the biology — and reinforces why comprehensive structural variant analysis matters in blood cancer research.”

The full publication, Comprehensive Cytogenomic Profiling of T-Lymphoblastic Leukemia Using Optical Genome Mapping, Karyotyping, and Next-Generation Sequencing, is available in Modern Pathology at: https://www.modernpathology.org/article/S0893-3952(26)00029-3/

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, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. Words such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “support,” “target,” “will,” or “would” 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 substantially improve detection of relevant cytogenomic abnormalities in T-ALL compared with conventional karyotyping; the ability and utility of OGM to transform how this aggressive blood cancer is studied and understood; the ability and utility of OGM to provide critical genomic information that complements NGS; the ability and utility of OGM to streamline workflows and address limitations of standard genomic analysis with a genome-wide approach that captures the full landscape of genetic variation in a single workflow; the ability of OGM to outperform legacy cytogenomic methods; continued research, presentations and publications involving OGM, its utility compared to traditional cytogenetics and our technologies; our ability to drive adoption of OGM and our technology solutions; 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 substantially improve detection of relevant cytogenomic abnormalities in T-ALL compared with conventional karyotyping; the failure of OGM to transform how this aggressive blood cancer is studied and understood; the failure of OGM to provide critical genomic information that complements NGS; the failure of OGM to streamline workflows and address limitations of standard genomic analysis with a genome-wide approach that captures the full landscape of genetic variation in a single workflow; the failure of OGM to outperform legacy cytogenomic methods; 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, such as the ongoing international conflicts 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; 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, 2025, 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:
Webb Campbell
Gilmartin Group
+1 (415) 520-5817
IR@bionano.com


FAQ

What did Bionano (BNGO) announce about the T-ALL study on May 26, 2026?

Bionano announced a peer-reviewed T-cell acute lymphoblastic leukemia study showing high optical genome mapping detection rates. According to Bionano, the 91-case study in Modern Pathology found OGM abnormalities in 97.8% of T-ALL cases, substantially exceeding conventional karyotyping performance.

How does optical genome mapping performance in T-ALL compare with karyotyping in the BNGO study?

Optical genome mapping detected genomic abnormalities in 97.8% of T-ALL cases, versus 55% for karyotyping. According to Bionano, this higher detection allowed OGM to deliver additional clinically relevant genomic information beyond karyotyping in approximately 70% of cases using a single workflow.

How many T-ALL cases and gene fusions were analyzed in Bionano's OGM study (BNGO)?

The study analyzed 91 T-ALL cases and identified 45 gene fusions using OGM. According to Bionano, OGM detected gene rearrangements in 80% of cases, including 24 known recurrent fusions and 21 novel fusions, suggesting potential new avenues for T-ALL research.

What did the BNGO T-ALL study reveal about copy number changes and sequence variants?

The study reported high rates of copy number changes and sequence variants in T-ALL samples. According to Bionano, OGM identified copy number changes in 93% of cases, while NGS detected sequence variants in 92%, with NOTCH1 variants present in 57% of cases.

How might Bionano's OGM streamline genomic workflows for T-ALL research?

OGM may streamline T-ALL genomic assessment by consolidating multiple tests into one workflow. According to Bionano, OGM captures genome-wide structural variation, uncovers subtle and complex rearrangements, and provides additional clinically relevant information in about 70% of cases without extra testing.

What is the relationship between OGM and NGS in Bionano's T-ALL study?

The study suggests that OGM and NGS offer complementary insights into T-ALL genomics. According to Bionano, OGM excels at structural variants and copy number changes, while NGS detects sequence variants, together providing a more complete picture of T-ALL biology and subtype classification.