Bionano Announces Publication Showing OGM Can Overcome Key Limitations of Targeted RNA-Seq for Cytogenetic Investigation in Acute Leukemia
Bionano (Nasdaq: BNGO) announced a peer-reviewed MD Anderson study published in Cancers showing optical genome mapping (OGM) can overcome key limitations of targeted RNA-seq for detecting gene rearrangements in acute leukemia.
In a cohort of 467 subjects, 234 gene rearrangements/fusions were detected across 206 subjects (43.6%). OGM and RNA-seq both detected 175 events (74.7% of positives); OGM uniquely found 37 events (15.8%) and RNA-seq uniquely found 22 (9.4%). Tier 1 aberrations appeared in 147 subjects (31.5%). RNA-seq detected only 20.6% of enhancer-hijacking events found by OGM. The study concludes OGM plus RNA-seq yields the most comprehensive genomic profiling in acute leukemia.
Bionano (Nasdaq: BNGO) ha annunciato uno studio peer-reviewed di MD Anderson pubblicato su Cancers che mostra l'optical genome mapping (OGM) può superare le principali limitazioni del RNA-seq mirato per rilevare riarrangiamenti genetici nella leucemia acuta.
In una coorte di 467 soggetti, sono stati rilevati 234 riarrangiamenti/fusioni genetiche in 206 soggetti (43,6%). OGM e RNA-seq hanno entrambi rilevato 175 eventi (74,7% dei positivi); OGM ha trovato in modo univoco 37 eventi (15,8%) e RNA-seq 22 (9,4%). Le aberrazioni di livello 1 apparivano in 147 soggetti (31,5%). RNA-seq ha rilevato solo 20,6% degli eventi di hijacking degli enhancer trovati da OGM. Lo studio conclude che OGM più RNA-seq offrono la profilazione genomica più completa nella leucemia acuta.
Bionano (Nasdaq: BNGO) anunció un estudio revisado por pares de MD Anderson publicado en Cancers que muestra que el mapeo del genoma óptico (OGM) puede superar las limitaciones clave del RNA-seq dirigido para detectar reordenamientos genéticos en la leucemia aguda.
En una cohorte de 467 sujetos, se detectaron 234 reordenamientos/fusiones en 206 sujetos (43,6%). OGM y RNA-seq detectaron ambos 175 eventos (74,7% de los positivos); OGM encontró de forma única 37 eventos (15,8%) y RNA-seq 22 (9,4%). Las aberraciones de Nivel 1 aparecieron en 147 sujetos (31,5%). RNA-seq detectó solo 20,6% de los eventos de secuestro de enhancers encontrados por OGM. El estudio concluye que OGM más RNA-seq ofrecen el perfil genómico más completo en leucemia aguda.
바이오나노(Bionano, 나스닥: BNGO)가 MD 앤더슨(MD Anderson)의 동료 평가 연구를 Cancers에 발표했다. 이 연구는 광학 유전체 매핑(O G M, optical genome mapping)이 표적 RNA-seq가 급성 백혈병에서 유전자 재배열을 탐지하는 데 있어 주요 한계를 극복할 수 있음을 보여준다.
총 467명의 피험자 중 234건의 유전자 재배열/융합이 206명에서 검출되어(43.6%) 발견되었다. OGM과 RNA-seq는 각각 175건의 이벤트를 검출했으며(양성의 74.7%), OGM은 고유하게 37건(15.8%)를, RNA-seq는 22건(9.4%)를 발견했다. 1급 이상 이상은 147명(31.5%)에게 나타났다. RNA-seq는 OGM이 발견한 증강인자 해킹(enhancer hijacking) 이벤트의 20.6%만 검출했다. 이 연구는 OGM과 RNA-seq를 함께 사용하면 급성 백혈병에서 가장 포괄적인 유전체 프로파일링을 제공한다고 결론지었다.
Bionano (Nasdaq: BNGO) a annoncé une étude évaluée par des pairs du MD Anderson, publiée dans Cancers, montrant que l'optical genome mapping (OGM) peut surmonter les principales limitations du RNA-seq ciblé pour détecter des réarrangements génétiques dans la leucémie aiguë.
Dans une cohorte de 467 sujets, on a détecté 234 réarrangements/fusions dans 206 sujets (43,6%). L'OGM et le RNA-seq ont tous deux détecté 175 événements (74,7% des positifs); l'OGM a trouvé iniquement 37 événements (15,8%) et le RNA-seq 22 (9,4%). Les aberrations de niveau 1 apparaissaient chez 147 sujets (31,5%). Le RNA-seq n'a détecté que 20,6% des événements de détournement d'enhancer trouvés par l'OGM. L'étude conclut que l'association OGM + RNA-seq offre le profilage génomique le plus complet dans la leucémie aiguë.
Bionano (Nasdaq: BNGO) kündigte eine begutachtete Studie des MD Anderson an, die in Cancers veröffentlicht wurde und zeigt, dass optical genome mapping (OGM) die wichtigsten Einschränkungen des zielgerichteten RNA-seq bei der Erkennung von Genom-Rearrangements in der akuten Leukämie überwinden kann.
In einer Kohorte von 467 Probanden wurden 234 Genom-Rearrangements/Fusionen bei 206 Probanden (43,6%) nachgewiesen. OGM und RNA-seq identifizierten beide 175 Ereignisse (74,7% der Positiven); OGM fand eindeutig 37 Ereignisse (15,8%) und RNA-seq 22 (9,4%). Tier-1-Aberrationen traten bei 147 Probanden (31,5%) auf. RNA-seq erkannte nur 20,6% der Enhancer-Hijacking-Ereignisse, die von OGM gefunden wurden. Die Studie kommt zu dem Schluss, dass OGM plus RNA-seq das umfassendste genomische Profiling in der akuten Leukämie liefert.
بايونانو (بورصة ناسداك: BNGO) أعلنت عن دراسة مُراجَعة من قِبَل أقرانها في مركز MD أندرسون نُشرت في Cancers تُظهر أن رسم خرائط الجينوم البصرية (OGM) يمكنه أن يتجاوز القيود الرئيسية لـ RNA-seq المستهدف لاكتشاف إعادة ترتيب الجينات في اللوكيميا الحادة.
في عينة من 467 مشاركًا، تم اكتشاف 234 إعادة ترتيب/اندماج جيني عبر 206 مشاركًا (43.6%). اكتشف OGM وRNA-seq معًا 175 حدثًا (74.7% من الإيجابيات)؛ وجدت OGM فريدًا 37 حدثًا (15.8%) وRNA-seq 22 (9.4%). ظهرت تشوّهات المستوى 1 لدى 147 مشاركًا (31.5%). اكتشف RNA-seq فقط 20.6% من أحداث اختطاف المنّشّطات المعزّزة التي وجدتها OGM. تخلص الدراسة إلى أن الجمع بين OGM وRNA-seq يوفر أولاً profiling جيني أكثر شمولاً في اللوكيميا الحادة.
- OGM uniquely detected 37 events (15.8%)
- Both methods detected 175 events (74.7% of positives)
- Tier 1 aberrations found in 147 subjects (31.5%)
- Combined testing offers most comprehensive profiling
- RNA-seq missed many enhancer-hijacking events; detected 20.6%
- RNA-seq unique detections were limited to 22 events (9.4%)
- RNA-seq can yield false-negatives when fusion transcripts are absent
Insights
Peer-reviewed data show Bionano optical genome mapping finds more clinically relevant structural variants than a 108-gene targeted RNA-seq panel.
Business mechanism: The study compares OGM (DNA-level structural variant detection) with a targeted RNA-seq panel across 467 acute leukemia subjects and reports that OGM identified a higher share of clinically relevant SVs. Combined testing would capture the broadest set of events because RNA-seq finds expressed chimeric transcripts while OGM detects cryptic rearrangements, enhancer-hijackings, and large-scale events that RNA-seq can miss.
Dependencies and risks: The conclusion rests on a single cohort and a specific 108-gene panel; outcomes may vary with different RNA panels, sample quality, or lab workflows. The study reports that
Concrete items to watch: peer adoption of combined OGM+RNA workflows, guideline or society citations of OGM findings, and follow-up validation studies or clinical diagnostic implementations in the next 6–24 months; the paper was published on
SAN DIEGO, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of a study in Cancers from The University of Texas MD Anderson Cancer Center showing how optical genome mapping (OGM) can address key limitations of targeted RNA-sequencing (RNA-seq) panels in detecting therapeutically-relevant gene rearrangements in acute leukemias. This peer-reviewed publication, entitled “Comparative Analysis of Targeted RNA-Seq and Optical Genome Mapping for Detecting Gene Rearrangements in Acute Leukemia,” is the first to describe the comparison of OGM and RNA-seq in cancer.
While RNA-seq panels are useful for detecting expressed variants, including chimeric transcripts, they have limitations. For example, when rearrangements lead to overexpression of a gene under a hijacked enhancer or when fusion transcripts are absent or poorly expressed, RNA-seq analysis may yield false-negative results. OGM complements RNA-seq with its ability to detect structural variants (SVs) at the DNA level that RNA-seq may fail to detect, including cryptic rearrangements, fusion genes, enhancer-hijackings, and large‐scale events more commonly identified with legacy cytogenetic techniques.
Summary of Key Findings
- A total of 234 gene rearrangements or fusions were detected by OGM and/or RNA-seq across 206 subjects (
43.6% ) in a cohort of 467 acute leukemia research subjects. This rate varied across different leukemia types, from36.1% in acute myelogenous leukemia (AML) to75% in T-cell acute lymphoblastic leukemia (T-ALL) - 175 of the 234 gene rearrangements or fusions (
74.7% ) were detected by both OGM and the targeted RNA-seq panel - OGM uniquely identified 37 events (
15.8% ) of varying complexity, whereas the RNA-seq panel uniquely identified 22 events (9.4% ), mostly small gene insertions and intrachromosomal deletions - Tier 1 aberrations, which are classified as those having well-established prognostic, diagnostic, or therapeutic relevance according to guidelines set by medical societies such as WHO, NCCN and ICC, were found by OGM and/or RNA-seq in 147 of the 467 subjects (
31.5% ) - RNA-seq detected just
20.6% of the enhancer-hijacking events detected by OGM. Gene rearrangements or fusions in this class, such as MECOM, BCL11B and IGH rearrangements, can be important to reliably detect since they are known to be drivers of leukemogenesis
Overall, this study from The University of Texas MD Anderson Cancer Center showed that OGM can identify a higher proportion of clinically significant SVs compared to a 108-gene targeted RNA-seq panel. Using OGM and RNA-seq together on the same cohort would yield the most comprehensive result in acute leukemia cases.
“This study is a great representation of how the utility of OGM is continuing to expand,” said Erik Holmlin, PhD, president and CEO of Bionano. “With this comparison against RNA-seq, we believe OGM is growing its footprint in digital pathology where it is imperative to use tools that reveal the complete architecture of the cancer genome and capture cryptic events that other technologies miss. The combination of OGM and RNA-seq can deliver the most comprehensive analysis of genome to potentially impact disease classification, risk stratification, and therapeutic selection.”
The full research publication, Comparative Analysis of Targeted RNA-Seq and Optical Genome Mapping for Detecting Gene Rearrangements in Acute Leukemia, is available at: https://www.mdpi.com/2072-6694/17/21/3458.
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 “ability,” “believe,” “can,” “may,” “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, current expectations, or future expectations concerning, among other things; the ability and utility of OGM to address key limitations of RNA-seq panels in detecting therapeutically-relevant gene rearrangements in acute leukemias; the ability and utility of OGM to detect SVs at the DNA level that RNA-seq may fail to detect; the ability and utility of OGM to identify a higher proportion of clinically significant SVs compared to what a 108-gene targeted RNA-seq panel can identify; the ability and utility of using OGM and RNA-seq together on the same cohort to yield the most comprehensive result in acute leukemia cases; whether OGM is growing its footprint in digital pathology; the ability and utility of combining OGM with RNA-seq to deliver the most comprehensive analysis of genome to potentially impact disease classification, risk stratification and therapeutic selection;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 address key limitations of RNA-seq panels in detecting therapeutically-relevant gene rearrangements in acute leukemias; the failure of OGM to detect SVs at the DNA level that RNA-seq may fail to detect; the failure of OGM to identify a higher proportion of clinically significant SVs compared to what a 108-gene targeted RNA-seq panel can identify; the failure of OGM and RNA-seq used together on the same cohort to yield the most comprehensive result in acute leukemia cases; the failure of OGM to growing its footprint in digital pathology; the failure of a combined OGM with RNA-seq to deliver the most comprehensive analysis of genome to potentially impact disease classification, risk stratification and therapeutic selection; the failure of OGM be useful in the applications described in the publications referenced in this press release; future publications that differ or contradict the findings of the publication referenced in this press release; our ability to obtain sufficient financing to fund our business 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 business 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 conflicts between Ukraine and Russia and in the Middle East 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; 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 announce about OGM in acute leukemia on November 6, 2025?
How many acute leukemia subjects were analyzed in the BNGO-linked study?
How many gene rearrangements did OGM and RNA-seq detect in the study?
What proportion of events did both OGM and targeted RNA-seq detect in the BNGO study?
How often did OGM uniquely identify events compared with the RNA-seq panel?
What clinical relevance did the study report about Tier 1 aberrations?
Why might RNA-seq give false-negatives according to the November 6, 2025 announcement?
