Bionano Announces Publication Reporting First Use of OGM to Detect Chromoanagenesis, a Key Marker of Poor Prognosis in AML
Bionano Genomics (BNGO) has announced groundbreaking research published in the American Journal of Hematology showcasing the first-ever use of optical genome mapping (OGM) to detect chromoanagenesis (CAG) in acute myeloid leukemia (AML).
The study, led by Dr. Guilin Tang at MD Anderson Cancer Center, analyzed 410 AML cases and revealed that CAG was present in 16% of cases, with notably higher occurrence in high-risk cytogenetic profiles. Key findings showed that patients with CAG had:
- Only 5 months median survival vs 14 months without CAG
- Strong correlation with complex karyotypes (92%)
- High association with TP53 mutations (92%)
- Significantly lower response to combination therapy
The research suggests OGM may be more sensitive than traditional cytogenetic methods in identifying aggressive forms of AML, potentially enabling earlier appropriate therapy intervention for patients.
Bionano Genomics (BNGO) ha annunciato una ricerca innovativa pubblicata nell'American Journal of Hematology che mostra il primo utilizzo di mappatura genomica ottica (OGM) per rilevare la cromoanagenesi (CAG) nella leucemia mieloide acuta (AML).
Lo studio, guidato dal Dr. Guilin Tang presso il MD Anderson Cancer Center, ha analizzato 410 casi di AML e ha rivelato che la CAG era presente nel 16% dei casi, con una frequenza notevolmente più alta nei profili citogenetici ad alto rischio. I risultati chiave hanno mostrato che i pazienti con CAG avevano:
- Solo 5 mesi di sopravvivenza mediana rispetto a 14 mesi senza CAG
- Una forte correlazione con cariotipi complessi (92%)
- Un'alta associazione con mutazioni di TP53 (92%)
- Una risposta significativamente inferiore alla terapia combinata
La ricerca suggerisce che l'OGM potrebbe essere più sensibile rispetto ai metodi citogenetici tradizionali nell'identificare forme aggressive di AML, consentendo potenzialmente un intervento terapeutico appropriato più precoce per i pazienti.
Bionano Genomics (BNGO) ha anunciado una investigación innovadora publicada en el American Journal of Hematology que muestra el primer uso de mapeo genómico óptico (OGM) para detectar la cromoanagénesis (CAG) en leucemia mieloide aguda (AML).
El estudio, dirigido por el Dr. Guilin Tang en el MD Anderson Cancer Center, analizó 410 casos de AML y reveló que la CAG estaba presente en el 16% de los casos, con una ocurrencia notablemente más alta en perfiles citogenéticos de alto riesgo. Los hallazgos clave mostraron que los pacientes con CAG tenían:
- Solo 5 meses de supervivencia media frente a 14 meses sin CAG
- Una fuerte correlación con cariotipos complejos (92%)
- Una alta asociación con mutaciones de TP53 (92%)
- Una respuesta significativamente menor a la terapia combinada
La investigación sugiere que el OGM puede ser más sensible que los métodos citogenéticos tradicionales para identificar formas agresivas de AML, lo que podría permitir una intervención terapéutica apropiada más temprana para los pacientes.
Bionano Genomics (BNGO)는 미국 혈액학 저널(American Journal of Hematology)에 발표된 혁신적인 연구 결과를 발표하였으며, 이는 급성 골수성 백혈병(AML)에서 크로모아나제네시스(CAG)를 탐지하기 위해 광학 유전체 매핑(OGM)을 최초로 사용한 사례입니다.
MD 앤더슨 암 센터의 Guilin Tang 박사가 이끄는 이 연구는 410개의 AML 사례를 분석하였으며, CAG가 16%의 사례에서 발견되었고, 특히 고위험 세포유전학적 프로파일에서 더 높은 발생률을 보였습니다. 주요 발견은 CAG가 있는 환자들이:
- CAG가 없는 경우에 비해 중위 생존 기간이 14개월인 반면, 단지 5개월
- 복잡한 핵형과의 강한 상관관계 (92%)
- TP53 변이와의 높은 연관성 (92%)
- 복합 요법에 대한 반응이 유의미하게 낮음
이 연구는 OGM이 공격적인 AML 형태를 식별하는 데 전통적인 세포유전학적 방법보다 더 민감할 수 있음을 시사하며, 이는 환자에게 보다 조기 적절한 치료 개입을 가능하게 할 수 있습니다.
Bionano Genomics (BNGO) a annoncé des recherches révolutionnaires publiées dans l'American Journal of Hematology, mettant en avant la première utilisation de cartographie génomique optique (OGM) pour détecter la chromoanagenèse (CAG) dans la leucémie myéloïde aiguë (AML).
L'étude, dirigée par le Dr. Guilin Tang au MD Anderson Cancer Center, a analysé 410 cas d'AML et a révélé que la CAG était présente dans 16% des cas, avec une occurrence nettement plus élevée dans les profils cytogénétiques à haut risque. Les résultats clés ont montré que les patients avec CAG avaient :
- Seulement 5 mois de survie médiane contre 14 mois sans CAG
- Une forte corrélation avec des caryotypes complexes (92%)
- Une forte association avec des mutations de TP53 (92%)
- Une réponse significativement plus faible à la thérapie combinée
La recherche suggère que l'OGM pourrait être plus sensible que les méthodes cytogénétiques traditionnelles pour identifier des formes agressives d'AML, permettant ainsi une intervention thérapeutique appropriée plus précoce pour les patients.
Bionano Genomics (BNGO) hat bahnbrechende Forschung veröffentlicht, die im American Journal of Hematology erscheint und die erstmalige Verwendung von optischer Genomkartierung (OGM) zur Erkennung von Chromoanagenese (CAG) bei akuter myeloischer Leukämie (AML) zeigt.
Die Studie, geleitet von Dr. Guilin Tang am MD Anderson Cancer Center, analysierte 410 AML-Fälle und zeigte, dass CAG in 16% der Fälle vorhanden war, mit bemerkenswert höheren Vorkommen in hochriskanten zytogenetischen Profilen. Wichtige Ergebnisse zeigten, dass Patienten mit CAG:
- Nur 5 Monate mediane Überlebenszeit im Vergleich zu 14 Monaten ohne CAG hatten
- Eine starke Korrelation mit komplexen Karyotypen (92%) aufwiesen
- Eine hohe Assoziation mit TP53-Mutationen (92%) hatten
- Eine signifikant geringere Reaktion auf die Kombinationstherapie zeigten
Die Forschung legt nahe, dass OGM empfindlicher sein könnte als traditionelle zytogenetische Methoden zur Identifizierung aggressiver Formen von AML, was möglicherweise eine frühere angemessene Therapieintervention für Patienten ermöglicht.
- First-ever demonstration of OGM technology detecting chromoanagenesis in AML
- OGM shows higher sensitivity than traditional methods in identifying aggressive AML forms
- Study validates OGM's potential for improving AML risk stratification and treatment planning
- None.
Insights
Bionano's publication on Optical Genome Mapping (OGM) for detecting chromoanagenesis (CAG) in acute myeloid leukemia (AML) represents a significant clinical validation for their diagnostic technology platform. The study from MD Anderson Cancer Center demonstrates OGM's potential superior sensitivity compared to traditional cytogenetic methods in identifying aggressive forms of AML.
The research findings are particularly notable for revealing CAG in
From a commercial perspective, these findings position Bionano's OGM technology to potentially capture market share in the hematologic malignancy testing space, where precise risk stratification directly impacts treatment decisions. The CEO's statement about OGM providing "incremental value" beyond standard cytogenetic methods signals the company's strategic focus on demonstrating clinical utility that exceeds current diagnostic standards.
While immediate revenue impact isn't quantified, this publication represents the kind of evidence-based validation needed to drive clinical adoption of novel diagnostic platforms. The planned educational webinar with the study's lead author indicates Bionano's commitment to promoting these findings to potential clinical users, a critical step in the commercialization pathway for diagnostic technologies.
This study marks a meaningful advancement in AML diagnostics by demonstrating OGM's capability to detect chromoanagenesis (CAG) - a catastrophic genomic event with profound clinical implications. The cohort size of 410 AML cases provides robust statistical power for the findings.
The correlation between CAG and known high-risk features is striking:
The survival differential is compelling: patients with CAG-positive AML had a median survival of only 5 months compared to 14 months for CAG-negative patients - a
What's particularly valuable about this approach is its potential to identify high-risk patients earlier in their disease course. Current cytogenetic analysis can miss these catastrophic events, potentially leading to suboptimal treatment selection. By accurately identifying CAG-positive patients, clinicians could more appropriately escalate to intensive therapies or novel agents rather than standard approaches with efficacy in this subgroup.
The timing is significant as AML treatment has evolved from a one-size-fits-all approach to increasingly personalized regimens based on molecular and cytogenetic profiles. Technologies that further refine risk stratification address a genuine unmet need in clinical hematology-oncology practice, potentially improving resource allocation and patient outcomes.
- 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
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 (
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
FAQ
What are the survival rates for AML patients with chromoanagenesis according to BNGO's study?
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What correlation did BNGO's research find between chromoanagenesis and TP53 mutations in AML?
How does chromoanagenesis affect treatment response according to BNGO's new study?
