Bionano Announces Publication Showing Utility of Optical Genome Mapping in Clinical Research of Infant & Toddler T-ALL
Bionano Genomics (NASDAQ:BNGO) announced a significant peer-reviewed publication demonstrating the effectiveness of their optical genome mapping (OGM) technology in detecting oncogenic structural variants in infant and toddler T-cell acute lymphoblastic leukemia (T-ALL).
The study, conducted across multiple French pediatric centers, analyzed 27 T-ALL cases in children under 3 years. Key findings include: 33% of cases carried previously uncharacterized NKX2 gene rearrangements, distinct genomic profiles compared to older children, and a 75.4% five-year overall survival rate. The research demonstrated OGM's ability to identify prognostic subgroups and detect complex genetic rearrangements in a single workflow, potentially improving disease classification and management.
Bionano Genomics (NASDAQ:BNGO) ha annunciato una pubblicazione peer-reviewed significativa che dimostra l'efficacia della loro tecnologia di mappatura ottica del genoma (OGM) nell'individuare varianti strutturali oncogeniche nella leucemia linfoblastica acuta T (T-ALL) in neonati e bambini piccoli.
Lo studio, condotto in diversi centri pediatrici francesi, ha analizzato 27 casi di T-ALL in bambini sotto i 3 anni. I risultati principali includono: il 33% dei casi presentava riarrangiamenti del gene NKX2 precedentemente non caratterizzati, profili genomici distinti rispetto ai bambini più grandi e un tasso di sopravvivenza globale a cinque anni del 75,4%. La ricerca ha dimostrato la capacità dell'OGM di identificare sottogruppi prognostici e rilevare riarrangiamenti genetici complessi in un unico flusso di lavoro, migliorando potenzialmente la classificazione e la gestione della malattia.
Bionano Genomics (NASDAQ:BNGO) anunció una publicación revisada por pares que demuestra la efectividad de su tecnología de mapeo genómico óptico (OGM) para detectar variantes estructurales oncogénicas en leucemia linfoblástica aguda de células T (T-ALL) en bebés y niños pequeños.
El estudio, realizado en varios centros pediátricos franceses, analizó 27 casos de T-ALL en niños menores de 3 años. Los hallazgos clave incluyen: el 33% de los casos presentaron reordenamientos del gen NKX2 no caracterizados previamente, perfiles genómicos distintos en comparación con niños mayores, y una tasa de supervivencia global a cinco años del 75,4%. La investigación demostró la capacidad del OGM para identificar subgrupos pronósticos y detectar reordenamientos genéticos complejos en un único proceso, mejorando potencialmente la clasificación y manejo de la enfermedad.
Bionano Genomics (NASDAQ:BNGO)는 유아 및 어린이 T세포 급성 림프모구성 백혈병(T-ALL)에서 종양 유발 구조 변이를 감지하는 광학 유전체 매핑(OGM) 기술의 효과를 입증한 중요한 동료 검토 논문을 발표했습니다.
프랑스의 여러 소아과 센터에서 수행된 이 연구는 3세 미만 어린이 27명의 T-ALL 사례를 분석했습니다. 주요 결과로는 33%의 사례에서 이전에 특성화되지 않은 NKX2 유전자 재배열이 발견되었고, 나이가 더 많은 어린이와는 다른 유전체 프로필을 보였으며, 5년 전체 생존율이 75.4%였습니다. 이 연구는 OGM이 예후 하위 그룹을 식별하고 복잡한 유전적 재배열을 단일 워크플로우에서 감지할 수 있음을 보여주어 질병 분류 및 관리 개선에 기여할 수 있음을 시사합니다.
Bionano Genomics (NASDAQ:BNGO) a annoncé une publication revue par des pairs démontrant l'efficacité de leur technologie de cartographie optique du génome (OGM) dans la détection de variants structurels oncogéniques dans la leucémie aiguë lymphoblastique T (T-ALL) chez les nourrissons et tout-petits.
Cette étude, menée dans plusieurs centres pédiatriques français, a analysé 27 cas de T-ALL chez des enfants de moins de 3 ans. Les résultats clés incluent : 33 % des cas présentaient des réarrangements du gène NKX2 non caractérisés auparavant, des profils génomiques distincts par rapport aux enfants plus âgés, et un taux de survie globale à cinq ans de 75,4 %. La recherche a démontré la capacité de l'OGM à identifier des sous-groupes pronostiques et à détecter des réarrangements génétiques complexes en un seul processus, améliorant potentiellement la classification et la prise en charge de la maladie.
Bionano Genomics (NASDAQ:BNGO) gab eine bedeutende peer-reviewte Veröffentlichung bekannt, die die Wirksamkeit ihrer optischen Genomkartierung (OGM) Technologie bei der Erkennung onkogener struktureller Varianten bei T-Zell akuter lymphatischer Leukämie (T-ALL) bei Säuglingen und Kleinkindern demonstriert.
Die Studie, die an mehreren französischen Kinderzentren durchgeführt wurde, analysierte 27 T-ALL-Fälle bei Kindern unter 3 Jahren. Wichtige Erkenntnisse umfassen: 33% der Fälle wiesen zuvor unbekannte NKX2-Genumlagerungen auf, unterschiedliche genomische Profile im Vergleich zu älteren Kindern sowie eine Gesamtüberlebensrate von 75,4% nach fünf Jahren. Die Forschung zeigte, dass OGM prognostische Untergruppen identifizieren und komplexe genetische Umlagerungen in einem einzigen Arbeitsablauf erkennen kann, was die Krankheitsklassifikation und -behandlung verbessern könnte.
- None.
- Study was retrospective and limited to 27 cases
- Technology still requires validation as a complementary tool rather than standalone solution
Insights
Bionano's OGM technology shows superior detection of critical genetic variants in infant T-ALL, potentially improving diagnostic capabilities and patient stratification.
This publication demonstrates significant clinical research utility for Bionano's Optical Genome Mapping (OGM) technology in a challenging pediatric cancer population. The study examined T-cell acute lymphoblastic leukemia (T-ALL) in infants and toddlers under 3 years old—a notoriously difficult group to analyze due to rarity and complexity.
The findings reveal OGM's exceptional capability to detect structural variants that conventional cytogenetics missed, particularly NKX2 rearrangements in 33% of cases. This is scientifically noteworthy as these genetic events hadn't been previously characterized in this age group. The technology also identified distinct genomic profiles differentiating infant/toddler T-ALL from older pediatric cases.
Most importantly, the study demonstrates OGM's ability to identify prognostic subgroups based on structural variants. Patients with NKX2, KMT2A, and STAG2::LMO2 alterations showed 100% overall survival, while those with TAL1 or ETS dysregulation had poorer outcomes. This stratification capability addresses a critical clinical need—accurately identifying which patients may need more aggressive treatment versus those who could potentially avoid unnecessary toxicity.
OGM's single-workflow capability represents a technical advantage over conventional screening methods that require multiple tests and still miss key variants. For rare and complex diseases like infant T-ALL, where comprehensive genomic data is scarce, OGM offers a more complete view of the genome, potentially streamlining the diagnostic process while improving accuracy.
SAN DIEGO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a peer-reviewed publication from a team led by Manon Delafoy from the Institut Necker Enfants Malades (INEM) and colleagues from multiple French pediatric hematology centers showing how optical genome mapping (OGM) can be used to detect oncogenic structural variants (SVs) in clinical research of infant and toddler T-cell acute lymphoblastic leukemia (T-ALL). The publication shows that OGM can reveal distinct genetic drivers and prognostic subgroups that conventional cytogenetics failed to identify in a retrospective, national cohort of 27 T-ALL cases of infants and toddlers (<3 years) as part of a combined workflow of targeted sequencing, OGM, and RNA sequencing. Infants and toddlers can be a difficult segment of the population to analyze because their cancers are rare. The study conclusions support using OGM as a complementary tool to conventional assays to help accurately stratify samples from infants and toddlers according to prognostic risk.
Key OGM Findings based on Retrospective Analysis
- NKX2 rearrangements in one-third of cases: In the French cohort,
33% of cases (9 of 27) infant/toddler T‑ALL cases carried NKX2 family gene rearrangements. These events had not been previously characterized in this age group and frequently co‑occurred with MYB alterations (5/9) or complex chromothripsis-like events (3/9) - Distinct genomic profile versus older pediatric subjects: Compared with a larger cohort of 245 cases aged 3-18 years, infant/toddler cases lacked TLX1/3 dysregulation but showed rates of TAL1/-like anomalies (
30% ), STAG2::LMO2 fusions (15% ), ETS rearrangements (15% ), and rarely, KMT2A rearrangements (7% ) - Comparable survival despite aggressive presentation: Despite higher rates of hyperleukocytosis and slower treatment response, these youngest subjects (infants and toddlers) achieved a 5-year overall survival (OS) of
75.4% (95% confidence interval [CI]:60.0% –94.8% ), closely matching the75.2% (95% CI:69.8% –81.1% ) seen in the older pediatric subjects (p = 0.86) in the retrospective cohort - Prognostic subgroups defined by structural variants in the retrospective analysis: Alterations in NKX2, KMT2A, and STAG2::LMO2 identified a subgroup with
100% overall survival (OS), whereas subjects with TAL1 or ETS dysregulation had less favorable outcomes. Findings were further supported by analysis of an independent cohort from the COG AALL0434 trial. - Single‑workflow capability of OGM: OGM enabled detection and precise sizing of cryptic or complex rearrangements in a single assay, streamlining genomic profiling, compared to conventional or standard screening methods that may miss key variants or require multiple tests
“This study represents a significant collaborative effort across leading centers in France and offers a substantial leap forward for the pediatric leukemia community. Studying T-ALL in infants and young children is difficult because data are scarce and the genomic landscape is complex. Furthermore, standard approaches can often miss critical variants. OGM can provide a more complete view of the genome, revealing structural alterations that would otherwise remain hidden, uncovering drivers that can guide how we classify these cases, which may one day lead to better disease management and treatment,” said Erik Holmlin, Bionano’s President and CEO.
The full research publication is available at: https://onlinelibrary.wiley.com/doi/epdf/10.1002/hem3.70154
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 “can,” “may,” “expect,” “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, the ability of OGM to reveal distinct genetic drivers and prognostic subgroups that conventional cytogenetics failed to identify in a national cohort of 27 T-ALL cases of infants and toddlers (<3 years) as part of a combined workflow of targeted sequencing, OGM, and RNA sequencing; the ability of OGM to provide a more complete view of the genome, revealing structural alterations that would otherwise remain hidden, uncovering drivers that can guide classification of cases; the ability of OGM to lead to better disease management and treatment; and any other statements 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 risks and uncertainties associated with: the failure of OGM to reveal distinct genetic drivers and prognostic subgroups that conventional cytogenetics failed to identify in a national cohort of 27 T-ALL cases of infants and toddlers (<3 years) as part of a combined workflow of targeted sequencing, OGM, and RNA sequencing; the failure of OGM to provide a more complete view of the genome, revealing structural alterations that would otherwise remain hidden, uncovering drivers that can guide classification of cases; the failure of OGM to lead to better disease management and treatment; study results that differ or contradict the results mentioned in this press release; 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 conflicts between Ukraine and Russia and Israel and Gaza 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 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 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
Investor Relations:
Kelly Gura
Gilmartin Group
+1 (212) 229-6163
IR@bionano.com
