Bionano Announces Publication of First Multi-Site Study to Analyze the Utility of OGM in Multiple Myeloma
Bionano Genomics (Nasdaq: BNGO) announced the publication of the first multi-site study comparing optical genome mapping (OGM) to traditional cytogenetic methods for detecting structural variants in multiple myeloma (MM). The study, conducted by researchers at UT MD Anderson Cancer Center and Johns Hopkins Hospital, analyzed 45 plasma cell neoplasm samples using various methods.
Key findings include:
- OGM achieved 100% sensitivity, specificity, and accuracy in CD138 selected cases
- OGM detected high-risk factors and rearrangements undetected by FISH
- In 18% of cases, OGM changed prognostication beyond standard cytogenetics/FISH analysis
- OGM identified 366 novel structural variants potentially relevant to MM development
The study highlights OGM's potential to provide researchers with comprehensive genome-wide analysis in MM, potentially leading to greater adoption in cancer research labs.
Bionano Genomics (Nasdaq: BNGO) ha annunciato la pubblicazione del primo studio multicentro che confronta la mappatura genomica ottica (OGM) con i metodi citogenetici tradizionali per la rilevazione di varianti strutturali nel mieloma multiplo (MM). Lo studio, condotto da ricercatori del UT MD Anderson Cancer Center e del Johns Hopkins Hospital, ha analizzato 45 campioni di neoplasia a cellule plasmatica utilizzando vari metodi.
I risultati chiave includono:
- OGM ha raggiunto il 100% di sensibilità, specificità e accuratezza nei casi selezionati di CD138
- OGM ha rilevato fattori ad alto rischio e riarrangiamenti non individuati da FISH
- Nel 18% dei casi, OGM ha modificato la prognosi oltre l'analisi citogenetica/FISH standard
- OGM ha identificato 366 nuove varianti strutturali potenzialmente rilevanti per lo sviluppo del MM
Lo studio evidenzia il potenziale dell'OGM di fornire agli studiosi un'analisi genomica completa nel MM, portando potenzialmente a una maggiore adozione nei laboratori di ricerca sul cancro.
Bionano Genomics (Nasdaq: BNGO) anunció la publicación del primer estudio multicéntrico que compara la mapeo óptico del genoma (OGM) con métodos citogenéticos tradicionales para detectar variantes estructurales en mieloma múltiple (MM). El estudio, realizado por investigadores del UT MD Anderson Cancer Center y del Johns Hopkins Hospital, analizó 45 muestras de neoplasia de células plasmáticas utilizando varios métodos.
Los hallazgos clave incluyen:
- OGM alcanzó un 100% de sensibilidad, especificidad y precisión en los casos seleccionados de CD138
- OGM detectó factores de alto riesgo y reordenamientos no detectados por FISH
- En el 18% de los casos, OGM cambió la prognosticación más allá del análisis citogenético/FISH estándar
- OGM identificó 366 nuevas variantes estructurales potencialmente relevantes para el desarrollo de MM
El estudio destaca el potencial de OGM para proporcionar a los investigadores un análisis del genoma completo en MM, lo que podría llevar a una mayor adopción en laboratorios de investigación sobre el cáncer.
Bionano Genomics (Nasdaq: BNGO)는 구조적 변이를 탐지하기 위한 전통적인 세포유전학적 방법들과 비교하여 광유전체 매핑(OGM)에 대한 첫 번째 다중 사이트 연구의 발표를 알렸습니다. 이 연구는 UT MD Anderson Cancer Center와 Johns Hopkins Hospital의 연구자들에 의해 수행되었으며, 45개의 혈장 세포 신생물 샘플을 다양한 방법으로 분석했습니다.
주요 발견 사항은 다음과 같습니다:
- OGM은 CD138 선택 사례에서 100%의 민감도, 특이도 및 정확도를 달성했습니다.
- OGM은 FISH에 의해 발견되지 않은 고위험 인자 및 재배치를 탐지했습니다.
- 18%의 경우에 OGM이 표준 세포유전학/FISH 분석을 초월한 예후를 변화시켰습니다.
- OGM은 MM 발달과 관련이 있을 수 있는 366개의 새로운 구조적 변이를 식별했습니다.
이 연구는 MM에서 연구자들에게 포괄적인 유전체 분석을 제공할 수 있는 OGM의 가능성을 강조하며, 이는 암 연구실에서의 더 큰 채택으로 이어질 수 있습니다.
Bionano Genomics (Nasdaq: BNGO) a annoncé la publication de la première étude multicentrique comparant le mapping génomique optique (OGM) aux méthodes cytogénétiques traditionnelles pour la détection des variants structurels dans le myélome multiple (MM). L'étude, réalisée par des chercheurs du UT MD Anderson Cancer Center et de l'Hôpital Johns Hopkins, a analysé 45 échantillons de néoplasie des cellules plasmatiques à l'aide de diverses méthodes.
Les principaux résultats comprennent :
- OGM a atteint 100 % de sensibilité, de spécificité et de précision dans les cas sélectionnés CD138
- OGM a détecté des facteurs de risque élevés et des réarrangements non décelés par FISH
- Dans 18 % des cas, OGM a modifié la pronostic au-delà de l'analyse cytogénétique/FISH standard
- OGM a identifié 366 nouveaux variants structurels potentiellement pertinents pour le développement de MM
L'étude souligne le potentiel de l'OGM à fournir aux chercheurs une analyse génomique complète dans le MM, ce qui pourrait entraîner une adoption plus large dans les laboratoires de recherche sur le cancer.
Bionano Genomics (Nasdaq: BNGO) gab die Veröffentlichung der ersten Multizentrenstudie bekannt, die die optische Genomkartierung (OGM) mit traditionellen zytogenetischen Methoden zum Nachweis von strukturellen Varianten bei multiplem Myelom (MM) vergleicht. Die Studie, die von Forschern des UT MD Anderson Cancer Center und des Johns Hopkins Hospital durchgeführt wurde, analysierte 45 Plasmazell-Neoplasmen-Stichproben mit verschiedenen Methoden.
Wichtige Ergebnisse umfassen:
- OGM erreichte eine 100%ige Sensitivität, Spezifität und Genauigkeit in CD138-ausgewählten Fällen
- OGM entdeckte Hochrisikofaktoren und Umstellungen, die von FISH nicht erkannt wurden
- In 18% der Fälle änderte OGM die Prognose über die standardmäßige zytogenetische/FISH-Analyse hinaus
- OGM identifizierte 366 neuartige strukturelle Varianten, die potenziell relevant für die MM-Entwicklung sind
Die Studie hebt das Potenzial von OGM hervor, Forschern eine umfassende genomweite Analyse bei MM zu bieten, was möglicherweise zu einer breiteren Anwendung in Forschungslaboren für Krebs führen könnte.
- OGM achieved 100% sensitivity, specificity, and accuracy in CD138 selected cases, outperforming traditional methods
- OGM detected additional high-risk factors and rearrangements undetected by FISH in 18% of cases
- OGM identified 366 novel structural variants potentially relevant to MM development, enhancing understanding of the disease
- In 18% of cases, OGM provided information to predict response to targeted therapies, potentially improving treatment selection
- None.
Insights
The recent multi-site study published by Bionano Genomics marks a significant milestone in the field of cancer genomics, particularly for multiple myeloma (MM). Optical Genome Mapping (OGM) has demonstrated superior capabilities compared to traditional cytogenetic methods like FISH, CMA and KT. In the study, OGM uniquely identified complex genomic rearrangements in 18% of the cases, which could potentially lead to more precise prognostications and better-targeted therapies. This suggests that OGM can fill critical gaps left by other methods due to its higher sensitivity and accuracy, especially in detecting structural variants and complex gene rearrangements in MM.
For retail investors, the short-term implications are promising as OGM's unique findings could drive increased adoption in research labs, potentially boosting Bionano's revenues. Long-term, the ability of OGM to provide deeper insights into MM could result in the development of more effective treatments, enhancing Bionano's position in the genomics market. The study's findings reveal a substantial unmet need in the accurate detection of genomic abnormalities in MM, positioning Bionano's technology as a critical tool in cancer research.
From a financial perspective, the publication of this study could be a catalyst for Bionano Genomics' stock. The demonstrated utility of OGM in a challenging cancer like multiple myeloma underscores the potential for increased market penetration. If the technology gains traction in academic and clinical labs, it could significantly boost the company's revenue streams. Additionally, the ability to provide more precise prognostications and tailor therapies more effectively could make OGM an indispensable tool in oncological research.
For investors, this news is a positive indicator of Bionano's growth prospects. The company's stock might see upward movement as the market digests the implications of these findings. In the long term, increased adoption of OGM could translate into sustained revenue growth and a more robust market position for Bionano.
As an oncologist, the implications of this study are profound. Multiple myeloma is notoriously difficult to assess due to the fragile nature of plasma cells and the limitations of traditional methodologies. Optical Genome Mapping (OGM) offers a non-culture-based alternative that can detect complex structural variants and rearrangements with high accuracy. This capability is important for patient risk stratification and selecting appropriate therapeutic strategies.
The identification of actionable genetic abnormalities in 18% of cases, which were missed by other methods, suggests that OGM could become a standard practice in MM diagnostics. This can lead to more personalized treatment plans, improving patient outcomes. For the medical community, this represents a step forward in understanding and treating multiple myeloma more effectively.
SAN DIEGO, July 23, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO), today announced the publication of the first multi-site study in multiple myeloma (MM) comparing optical genome mapping (OGM) to traditional cytogenetic methods for the detection of structural variants (SVs).
Multiple myeloma is a type of blood cancer originating in the plasma cell, known as a plasma cell neoplasm (PCN), and though sensitive and accurate identification of genetic abnormalities in MM samples is critical for patient risk stratification, predication of response to therapy options, and understanding of pathogenesis, many genome analysis methodologies, including fluorescence in situ hybridization (FISH) and chromosomal microarray (CMA), are limited in their ability to detect complex gene rearrangements in PCN samples. Additionally, karyotype (KT) fails for PCNs at a higher rate than for leukemias because plasma cells are fragile and grow poorly in culture, leaving additional unmet need. Because OGM doesn’t require culture, it may be well suited to fill this gap.
In this study, conducted by researchers at University of Texas MD Anderson Cancer Center and The Johns Hopkins Hospital, researchers concurrently analyzed 45 PCN samples using KT, FISH, OGM, and next-generation sequencing (NGS). OGM uniquely identified complex genomic rearrangements that are associated with cancer proliferation and progression, resulting in a change in prognostication beyond that indicated by traditional cytogenetic analysis in
Key findings:
- Compared to FISH, OGM achieved
100% sensitivity, specificity, and accuracy in cases after CD138 selection and96.6% sensitivity,100% specificity, and98.3% accuracy in unselected cases - OGM detected gains of chromosome 1q in several samples, a known high-risk factor in MM
- OGM revealed 18 hyperdiploidy, 4 hypodiploidy, and 9 IGH or MYC rearrangements undetected by FISH
- In
18% of cases (8 out of 45), OGM identified chromoanagenesis that was undetected by FISH - In
18% of cases (8 out of 45), OGM changed the prognostication beyond that indicated by standard cytogenetics/FISH analysis - OGM detected 366 novel structural variants and copy number variants that are potentially relevant to the formation and development of MM
“Though many research studies demonstrate OGM’s utility in leukemias and other blood cancers, we were pleased to see robust findings from the first multi-site study of OGM in multiple myeloma, which is a blood cancer that is more difficult for researchers to assess. OGM has the potential to identify pathogenically relevant variants missed by other methods that further our understanding of MM, which we believe may lead to greater adoption of the workflow in labs focused on cancer research,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano.
The publication can be viewed here.
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.
Forward-Looking Statements of Bionano
This press release contains forward-looking statements contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “ability,” “believe,” “can,” “may,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances and the negatives thereof) 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 detect SVs missed by other cytogenetic methods, including KT, FISH, and CMA; the ability and utility of OGM to provide highly sensitive, accurate genome-wide analysis, that can lead to a more comprehensive understanding of genetic subtypes in PCN when compared with FISH and KT; the ability and utility of OGM to detect SVs relevant to multiple myeloma; the ability of OGM to provide results that are concordant traditional methods, including FISH and KT; the ability of OGM to detect SVs that are relevant to prognostication; and other statements that are not historical facts.
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 impact of geopolitical and macroeconomic developments, such as recent and future bank failures, the ongoing conflicts between Ukraine and Russia and Israel and Hamas, and related sanctions, and any global pandemics, inflation, or supply disruptions, on our business and the global economy; challenges inherent in developing, manufacturing and commercializing products; our ability to further deploy new products and applications and expand the markets for our technology platforms; the failure of OGM to detect SVs missed by other cytogenetic methods, including KT, FISH, and CMA; the failure of OGM to provide highly sensitive, accurate genome-wide analysis, that can lead to a more comprehensive understanding of genetic subtypes in PCN when compared with FISH and KT; the failure of OGM to detect SVs relevant to multiple myeloma; the failure of OGM to provide results that are concordant traditional methods, including FISH and KT; the failure of OGM to detect SVs that are relevant to prognostication; future study results that contradict or do not support the study results described in this press release; 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 obtain sufficient financing to fund our strategic plans and commercialization efforts; our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of institutions to obtain funding to support adoption or continued use of our technologies; and including the risks and uncertainties described in our filings with the Securities and Exchange Commission, 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 Securities and Exchange Commission. 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 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:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com
FAQ
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