Bionano Announces French Publication of an Effective Method for Analysis of Multiple Myeloma by OGM
Bionano Genomics (BNGO) has announced a breakthrough study published in The Journal of Molecular Diagnostics regarding the analysis of multiple myeloma (MM) using optical genome mapping (OGM). The research, conducted at Lille University Hospital, France, demonstrates an innovative method that reduces the required number of CD138-positive cells by half for MM analysis.
The study revealed that mixing CD138-positive and negative cells in a 1:1 ratio is sufficient for OGM analysis, requiring only 0.5 million CD138-positive cells instead of the typical 1 million. The method achieved 93% concordance with traditional FISH testing while detecting 22 additional genetic variants. This advancement streamlines laboratory workflows by consolidating multiple tests into a single comprehensive approach and improves prognostic risk evaluation through more detailed genomic profiling.
Bionano Genomics (BNGO) ha annunciato uno studio innovativo pubblicato su The Journal of Molecular Diagnostics riguardante l'analisi del mieloma multiplo (MM) utilizzando il mapping genomico ottico (OGM). La ricerca, condotta presso l'Ospedale Universitario di Lille, Francia, dimostra un metodo innovativo che riduce di metà il numero necessario di cellule positive al CD138 per l'analisi del MM.
Lo studio ha rivelato che mescolare cellule positive e negative al CD138 in un rapporto di 1:1 è sufficiente per l'analisi OGM, richiedendo solo 0,5 milioni di cellule positive al CD138 invece del tipico milione. Il metodo ha raggiunto una concordanza del 93% con i test FISH tradizionali, rilevando 22 varianti genetiche aggiuntive. Questo progresso semplifica i flussi di lavoro di laboratorio consolidando più test in un'unica approccio completo e migliora la valutazione del rischio prognostico attraverso un profilo genomico più dettagliato.
Bionano Genomics (BNGO) ha anunciado un estudio innovador publicado en The Journal of Molecular Diagnostics sobre el análisis de mieloma múltiple (MM) utilizando mapeo genómico óptico (OGM). La investigación, realizada en el Hospital Universitario de Lille, Francia, demuestra un método innovador que reduce a la mitad el número requerido de células positivas para CD138 para el análisis de MM.
El estudio reveló que mezclar células positivas y negativas para CD138 en una proporción de 1:1 es suficiente para el análisis OGM, requiriendo solo 0.5 millones de células positivas para CD138 en lugar del típico millón. El método logró una concordancia del 93% con las pruebas FISH tradicionales, detectando 22 variantes genéticas adicionales. Este avance simplifica los flujos de trabajo en el laboratorio al consolidar múltiples pruebas en un único enfoque integral y mejora la evaluación del riesgo pronóstico a través de un perfil genómico más detallado.
Bionano Genomics (BNGO)는 다발성 골수종 (MM)의 분석에 대한 광유전체 매핑 (OGM)을 사용한 혁신적인 연구를 The Journal of Molecular Diagnostics에 발표했습니다. 이 연구는 프랑스 리르 대학교 병원에서 수행되었으며, MM 분석에 필요한 CD138 양성 세포의 수를 절반으로 줄이는 혁신적인 방법을 보여줍니다.
연구 결과, CD138 양성 세포와 음성 세포를 1:1 비율로 혼합하는 것만으로도 OGM 분석이 가능하며, 일반적인 100만 개 대신 단 50만 개의 CD138 양성 세포만 필요하다는 것이 밝혀졌습니다. 이 방법은 전통적인 FISH 테스트와 93%의 일치를 이루었으며, 22개의 추가 유전적 변이를 감지했습니다. 이 발전은 여러 테스트를 단일 포괄적 접근으로 통합하여 실험실 작업 흐름을 간소화하고, 보다 상세한 유전체 프로파일링을 통해 예후 위험 평가를 개선합니다.
Bionano Genomics (BNGO) a annoncé une étude révolutionnaire publiée dans The Journal of Molecular Diagnostics concernant l'analyse du myélome multiple (MM) utilisant le mapping génomique optique (OGM). La recherche, réalisée à l'Hôpital Universitaire de Lille, en France, démontre une méthode innovante qui réduit de moitié le nombre requis de cellules positives au CD138 pour l'analyse du MM.
L'étude a révélé que le mélange de cellules positives et négatives au CD138 dans un rapport de 1:1 est suffisant pour l'analyse OGM, nécessitant seulement 0,5 million de cellules positives au CD138 au lieu du million habituel. La méthode a atteint une concordance de 93% avec les tests FISH traditionnels tout en détectant 22 variantes génétiques supplémentaires. Cette avancée rationalise les flux de travail en laboratoire en consolidant plusieurs tests en une approche complète et améliore l'évaluation du risque pronostique grâce à un profilage génomique plus détaillé.
Bionano Genomics (BNGO) hat eine bahnbrechende Studie veröffentlicht, die im The Journal of Molecular Diagnostics über die Analyse von multiplem Myelom (MM) mittels optischer Genomkartierung (OGM) berichtet. Die Forschung, die am Universitätsklinikum Lille in Frankreich durchgeführt wurde, zeigt eine innovative Methode, die die erforderliche Anzahl an CD138-positiven Zellen für die MM-Analyse um die Hälfte reduziert.
Die Studie ergab, dass die Mischung von CD138-positiven und -negativen Zellen im Verhältnis 1:1 für die OGM-Analyse ausreichend ist, wobei nur 0,5 Millionen CD138-positive Zellen anstelle der typischen 1 Million benötigt werden. Die Methode erzielte eine 93%ige Übereinstimmung mit traditionellen FISH-Tests und entdeckte 22 zusätzliche genetische Varianten. Dieser Fortschritt rationalisiert die Laborabläufe, indem mehrere Tests in einem umfassenden Ansatz zusammengefasst werden, und verbessert die prognostische Risikobewertung durch detailliertere genomische Profile.
- Developed more efficient method requiring 50% fewer cells for MM analysis
- Achieved 93% concordance with current standard while detecting 22 additional genetic variants
- Streamlined workflow by consolidating multiple tests into single comprehensive approach
- Technology adoption expanding in France through FrOGG and GFCH organizations
- None.
Insights
Bionano's latest publication in The Journal of Molecular Diagnostics represents a significant technical advancement for their Optical Genome Mapping (OGM) technology in multiple myeloma testing. The study solves a critical challenge in MM analysis by reducing the required CD138-positive cell count from 1 million to just 500,000, effectively doubling the potential sample pool that can be analyzed.
What's particularly noteworthy is the 93% concordance with FISH (the current standard method) while simultaneously detecting 22 additional genetic variants missed by traditional techniques. This suggests OGM offers both validation against established methods and superior sensitivity for comprehensive genomic profiling.
The workflow advantages shouldn't be overlooked - consolidating multiple separate tests (karyotyping and FISH panels) into a single comprehensive analysis represents both laboratory efficiency and potentially improved diagnostic yield from patient samples. For multiple myeloma patients, more comprehensive genomic analysis directly impacts risk stratification and treatment selection.
The endorsement from French cytogenetics groups and inclusion of OGM as an alternative to legacy methods signals growing clinical acceptance. Multiple myeloma represents one of the most common hematologic malignancies, with approximately 35,000 new cases diagnosed annually in the US alone, creating a substantial market opportunity if adoption continues to grow.
SAN DIEGO, April 08, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a study published in The Journal of Molecular Diagnostics that describes a method for analysis of multiple myeloma (MM) by optical genome mapping (OGM). MM is one of the most common blood cancers, or hematologic malignancies, and is understood to be a difficult sample to analyze using traditional cytogenetics. Direct analysis of MM samples, by methods such as FISH or OGM, can be problematic because it is challenging to isolate enough cells with a known MM marker (CD138) on their surface, so-called CD138-positive cells. In this paper, researchers at Institute of Medical Genetics, Lille University Hospital, Lille, France, have described a method for OGM that can overcome the hurdle of limited sample quantity and can cut in half the effective CD138-positive cell requirement for analysis by OGM.
Key Findings and Takeaways
- Mixing CD138-positive with CD138-negative cells from the same sample at a ratio of 1:1 can be sufficient to perform OGM. Since OGM typically requires 1 million cells, this finding suggests that as few as 0.5 million of the CD138-positive cells are sufficient
- OGM reveals More Genetic Events: Achieving
93% (13/15) concordance with FISH, the current standard, OGM also uncovered more than 22 additional genetic variants that were previously undetected by FISH - OGM Streamlines the Analysis: Consolidating multiple assessments (KT and multiple FISH assays) into a single, comprehensive approach using OGM can be more efficient and maximize the value of scarce cell samples while simplifying laboratory workflows and reducing the need for separate, time-consuming tests
- OGM Improves Prognostic Risk Evaluation: By capturing both primary and novel potentially pathogenic variants, OGM provides a comprehensive genomic profile that can be used to support more precise prognostic risk stratification
“Multiple myeloma is one of the most requested cancer types by customers seeking to implement OGM in routine use. We believe this publication marks an important advancement for OGM research in hematologic malignancies. The senior author, Dr Daudignon, has been among the pioneers spearheading the adoption of OGM in France through the French Optical Genome Mapping Group (FrOGG) and has included OGM as an alternative to legacy cytogenetic methods on behalf of the Groupe Francophone de Cytogénétique Hématologique (GFCH) for the evaluation of MM. This simple approach to OGM analysis of MM can offer the opportunity for researchers to expand their OGM menus to include a prevalent blood cancer with a significant unmet medical need,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano.
The full research publication is available at: https://www.jmdjournal.org/article/S1525-1578(25)00035-2/fulltext
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 “believe,” “can,” “may” 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 produce concordant results with FISH and other traditional cytogenetic methods for analyzing MM samples; the ability of OGM to identify new genetic variants for MM not identified with traditional cytogenetic methods; the ability of OGM to be more efficient than traditional cytogenetic methods; the ability to achieve results similar to those referenced in this press release using the methods described therein; the importance of the publication referenced in this press release to prove to be an important advancement in MM research; the ability and utility of the method described in this press release to further open researchers’ ability to expand their OGM menu; and 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 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 to produce concordant results with FISH and other traditional cytogenetic methods for analyzing MM samples; the failure of OGM to identify new genetic variants for MM not identified with traditional cytogenetic methods; the failure of OGM to be more efficient than traditional cytogenetic methods; the inability to achieve results similar to those referenced in this press release using the methods described therein; the failure of the publication referenced in this press release to prove to be an important advancement in MM research; the failure of the method described in this press release to further open researchers’ ability to expand their OGM menu; 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, 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:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com
FAQ
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