Bionano Announces Use of OGM in Preimplantation Genetic Testing as Part of Successful Live Birth to a Couple Experiencing Recurrent Pregnancy Loss
Bionano Genomics (BNGO) announced a breakthrough case study from Shenzhen Maternity and Child Healthcare Hospital, demonstrating the successful application of their optical genome mapping (OGM) technology in preimplantation genetic testing. The study showcases how OGM identified complex chromosomal rearrangements (CCRs) that were missed by traditional cytogenetic methods in a male partner of a couple experiencing recurrent pregnancy loss (RPL).
Using OGM as part of an in-vitro fertilization (IVF) and preimplantation genetic testing protocol, doctors were able to select the most viable embryo, resulting in a successful pregnancy and the birth of a healthy baby. This achievement is particularly significant as RPL affects millions worldwide, and infertility impacts 1 in 6 couples.
Bionano Genomics (BNGO) ha annunciato un caso studio rivoluzionario proveniente dall'ospedale materno-infantile di Shenzhen, dimostrando l'applicazione di successo della loro tecnologia di mappatura genomica ottica (OGM) nel testing genetico preimpianto. Lo studio illustra come l'OGM abbia identificato riarrangiamenti cromosomici complessi (CCR) che erano stati trascurati dai metodi citogenetici tradizionali nel partner maschile di una coppia che affrontava ripetuti aborti spontanei (RPL).
Utilizzando l'OGM come parte di un protocollo di fertilizzazione in vitro (IVF) e testing genetico preimpianto, i medici sono stati in grado di selezionare l'embrione più viabile, portando a una gravidanza di successo e alla nascita di un bambino sano. Questo successo è particolarmente significativo poiché il RPL colpisce milioni di persone in tutto il mondo e l'infertilità interessa 1 coppia su 6.
Bionano Genomics (BNGO) anunció un estudio de caso innovador del Hospital de Salud Materno-Infantil de Shenzhen, demostrando la aplicación exitosa de su tecnología de mapeo genómico óptico (OGM) en pruebas genéticas preimplantacionales. El estudio muestra cómo el OGM identificó reordenamientos cromosómicos complejos (CCR) que fueron pasados por alto por métodos citogenéticos tradicionales en un socio masculino de una pareja que experimentaba pérdidas recurrentes de embarazo (RPL).
Utilizando el OGM como parte de un protocolo de fertilización in vitro (IVF) y pruebas genéticas preimplantacionales, los médicos pudieron seleccionar el embrión más viable, lo que resultó en un embarazo exitoso y el nacimiento de un bebé sano. Este logro es particularmente significativo, ya que el RPL afecta a millones en todo el mundo, y la infertilidad impacta a 1 de cada 6 parejas.
Bionano Genomics (BNGO)는 선전 모자병원에서 혁신적인 사례 연구를 발표하며 그들의 광학 유전체 매핑 (OGM) 기술이 임신 전 유전자 검사에 성공적으로 적용된 것을 보여주었습니다. 이 연구는 OGM이 반복적인 유산(RPL)을 겪고 있는 부부의 남성 파트너에서 전통적인 세포유전학적 방법으로 놓쳤던 복잡한 염색체 배열(CCR)을 어떻게 식별했는지를 보여줍니다.
OGM을 체외수정(IVF) 및 임신 전 유전자 검사 프로토콜의 일환으로 사용하였으며, 의사들은 가장 생존력 있는 배아를 선택하여 성공적인 임신과 건강한 아기 출산으로 이어졌습니다. 이 성과는 RPL이 전 세계 수백만 명에게 영향을 미치고, 불임이 6쌍 중 1쌍에 영향을 준다는 점에서 특히 중요합니다.
Bionano Genomics (BNGO) a annoncé une étude de cas révolutionnaire provenant de l'hôpital de maternité et de santé infantile de Shenzhen, démontrant l'application réussie de leur technologie de cartographie génomique optique (OGM) dans le cadre des tests génétiques préimplantatoires. L'étude met en lumière comment l'OGM a identifié des réarrangements chromosomiques complexes (CCR) qui avaient été manqués par des méthodes cytogénétiques traditionnelles chez le partenaire masculin d'un couple souffrant de pertes de grossesse récurrentes (RPL).
En utilisant l'OGM dans le cadre d'un protocole de fécondation in vitro (FIV) et de tests génétiques préimplantatoires, les médecins ont pu sélectionner l'embryon le plus viable, aboutissant à une grossesse réussie et à la naissance d'un bébé en bonne santé. Cet exploit est particulièrement significatif car le RPL affecte des millions de personnes à travers le monde et l'infertilité touche 1 couple sur 6.
Bionano Genomics (BNGO) hat eine bahnbrechende Fallstudie aus dem Shenzhen Mutter-Kind-Gesundheitskrankenhaus angekündigt, die die erfolgreiche Anwendung ihrer optischen Genomkartierung (OGM) Technologie in der genetischen Testung vor der Implantation demonstriert. Die Studie zeigt, wie OGM komplexe chromosomale Umlagerungen (CCRs) identifizierte, die von traditionellen zytogenetischen Methoden übersehen wurden, bei einem männlichen Partner einer Paar, das wiederholt Schwangerschaftsverluste (RPL) erlitten hat.
Durch die Verwendung von OGM als Teil eines In-vitro-Fertilisation (IVF) und genetischen Testprotokolls vor der Implantation konnten die Ärzte den lebensfähigsten Embryo auswählen, was zu einer erfolgreichen Schwangerschaft und der Geburt eines gesunden Babys führte. Dieser Erfolg ist besonders bedeutend, da RPL Millionen von Menschen weltweit betrifft und Unfruchtbarkeit 1 von 6 Paaren betrifft.
- OGM technology demonstrated superior detection capabilities compared to traditional cytogenetic methods
- Successful clinical application validates OGM's effectiveness in reproductive medicine
- Addresses large market opportunity with RPL affecting millions and infertility affecting 1 in 6 couples
- None.
Insights
This case study demonstrates a significant clinical validation for Bionano's OGM technology in reproductive medicine. The successful identification of complex chromosomal rearrangements (CCRs) missed by traditional methods, leading to a successful pregnancy and birth, showcases OGM's superior detection capabilities. In simpler terms, their technology helped doctors find genetic problems that other tests missed, ultimately helping a couple have a healthy baby.
The addressable market is substantial - with 1 in 6 couples affected by infertility and millions experiencing recurrent pregnancy loss globally. This translates to a potential market worth billions in the reproductive medicine sector. The successful case study could drive adoption in fertility clinics worldwide, particularly in regions with advanced healthcare systems and higher IVF utilization rates.
However, investors should note that while this is a promising clinical validation, broader commercial adoption will require additional successful cases, regulatory approvals and reimbursement pathway development. The company's small market cap of
The technical achievement here is remarkable - OGM detected complex chromosomal rearrangements that traditional cytogenetic methods failed to identify. Think of it like having a super-powered microscope that can see genetic problems that regular microscopes miss. This capability could revolutionize preimplantation genetic testing.
The successful outcome validates OGM's precision in a high-stakes clinical setting. For the reproductive medicine field, this represents a potential paradigm shift in how we approach genetic testing for challenging fertility cases. The ability to better identify chromosomal issues could significantly improve success rates in assisted reproduction, particularly for couples with complex genetic factors.
The publication in a peer-reviewed setting adds credibility and could accelerate adoption among fertility specialists. While this is a single case study, the complexity of the case and successful outcome provide a compelling proof-of-concept for OGM's utility in reproductive medicine.
- OGM uniquely identified a complex chromosomal rearrangement missed by classical cytogenetics, helping clinical researchers apply targeted screening to select the most fit embryos for transfer
- Following in-vitro fertilization, preimplantation genetic testing and selection of fit embryos, a healthy baby was born to a couple that had previously experienced years of recurrent pregnancy loss
SAN DIEGO, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced publication of a case study from the Shenzhen Maternity and Child Healthcare Hospital, China, demonstrating the application of optical genome mapping (OGM) in a protocol for preimplantation genetic testing for structural rearrangements (PGT-SR). In-vitro fertilization (IVF) and the PGT-SR protocol, which included OGM, led to selection of the presumed most viable embryos, resulting in a viable pregnancy and the birth of a healthy baby to a couple experiencing years of recurrent pregnancy loss (RPL).
The couple had experienced years of RPL due, presumably, to complex chromosomal rearrangements (CCRs) identified in the male partner. OGM revealed previously undetected CCRs in the male that traditional cytogenetic methods had missed. The OGM findings helped to inform embryo selection to identify and transfer the presumed most viable embryo, which resulted in pregnancy. Prenatal testing during the pregnancy confirmed a normal karyotype, and the pregnancy went to full term and live birth with the couple welcoming a healthy baby.
Erik Holmlin, president and chief executive officer of Bionano commented, “This case study suggests that OGM could play a role in helping people experiencing infertility or RPL achieve their dreams of parenthood. RPL affects millions of people worldwide and infertility affects 1 in 6 couples, so this research could be a significant breakthrough. We couldn’t be prouder to have OGM be a part of this successful pregnancy and healthy live birth.”
The full research publication is available at: A healthy live birth after preimplantation genetic testing for structural rearrangements and Bionano revealed exceptionally complex chromosome rearrangements.
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,” “suggest,” 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 or current expectations concerning, among other things, OGM’s ability to detect CCRs missed by classical cytogenetics; the ability and utility of OGM to be used in applications such as PGT-SR; the ability and utility of OGM data to be useful for the selection of viable embryos; 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: global and macroeconomic events, such as recent and potential bank failures, supply chain disruptions, global pandemics, inflation, and the ongoing conflicts between Ukraine and Russian and Israel and Hamas, 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; the failure of OGM to detect CCRs missed by classical cytogenetics; the failure or inability of OGM to be useful in applications such as PGT-SR; the failure of inability of OGM data to be useful for the selection of viable embryos; the failure of OGM to be useful for the applications described in the publication referenced in this press release; future publications that contradict the findings of the publication referenced in this press release; 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 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, 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 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.
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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