Bionano and Diagens Sign Partnership to Commercialize the First Ever Clinical Cytogenetic Analysis that Combines OGM and Artificial Intelligence

• Bionano, a global leader in the transformation of the cytogenetic workflow with optical genome mapping (OGM), has entered into a strategic partnership with Hangzhou Diagens Biotechnology Co., Ltd. (Diagens), the pioneering leader in artificial intelligence (AI) chromosome karyotype analysis technology. Their joint endeavor aims to commercialize the first ever cytogenetic workflow that integrates OGM plus AI chromosome karyotype analysis
  
• Diagens will become an original equipment manufacturing (OEM) partner of Bionano in China
• Diagens has received Class I registration and approval for Bionano’s OGM reagents from China's National Medical Products Administration (NMPA) and plans to register the Saphyr instrument with NMPA for clinical use in reproductive health
• The cytogenetics workflow that Diagens expects to develop will combine AI analysis and OGM as a transformative approach to detecting pathogenic structural variants (SVs) associated with recurrent pregnancy loss and other significant genome variants that could impact a pregnancy or lead to developmental issues for the newborn 

SAN DIEGO, April 17, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO), a global leader in the transformation of the cytogenetic workflow with OGM, today announced that it has entered into an original equipment manufacturing (OEM) partnership agreement with Diagens, an assisted reproductive technology company based in China focused on the application of AI in cytogenetics. Through the partnership, the companies plan to commercialize the first ever cytogenetic workflow using OGM plus AI chromosome karyotype analysis to detect pathogenic SVs associated with recurrent pregnancy loss and other significant genome variants that may impact a pregnancy or lead to developmental issues in a newborn.

Diagens has received Class I registration and approval for Bionano’s OGM reagents from China's NMPA and will register the Saphyr instrument with NMPA for clinical use in reproductive health.

“As a pioneer in AI chromosome karyotype analysis, we are very happy to establish a partnership with Bionano and to jointly explore the reproductive health market. Diagens offers cutting-edge AI technology to help our customers to achieve a better overall success rate of in vitro fertilization. Bionano’s platform can help us achieve this goal as it can identify structural variations in a more precise way than karyotyping alone, and on a much broader scale. Additionally, we look forward to potentially expanding the cooperation into more fields, like blood cancer in the future,” stated Ning Song, PhD, chief executive officer of Diagens.