Bionano Genomics announced that it has entered into an original equipment manufacturing, OEM, partnership agreement with Diagens. 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. Erik Holmlin, PhD, president and chief executive officer of Bionano, said, “We recognize the importance of AI in solving clinical bottlenecks and resolving other limitations, including the need for analysis and interpretation of data by highly trained individuals. We believe the transformative approach of combining OGM and AI in a cytogenetic workflow will advance SV detection in constitutional genetic disorder research that will have the potential to aid China’s large population seeking support for reproductive health, including genetic analysis of individuals considering pregnancy, pre-implantation analysis of in vitro fertilized embryos, and other prenatal and postnatal genome analyses.”
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