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Bionano Genomics Inks OEM Deal With Chinese Partner to Commercialize Clinical Cytogenetics Workflow

NEW YORK – Bionano Genomics said Wednesday that it has inked an original equipment manufacturing (OEM) agreement with Hangzhou Diagens Biotechnology for the commercialization of a clinical cytogenetic workflow involving its optical genome mapping technology in China.

Financial details of the deal were not disclosed.

Diagens, an assisted reproductive technology company that uses artificial intelligence for chromosome karyotyping, has already secured Class I registration and approval from China's National Medical Products Administration (NMPA) for Bionano's optical genome mapping reagents and plans to register the Saphyr instrument with the agency for clinical use in reproductive health.

The companies plan to commercialize a cytogenetic workflow that combines OGM and AI-based chromosome karyotype analysis to detect pathogenic structural variants linked to recurrent pregnancy loss and other genome variants that may impact pregnancy or lead to developmental issues in a newborn.

"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," Bionano President and CEO Erik Holmlin said in a statement. "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, preimplantation analysis of in vitro fertilized embryos, and other prenatal and postnatal genome analyses."

Diagens is Bionano’s third announced OEM partner in China. The San Diego-based firm previously inked OEM partnerships with A-smart MedTech and with Beijing Genome Precision Technology (BGPT), which both also obtained NMPA Class I registrations for Bionano's reagents.