NEW YORK – Bionano Genomics said Friday that its original equipment manufacturing (OEM) partner Hangzhou Diagens Biotechnology has obtained Class II registration and approval from China's National Medical Products Administration (NMPA) for the Saphyr optical genome mapping instrument.
With the approval — dated Dec. 30, 2024, according to NMP's website — Diagens can now sell the Saphyr platform directly to Chinese hospitals and clinical laboratories for clinical use, Bionano said.
Bionano inked an OEM agreement with Diagens in April 2024. At the time, Diagens, an assisted reproductive technology company that uses artificial intelligence for chromosome karyotyping, had already secured NMPA Class I registration and approval for Bionano's OGM reagents for clinical use in reproductive health.
Diagens also said it plans 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.
In an email, Bionano President and CEO Erik Holmlin said there are "multiple" other OEM partners that have started to register the Saphyr system with the NMPA for clinical use and "are expecting approval soon." According to Holmlin, each partner needs to obtain its own approval, which is specific to the manufacturer.
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.