BioNano Genomics and Berry Genomicsto Co-Develop Next-Generation Mapping System for CFDA-Approved Clinical Use in China

BioNano’s Irys® chosen by Berry for the development, manufacture and marketing of a chromosomal

structural variation detection system for multiple clinical applications in China

SAN DIEGO & BEIJING – Berry Genomics Co., Ltd. announced today that it has chosen

BioNano Genomics’ Irys® system for next-generation mapping (NGM) as the platform on which Berry will seek Chinese Food and Drug Administration (CFDA) regulatory approval for a number of clinical indications in China.

Under the agreement, the companies will co-develop an NGM system to provide cost-effective, easy-to-use assays for detection of chromosomal structural variations. The new assays and instrument system are to be validated in clinical settings in China and submitted for review under the CFDA’s medical device registration process.

The system will integrate proprietary assays designed by BioNano and Berry with a next-generation mapping instrument based on BioNano’sIrys® platform. Berry will exclusively manu

BioNano Genomics and Berry Genomicsto Co-Develop Next-Generation Mapping System for CFDA-Approved Clinical Use in China

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