Berry Genomics has selected BioNano Genomics’ Irys system to develop the novel chromosomal structural variation detection system.
Once the new system is developed, Berry plans to apply for the approval with the Chinese Food and Drug Administration (CFDA) to market it in the country.
The company is seeking approval for the system for multiple clinical indications in China.
Berry Genomics said 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 new system will incorporate proprietary assays designed by BioNano and Berry with a next-generation mapping instrument based on Irys platform.
As part of the deal, Berry will exclusively produce and market the system and assays in China for clinical use in selected indications.
BioNano will continue to market its Irys system in the country to the research community, including genomics centers, governmental and academic institutions, translational research facilities and pharmaceutical companies.
Berry Genomics CEO Dr Daixing Zhou said: “Chromosomal structural variation-based testing is a very rapidly expanding market in China and the existing detection modalities, such as karyotyping, FISH and microarrays, are slow, labor-intensive and oftentimes deficient in detecting the full spectrum of genetic variation.”
BioNano Genomics CEO Dr Erik Holmlin said: “Berry has become the leader in non-invasive prenatal testing in China through innovative offerings, and we seek to help Berry achieve that same level of leadership in a broad array of genetic diseases and cancer with our NGM platform.”
