Berry Genomics Co., Ltd. has announced 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 manufacture and market the system and assays in China for clinical use in selected indications. BioNano will continue to market its Irys® system in China to the rest of the research community, including genomics centers, governmental and academic institutions, translational research facilities and pharmaceutical companies.
“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. We sought to address all of these deficiencies with our upcoming product offering, and NGM was found to be the right approach,” said Daixing Zhou, Ph.D., CEO of Berry Genomics.
“As the clear leader in NGM, BioNano is our ideal partner. BioNano is the only company that provides a commercially viable method for the systematic and comprehensive detection of large. These variations are the roots of many human diseases and the existing technologies, including next generation sequencing, cannot readily and comprehensively find them.”
“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,” said Erik Holmlin, Ph.D., CEO of BioNano Genomics. “This partnership is an example of our goal of working with the leading clinical companies around the world that seek to take human disease diagnosis to the next level via our Irys® technology.”