Berry Genomics has selected BioNano Genomics’ Irys system for next-generation mapping (NGM) as the platform on which it will seek approval of the Chinese regulatory authorities for a number of clinical indications.

As per the agreement, the two companies will jointly develop NGM system to offer cost-effective, easy-to-use assays for detection of chromosomal structural variations.

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These new assays and instrument system will be validated in clinical settings in China following which they will be submitted for review as per the Chinese Food and Drug Administration's (CFDA) medical device registration process.

"We sought to address all of these deficiencies with our upcoming product offering, and NGM was found to be the right approach."
 
Berry Genomics CEO 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.

“We sought to address all of these deficiencies with our upcoming product offering, and NGM was found to be the right approach.

“As the clear leader inNGM, BioNano is our ideal partner.

"BioNano is the only company that provides a commercially viable method for the systematic and comprehensive detection of large structural variations.

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"These variations are the roots of many human diseases and the existing technologies, including next-generation sequencing, cannot readily and comprehensively find them.”

The system will include proprietary assays designed by BioNano and Berry with a next-generation mapping instrument based on BioNano’s Irys platform.

Berry will manufacture and market the system and assays only for the Chinese market for clinical use in selected indications.

BioNano will continue to market its Irys system in China to genomics centers, governmental and academic institutions, etc.