By Allison Proffitt
August 19, 2016 | BioNano Genomics has announced that its Irys platform for detecting genomic structural variations will serve as the foundation for a new system and assays developed with Berry Genomics for which Berry will seek Chinese Food and Drug Administration (CFDA) regulatory approval for a number of clinical indications in China.
“We’ll be looking in areas of women’s health,” said Erik Holmlin, BioNano’s CEO. “We’ll be complementing their existing portfolio in women’s health but bringing the structural variation perspective. That may expand into some oncology as well.”
Holmlin is enthusiastic about Berry’s track record. Two years ago, Berry submitted Illumina’s sequencing platform for CFDA approval in conjunction with a Berry non-invasive prenatal test. The platform was approved for clinical use, and Holmlin hopes Berry can get the same approval for the BioNano platform.
“BioNano is looking at the clinical opportunity in China because it’s a huge opportunity,” he told Dianostics World. “[We’re] working with Berry because they are absolutely the best partner for doing it, but that’s not our only path to clinical adoption in other regions. We have the opportunity to focus on a few indications, but we hope this grows into a multi-indication, long-term relationship that’s very beneficial to both parties.”
New Instrument, Assays
The Irys system includes both an instrument and consumables that are based on proprietary technology used to measure genome structure, Holmlin explained. Irys analyzes DNA isolated from clinical samples with single-molecule imaging to reveal insertions, deletions, copy number variations, translocations, segmental duplications, and other structural variations.
Under the new agreement, Berry and BioNano will co-develop a system to integrate proprietary assays designed by BioNano and Berry with a “next-generation mapping instrument based on BioNano’s Irys platform,” the company stated.
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. 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.
“The collaboration is intended to be something that really is co-development,” Holmlin said. “We’re working together to expand the clinical utility of the Irys system in certain indications. We have a structure that allows for ongoing research.”
“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, CEO of Berry Genomics, in the statement.
Holmlin said that BioNano is working toward clinical adoption in the United States as well, but intimated that BioNano will chose to develop the Irys platform as a laboratory developed test. “In the US we have a few different options for introducing technology into the clinical space, and one of those in the US is the laboratory-developed test route. That’s an option for us here in the US, but it’s not an option in China.”