NEW YORK (GenomeWeb) – BioNano Genomics said that a recent agreement it struck with Berry Genomics to bring its genome mapping instrument through China Food and Drug Administration approval would be a first step in inking regulatory approvals for its technology in other countries.
Earlier this month, the two firms said they would codevelop clinical assays on BioNano's Irys instrument to detect chromosomal variations that would be brought through CFDA approval.
BioNano's CEO Erik Holmlin told GenomeWeb that the firms will develop assays on the Irys system initially in the reproductive health space for pregnancy loss and other "supporting testing" that occurs in in vitro fertilization clinics. The companies also plan to eventually develop oncology tests, Holmlin said.
Berry Genomics declined to comment on its plans to develop clinical assays using BioNano's technology.
BioNano's Irys system images, maps, and analyzes single molecules of DNA. Last year, the company said that it planned to establish a diagnostic roadmap and develop a cytogenetics assay, although thus far, the system is primarily used for research. The Irys system is most commonly used in conjunction with next-generation sequencing to resolve regions of large structural variations, or to help with de novo assembly of human, animal, and plant genomes. The company's IrysSolve pipeline enables structural variant calling and haplotyping, but it has not launched any disease-specific assays. Holmlin said that the assays it develops with Berry will be standalone assays rather than assays used to supplement NGS data.
Holmlin said that the company would not have to make any substantial changes to the underlying technology, but would have to tailor the informatics solutions for specific assays and demonstrate specificity and sensitivity.
China has a number of unique requirements for clinical approval of genetic tests. Because the country does not have the equivalent designation of laboratory-developed tests, all genomic tests used for clinical approval must be brought through CFDA clearance.
In addition, the instrument and tests must be primarily manufactured in China. Berry Genomics already has experience in this area, having collaborated with Illumina to secure CFDA approval for a noninvasive prenatal test on a specially developed version of Illumina's NextSeq 500 instrument, Holmlin said. BioNano's would work with Berry would be similar to that collaboration, so that Berry would ultimately be responsible for the development, manufacturing, and assembly of a version of the Irys system in China, Holmlin added.
Another requirement of CFDA approval is that clinical trials must be conducted in China on Chinese samples, Holmlin said. Once BioNano and Berry develop the specific assays the companies will have to set up and run the trials to demonstrate the assay and system's performance, including analytical and clinical validations. He said it was still "premature" to give a timeline for approval or completion of the clinical trials. "We are now in the process of putting the plans together," he said. "It is early in the planning phase."
Similar to US Food and Drug Administration 510(k) clearance, both the system and a clinical assay will have to be cleared together. Subsequent tests that would run on the Irys would also have to be cleared, but the approval process would not be as lengthy since the system itself would already be cleared.
In addition, as part of the agreement Berry will have the rights to commercialize the clinical system upon CFDA approval. It will be able to run approved tests as services out of its own lab and will also be able to sell the clinical system and assay to hospitals that want to run the tests internally. "One key aspect of CFDA approval is … the ability to market the system and tests to hospital labs that have the appropriate level of qualifications" to run clinical tests, Holmlin said.
In the future, Holmlin said that BioNano's entry into the Chinese clinical market could help the company expand its clinical presence in other countries. "We would leverage any readiness driven by this project to accelerate regulatory clearances in other countries," Holmlin said. "There is some overlap that Chinese regulators have with other jurisdictions." Holmlin said that the firm has US FDA clearance on its roadmap as well as CE marking in Europe. However, he said that in the US, the Irys would likely be used first in the laboratory-developed test setting for clinical use.