Berry Genomics chose Illumina's next-generation sequencing technology as the platform on which Berry will aim to secure Chinese Food and Drug Administration (CFDA) regulatory approval for clinical applications. The goal is to expand access to NGS-based tests in China.
The companies say have co-developed an NGS system to provide a cost-effective, easy-to-use assay for noninvasive prenatal testing. A working version of the new assay and instrument system has been validated in clinical settings in China, and is in late-stage review under the CFDA's medical device registration process.
The new system integrates Berry Genomics' Bambni™ assay, which includes a library preparation kit, analysis software, and a sequencing instrument based on Illumina's NextSeq™ 500 sequencing system.
"There are two million high-risk and advanced maternal age pregnancies a year in China, which is about three times the size of the U.S. market. We need to ensure we are addressing women's needs by offering a safe and proven technology. As the first and only company with a U.S. FDA cleared next-generation sequencing instrument, Illumina is an ideal collaboration partner given their experience," said Daixing Zhou, CEO of Berry Genomics.
"This agreement is an example of our commitment to working with clinical companies in China and worldwide who want to develop and commercialize in vitro diagnostics based on next-generation sequencing," added Greg Heath, svp, IVD development at Illumina.