Berry Genomics, Illumina Seek Chinese Regulatory Approval for NIPT

By Bio-IT World Staff 

 

July 21, 2014 | Berry Genomics has chosen Illumina next-generation sequencing (NGS) technology as the platform on which Berry hopes to secure Chinese Food and Drug Administration (CFDA) regulatory approval for clinical applications, thereby expanding access to NGS-based tests in China.

 

In March, China’s FDA banned sequencing-based testing, in what looked to be a temporary halt to prenatal testing in order for the government to set guidelines. But earlier this month, the regulatory body approved two sequencers and a non-invasive prenatal test.

 

Berry Genomics says the Illumina platform and Berry’s own proprietary non-invasive prenatal test (NIPT) have together been validated in clinical settings in China, and the combined system is in late stage review under the CFDA’s medical device registration process. The two companies are co-developing the NGS system to provide a cost-effective, easy-to-use assay for NIPT. 

 

The new system integrates Berry Genomics’ Bambni assay, which includes a library preparation kit, analysis software, (see, Fruitful Market: Berry Genomics Tackles Prenatal Testing in China) and a sequencing instrument based on Illumina’s NextSeq 500 Sequencing System. Berry’s proprietary Bambni assay, which has been validated on more than 200,000 samples, uses a unique PCR-free library prep technology and the proprietary RUPA analysis software, the company says. 

 

“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, in a statement. Zhou has previously served as Head of Sequencing Sales at Illumina-Asia Pacific Japan.

 

“Berry is one of the leading providers of NIPT in China, and Illumina is excited to collaborate with them to customize the NextSeq under CFDA requirements,” said Greg Heath, Senior Vice President, IVD Development at Illumina, in the same press release. “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.”