Berry Genomics Gets Premarket Clearance From Chinese FDA For NextSeq CN500

(RTTNews) - Berry Genomics Co., Ltd. announced that Hangzhou Berry Genomics, a subsidiary of Berry Genomics Co., Ltd., has received premarket clearance from the Chinese Food and Drug Administration or CFDA for the NextSeq CN500, a high throughput sequencing instrument developed with Illumina (ILMN) to meet Chinese clinical needs.

Hangzhou Berry Genomics also received premarket clearance for its non-invasive prenatal testing (NIPT) detection kit for trisomies 13, 18 and 21.

The NextSeq CN500 utilizes Illumina's sequencing by synthesis technology and was designed for operations in a clinical setting. Complementary with NextSeq CN500, Berry Genomics' NIPT kit is based on a proprietary PCR-free protocol, which simplifies the complex NIPT sample preparation process to a two-step workflow in a single tube. The system can process up to 96 samples per instrument run.