Berry Genomics Secures First NIPT Re-registration Certificate in China’s Gene Testing Industry

In August 2019, Hangzhou Berry Genomics Gene Diagnostics Co., Ltd. (hereinafter referred to as “Berry Genomics”), a wholly-owned subsidiary of Berry Genomics (SZ000710), received notification from the National Medical Products Administration that its application for the renewal of registration for the “Fetal Chromosomal Aneuploidy (T13/T18/T21) Detection Kit (Reversible Terminator Sequencing Method)” had been successfully approved. The approval date was August 6, 2019, with a validity period of five years. Berry Genomics became the first company in China’s genetic testing industry to complete the renewal registration for noninvasive prenatal testing (NIPT).

Since 2014, the National Medical Products Administration (formerly the China Food and Drug Administration) has progressively approved second-generation gene sequencing diagnostic products (NIPT) for clinical use. Meanwhile, it has required approved enterprises to continue collecting post-marketing clinical data from at least 10 clinical institutions, with a total of no fewer than 100,000 cases, as clinical materials for the next renewal registration. In accordance with this requirement, Berry Genomics has successfully completed the relevant work.

The successful renewal of Berry Genomics’ NIPT registration signifies that its product and service quality have once again garnered dual recognition from regulatory authorities and the market. This will significantly promote the widespread adoption and application of NIPT technology in clinical institutions across China, laying the foundation for it to become an essential tool for universal prenatal screening in the future.

To date, more than ten million pregnant women in China have undergone NIPT. As the technology continues to advance, the scope of NIPT testing will expand. With support from national policies, NIPT is poised to serve an even greater number of expectant mothers in the future.

As a leading enterprise in the genetic testing industry, Berry Genomics has been committed to the clinical translation of genetic testing technologies. It not only developed non-invasive prenatal testing (NIPT) technology but also pioneered its large-scale clinical application. Berry Genomics’ achievement as the first company in China’s genetic testing industry to complete registration renewal reflects its consistent commitment to product quality and sets a benchmark for clinical application standards and data quality criteria in the genetic testing sector.