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Berry Genomics, Illumina Seeking CFDA Approval for NIPT on Customized NextSeq 500

NEW YORK (GenomeWeb) – Chinese genetic testing firm Berry Genomics and Illumina have co-developed a next-generation sequencing system and are currently seeking approval for clinical applications from the Chinese Food and Drug Administration, the companies said today.

Under their partnership, the firms have developed a customized sequencer that is based on Illumina's NextSeq 500 and have integrated it with Berry's Bambni noninvasive prenatal test, which includes a PCR-free library prep kit and proprietary RUPATM analysis software.

After having validated a working version of the assay and instrument in a clinical setting in China, the system is now in late-stage review of the CFDA's medical device registration process.

The announcement comes after the CFDA and China's National Health and Family Planning Commission said earlier this year that it would require genetic tests to be regulated, prompting at least one provider of NIPT to halt testing.

Earlier this month, the CFDA approved a noninvasive prenatal test called NIFTY from BGI in conjunction with two sequencing systems, one based on Thermo Fisher's Ion Torrent platform, the other based on Complete Genomics' sequencing technology.

Berry Genomics started offering the Bambni test, which covers several chromosomal aneuploidies, in late 2011, initially on Illumina's HiSeq 2000. It has performed the test on more than 200,000 samples so far. Earlier this year, the firm said it was going to switch the test to the HiSeq 2500.

Besides Bambni, Berry was offering two other NGS-based tests as of earlier this year, one called Chromate for chromosomal duplications and deletions and another called Chrosure for preimplantation genetic diagnosis.