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Annoroad Genomics receives approval for clinical genetic diagnostic devices

Apr 27, 2017 (China Knowledge) – Annoroad Genomics, a national hi-tech company well-known for its genetic research and bioinformatics with focus on developing novel diagnostic products and assisting life scientific research, has recently received medical device product registration approval from China Food and Drug Administration (China FDA). Its NextSeq 550AR sequencing system and fetal chromosome aneuploidy (T21, T18 and T13) the next-generation sequencing reagent kit are ready for the marketplace.


According to published reports from the China FDA the NextSeq 550AR sequencing system is a new generation desktop high-throughput sequencing platform co-developed with American Illumina Company, and was independently produced in the country. It is also considered as the most advanced clinical sequencing platform in the world.


Meanwhile, its Non-Invasive Prenatal Testing (NIPT) reagent kit or fetal chromosome aneuploidy (T21, T18 and T13), next-generation sequencing reagent kit, is able to test up to 96 NIPT clinical samples in one operation and it has realized a great breakthrough in data quality and data production.


Chen Chongjian, CEO of Annoroad Genomics, says that the NIPT opens up a new era of prenatal testing. Annoroad is one of the earliest laboratory to carry out the clinical application of such technology. As the first batch of national clinical pilot companies, the company has produced rapid development of NIPT technology and its clinical popularity.


As at the end of Oct 2016, the National Health and Family Planning Commission issued a new technical specification for NIPT, which is an important milestone in the standardization of the industry. "Annoroad has promoted the NIPT industry standardization process and hope to it could become a routine testing in hospitals. The approval for NextSeq 550AR means the completion of the whole industry chain layout for Annoroad and also marks the birth of China's most advanced high-throughput gene sequencer, which is bound to bring a positive impact on the clinical application of NIPT". Chen explained.

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