Non-invasive Prenatal Testing (NIPT) applies advanced technologies for prenatal screening. It is a safe, accurate, and fast testing technique to screen fetal chromosomal abnormalities during early pregnancy. NIPT is getting popular in China after the Two-Child Policy was released in 2015. National Health and Family Planning Commission (NHFPC) published the newborn census as 18.46 million in 2016, of which second children were nearly half of the births. It is expected that the proportion of pregnant women age over 35 years old will be increased significantly. In 2015, the NIPT market was about 300 million US Dollars in China, it is estimated the revenue will reach 1.5 Billion US Dollars in 2017.
The NIPT upstream market in China is dominated by the local manufacturers, currently Berry Genomics（贝瑞和康）has No.1 market share in China. BGI(华大基因), DANA GENE(达安基因，ANNOROAD Genomics （安诺优达）and CapitalBio (博奥生物) are all in first Echelon in NIPT field and their NIPT products have received CFDA approval.
After NHFPC released "Notice of Prenatal Screening and Diagnosis of Fetal Free DNA in Peripheral Blood of Pregnant Women in a Standardized and Orderly "in 2016, more and more local governments in different provinces add NIPT to local Medical Insurance, that means the patients will do NIPT examinations with more affordable price.
Starting 2014, NIPT devices, reagents, and analysis software are required to receive CFDA approval before launching in the market. Till now, there are total seven local Gene Sequence Analyzers got CFDA Certificates, and they all classified as domestic Class III medical devices. BGI was the first company to get CFDA approval in June 2014 with its BGISEQ-1000 Gene Sequence Analyzer, Berry Genomics's NextSeq CN500 (cooperate with Illumina) got CFDA Certificate in March, 2015. The latest is ANNORAD, its NextSeq 550AR (cooperate with Illumina) got the CFDA Certificate in March, 2017, it is the fifth domestic NIPT manufacturer to get CFDA approval. There are very few of manufacturers in China investing for NIPT analysis software. Till now, there is no imported NIPT device received CFDA Certificate. The big challenge for foreign manufacturers to get CFDA approval is the time ad efforts to run clinical trial in China.
In August, 2016, National Institute for Food and Drug Control issued "General Guideline for Next Generation Sequencing Technology Detecting Reagent Quality Evaluation". Soon after, CFDA released "Guideline for registration of the Test Kit (High Throughput Sequencing Method) for Fetal Chromosome Aneuploidy (T21,T18,T13)" to guide the applicants in preparing for the regulatory submission in March 2017.
In order to encourage the research and innovation of medical device, and to promote its popularity and application, and to improve the development of medical industry in China, CFDA formulated "Special Review and Approval Procedure for Innovative Medical Device(interim) " in 2014. Based on the special review and approval procedure, if the CFDA registration application for Gene Sequencing products meets the definition of Innovative medical device, according to the principle of "Early Involvement, Dedicated Staff, Scientific Review and Approval", they can accelerate the whole CFDA approval process without lower the standards and reduce the procedure.
If you are interested in CFDA NIPT guidance and other related information, please feel free to contact me at julianiu@ramed.top.