Update: Targeted NIPT Technology Enters Clinical Use
Targeted NIPT Approved for Marketing by NMPA
recently, information from the database of the state drug administration showed that,Fetal Chromosome Aneuploidy (T21, T18, T13) Detection Kit Declared by Chengdu Nahai High-Tech Based on Targeted NIPT Technology(Medical Device Registration Certificate No.: Guoxie Note 20233401744) has been approved and officially listed by the China National Drug Administration (NMPA).this means another important innovation of non-invasive prenatal screening technology in China, and is expected to be extended to general screening.
Fetal chromosomal abnormalities (such as Down syndrome) is one of the main causes of birth defects, which is still lack of effective treatment. Prenatal screening and diagnosis are effective ways to prevent fetal chromosomal abnormalities. Non-invasive prenatal genetic testing for fetal chromosomal abnormalities (Noninvasive Prenatal Testing, NIPT) is the use of high-throughput sequencing technology,sequencing of cell-free DNA fragments (cfDNA) in maternal blood and interpretation of fetal genetic information for prenatal detection of related diseases.
NIPT technology solves the problem of low accuracy of maternal serological screening (referred to as Tang sieve), NIPT methods currently used in clinical practice at home and abroad are mainly whole genome low-depth sequencing. This technology path only randomly selects a certain number of DNA for high-throughput sequencing, and detects the target disease by analyzing whether the extracted DNA distribution is the same as the normal gene distribution. The technology can not be specific enrichment of known pathogenic genes, and the detection efficiency needs to be further improved.
-targeted NIPT refers to a new NIPT method that enriches DNA related to diseases such as Down syndrome in samples, especially DNA that may be different between fetus and pregnant women, and then performs high-throughput sequencing and analysis to obtain detection results. The advantage of targeting NIPT is that it has high detection efficiency for known diseases, can accurately identify fetal DNA and quantify its proportion in the peripheral blood of pregnant women, effectively reduce sequencing costs, improve detection efficiency, and further improve detection accuracy and reduce the risk of leakage.
Targeted NIPT Helps Non-invasive Prenatal Screening
at present, about 40% of pregnant women in China use the whole genome NIPT technology, which proves the effectiveness and necessity of NIPT technology to replace the traditional Tang sieve, the popularization rate and detection efficiency still need to be improved. After years of independent research and development, Chengdu Nahai Hi-Tech Biotechnology Co., Ltd. has solved the technical difficulties of targeting NIPT, and has completed large-scale, forward-looking and population-wide clinical verification in many well-known medical institutions in China in strict accordance with the registration supervision requirements. Targeted NIPT technology improves the detection efficiency and is an important supplement for the further promotion of NIPT to general screening. In the future, targeted NIPT technology can further expand the testing content for clinical needs and meet regulatory requirements, providing more choices and protection for all families and doctors at home and abroad.
