Recently, the "Chromosomal aneuploidy and Gene Microdeletion Detection Kit (Reversible End Termination Sequencing Method)" (hereinafter referred to as the "CNV-Seq Detection Kit") of Anno Youda Gene Technology (Beijing)**, an enterprise in Beijing Economic and Technological Development Zone, has been approved by the National Medical Products Administration (NMPA). This is the first detection kit based on next-generation sequencing methodology and prenatal "chromosomal aneuploidy and gene microdeletion" in China.
It is reported that the approval of the CNV-Seq detection kit has filled the gap in prenatal molecular diagnosis in China, especially in the prenatal diagnosis of chromosomal microdeletions. From a functional point of view, Annoland's CNV-Seq test kit can simultaneously detect chromosomal aneuploidy and copy number variation (CNV) in amniotic fluid samples, which is helpful for pregnant women to detect fetal birth defects before childbirth. In addition, the CNV-Seq detection kit has the advantages of wide detection content, high throughput, and short cycle, and the test results can be obtained in about 7 days.
The approval of this product has established a standard for similar products to be approved by regulatory agencies in the future, and has also boosted the industry's confidence in the application of NGS technology in prenatal diagnosis, and marks another key step in the construction of NGS technology in the construction of China's birth defect prevention and control system. The relevant person in charge of Anno Youda said. As a pilot unit for the clinical application of high-throughput gene sequencing by the National Health Commission in 2015, Annoroad has accumulated rich experience in the clinical application of NGS, and will continue to provide professional overall solutions for life science research based on the advantages of multi-omics technology in the future, and closely follow the development trend of the industry to promote the transformation of technological achievements, and contribute to clinical problems such as birth defect prevention and control, tumor gene detection and pathogenic microorganism detection. (Reporter Liang Qian reports from Beijing).
Editor: Yu Jiang.