Health Planning Commission Li Jinming: Policy Orientation and Challenges of China's NGS Diagnostic Testing Technology
Recently, Science released the “Precision Medicine in China†supplement, which explores the development of precision medicine in China, including the related policies and research work of precision medicine, and the current application of precision medicine in disease diagnosis and treatment. Dozens of experts in the field of precision medicine in China participated in the article. The following are the authors of Professor Li Jinming and Dr. Zhang Rui from the Clinical Laboratory Center of the Ministry of Health.
Over the past decade, the rapid development of NGS technology has made DNA sequencing faster and cheaper. NGS technology is now rapidly being used in routine clinical practice, including analysis of solid tumors, hematologic malignancies, genetic diseases and infectious diseases, as well as non-invasive prenatal diagnosis (NIPT), preimplantation genetic diagnosis (PGD) and implantation. Pre-genetic screening (PGS).
Considering the increasing use of NGS technology in the clinic, China's State Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) stopped clinical NGS trials in 2014 and released a series of NGS-specific tests. Regulatory requirements.
CFDA regulation
CFDA requires that all components of the NGS commercial diagnostic system be licensed for clinical use, including reagents, instruments, and software packaged for sale to the laboratory. The first approved diagnostic products of CFDA are BGISEQ-1000 and BGISEQ-100, which are produced by Huada Gene, and diagnostic kits for fetal chromosomal abnormalities (trisomy 21, trisomy 18, trisomy 13). Semiconductor sequencing and join probe-anchor sequencing were used. NIPT has become one of the most widely used NGS tests in China, and several clinical validation studies have confirmed the high sensitivity, specificity, and negative predictive value of NIPT. To date, CFDA has approved five NGS instruments: BGISEQ-100 (based on Life Technologie's Ion Torrent sequencer), BGISEQ-1000 (Complete Genomics-based sequencing technology), and Berry and Kang's NextSeq. CN500, Daan Gene DA8600 (based on Life Technologie's sequencer) and Boao Bio's BioelectronSeq 4000 (based on Life Technologie's sequencer), as well as non-invasive prenatal testing of these instruments. However, commercial NGS products for other clinical fields, such as tumor-related genetic mutations, genetic evaluation, and PGD/PGS, have not been approved for development, and these products are currently in the approval stage.
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