At present, the development of the global NGS sequencing technology still uses the United Kingdom and the United States as the main technology development countries. The United States is dominated by Illumina and Thermo Fisher Scientific, while the UK is based on the Oxford Nanopore technologies (third generation sequencing technology). Mainland China is led by BGI Gene BGI. In addition to its own branded sequencing devices, it also actively lays out the sequencing service market. In Taiwan, there are also physical science and technology focusing on the improvement and R&D of third-generation sequencing technology. In early 2018, Illumina and The iSeq100, a new model launched by Thermo Fisher Scientific, attempts to further reduce the price of sequencing and is more in line with the needs of clinical applications. In addition, the core key component of the iSeq100 (CMOS sensor chip) is created by the Taiwan Chip Design Factory. Phase light design, and by the Power Crystal Group is responsible for OEM key components, this is the first time in Taiwan to enter the global NGS sequencing technology competition.
Since 2016, the FDA has approved a series of NGS-based marketing approvals for in-vitro diagnostic medicines, establishing milestones in the development of NGS technologies for clinical application of IVD, and also fulfilling FDA's commitment to implement genetic diagnostic applications. At the end of 2017, the FDA Approval of Foundation Medicine's companion diagnostic kit, Foundation One CDx, as a companion diagnostic medical material for solid tumor drugs, further establishes the validity of NGS in vitro diagnostic applications.
In the field of clinical application of NGS technology, in addition to being implemented in third-party testing laboratories, there are more and more hospital clinical testing laboratories, incorporating NGS technology into the tools of clinical testing applications. With clinical NGS technology is becoming more and more widely used. The US FDA medical regulations have clearly defined the scope of gene sequencing applications, including laboratory developed test methods (LDTs) and in vitro tests (In Vitro Diagnosis, IVD). Regulatory approach. At present, the regulatory attitudes of NGS in China and Taiwan are close to those of the United States. Laboratory self-built testing methods (LDTs) can be used in clinical laboratories to assist clinical clinicians in disease diagnosis. The clear and regulatory maturity of this series of market environments will make the clinical application of NGS technology develop rapidly in the next few years.
The future development of NGS sequencing application market will focus on the two aspects of clinical sample analysis and application of genetic information after sequencing, and the demand for biological information and medical information that is rigorous and meets clinical application specifications will increase greatly, thus assisting NGS. The front-end sample automated processing platform for technical sequencing, as well as the testing laboratory that meets the quality standards, will also be an important support system for clinical NGS technology applications.