BGI has been actively developing the Next Generation Sequencing (NGS) platform ever since its acquisition of Complete Genomics (CG) in 2013. The BGISEQ-500 system was made public officially at the end of October 2015, and obtained approval from the China Food and Drug Administration (CFDA) for clinical use in October 2016. On the other hand, Hon Hai Group has also announced its collaboration with BGI to provide production assistance for the NGS platform. This anti-cancer alliance certainly will counter-balance the two existing NGS companies, Illumina and Thermo Fisher (was Life Technology).
As Demand for NIFTY Increasing Sharply, Localized Services are Induced in Taiwan
In recent years, Non-Invasive Fetal Trisomy Test (NIFTY) / Non-Invasive Prenatal Test (NIPT) technology has been matured enough, while the clinical need for prenatal screening has also been increased rapidly, most of the obstetrics and gynecology hospitals/clinics have adopted the method, and it has became a standard prenatal screening test for pregnant women. Among all, Taiwan Gene Health has collaborated with BGI since March 2014 to introduce and popularize its NIFTY/NIPT services in Taiwan. Marketing director from Taiwan Gene Health, Kevin Kuo, indicates that as Taiwan Gene Health obtained exclusive authorization of BGI’s technology to establish a NGS lab in Taiwan, it will be able to provide high-quality, high-efficiency localization services in order to fulfill the massive needs of clinical chromosomal gene screening. The NGS platform in the lab is the BGISEQ-500 system developed by BGI specifically for clinical chromosomal/gene screenings.
Since its publicity at the end of 2015, it has accumulated over 112,000 sample tests, while its analysis is based the clinical data from more than 1.7 million NIFTY/NIFTY PLUS cases worldwide; it is the only NGS analysis system in the world that has substantial clinical gene data on Asian. To meet the clinical testing regulations in Taiwan, the lab now has TAF ISO 15189 medical laboratory accreditation, and all the lab technologists are professionally qualified clinical technologists who have been strictly trained and examined through the assessments by the original BGI technologists before they can formally execute any clinical test. The laboratory is also planning to apply for the international accreditation from College of American Pathologists (CAP) for higher standard of self-discipline.
Genetic Testing Leads the Way in The Rising of Precision Medicine
NIFTY/NIPT is currently the most extensive and successful clinical application of NGS, with the global rising trend of precision medicine, the future demand of NGS applications in other field will for sure be vigorous. The product manager, Chia-Chun Hung, from Taiwan Gene Health indicates that Reproductive Medicine/Obstetrics and Oncology are the two most rapidly progress areas of the current global NGS clinical applications.
As the demand for IVF has grown year by year, NGS applications have also grown from the currently popular prenatal screening to pre-pregnancy screening/diagnosis, as an example, the popularization of Preimplantation Genetic Screening (PGS) and Preimplantation Genetic Diagnosis (PGD) will for sure revolutionize the reproductive Medicine field. For oncology applications, it contains hereditary tumor genetic testing, cancer medication evaluation (Companion Genetic Testing/Companion Diagnostics), liquid biopsy (ctDNA, ctRNA, and Exosome). In connecting with this global trend, Taiwan Gene Health has devotedly set these categories as its future objectives.
Assemble the Asia-Pacific Testing Hub by Rooting in Taiwan to Have the Whole Asia in View
Taiwan is located in the central zone of the Asia-Pacific region; it has a particularly favorable geographic position with Japan and South Korea (Northeast Asia) to the north, and the ASEAN 10 countries (Southeast Asia) to the south. Furthermore, it owns mature quality in medicine, testing technology, and service staff members that, Director Kuo points out, if all the superiority conditions of Taiwan can be well employed, then the whole Asia can be in reach, and therefore, can have Taiwan as the Asia-Pacific clinical gene testing hub.
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