IVD tests are medical devices used to diagnose, monitor, screen and assess predispositions to diseases from assays in a test tube or in a controlled environment outside an organism, contributing to the available medical information of a patient. Molecular diagnosis, as one of the fastest growing segments in IVD, especially during the COVID-19 period, refers to the assessment of a person's health at a molecular level through the detection and measurement of specific genetic si
BGI Genomics
Founded in 1999, BGI Genomics (Chinese: 华大基因) is the world's leading one of the world's leading genomics test and research service providers, providing genomics test and research services for medical institutions, research institutions, enterprises and institutions through genetic testing and other means. Relying on cutting edge bioinformatics pipelines, advanced R&D, high-performance proprietary NGS sequencing technology, mass spectrometers,and underpinned by a decade of commercial experience, BGI Genomics provides its customers with expert and affordable clinical molecular diagnostic solutions and NGS services for research. The recently lanuched DNBseq™ sequencing technology combines the power of DNA Nanoballs (DNB™), PCR-free Rolling Circle Replication, Patterned Nano Arrays and cPAS to deliver a new level of data clarity and affordability. Now BGI has operated businesses in more than 100 countries and regions around the world. On July 14, 2017, BGI Genomics was officially listed and became the 2001st listed company of the Shenzhen Stock Exchange.
Berry Genomics
Founded in 2010, Berry Genomics (Chinese: 贝瑞基因) is a leading company in clinical genomics and life science in China, dedicated to R&D and commercialization of genetic test technologies in clinical applications. With strong R&D capability, Berry Genomics pioneered the first NGS-based genetic test, NIPT, in China back in 2010. In 2015, Berry Genomics’ sequencer, NextSeq CN500, and its NIPT reagent obtained IVD license from NMPA, which was among the first batch of licenses of its kind in China. In 2019, NextSeq CN500 got NMPA’s official approval to extend its clinical testing scope from NIPT only to multi-human diseases including genetic diseases and cancers. Berry Genomics is now exploring the use of third-generation sequencing technology in both clinical field and scientific study. To date, Berry Genomics has provided services for over 4000 organizations and facilities home and abroad, including hospitals, research institutions, universities and corporations.
DaAn Gene
Founded in 1993, DaAn Gene (Chinese: 达安基因) is a leading medical diagnostic company engaged in the discovery, development, manufacturing and marketing of a broad range of innovative products for clinical diagnosis, health management and other fields. DaAn's product line contains over 100 NMPA and 50 CE marked products based on real-time PCR technology, molecular hybridization and sanger sequence, including real-time PCR diagnostic kits and instruments, automatic nucleic acid extraction, immunoassay kits, pathology products and so on. With more than 20 years in the molecular diagnostic industry, its comprehensive molecular diagnosis solution covers the entire disease screening process, from sampling and nucleic acid extraction through PCR preparation and amplification to diagnostic reports. It is also one of the few domestic companies which have formed a self-developed, complete industry chain platform of world-class IVD products. Now the company has served customers in more than 140 countries through subsidiaries and strong distribution networks.
Sansure Biotech
Sansure Biotech (Chinese: 圣湘生物) is an IVD solution provider integrating diagnostic reagents, instruments and independent clinic laboratory services with its own innovative gene technology as its core. Headquartered in Changsha, the company has built the new Industrial Park in Shanghai to create a production base for precise and intelligent molecular diagnostic systems and an important international hub, and set up branches or affiliates in nearly 20 cities, including Beijing, Guangzhou, Chongqing and Xi'an. Sansure has developed a series of internationally leading core technologies and more than 500 products with performance exceeding the advanced level at home and abroad. In 2010, it developed the world's leading fast and simple One-tube Fast Release Technology and in 2016, it launched global leading Universal Automatic Nucleic Acid Extraction System. All the new technologies and products have led the domestic industry to catch up with the international advanced level, and is now breaking the monopoly of imports.
Coyote Bioscience
Founded in 2009, Coyote Bioscience (Chinese: 卡尤迪生物) is an innovator dedicated to developing point-of-care testing (POCT) solutions and fully automated, integrated rapid molecular diagnostic systems. Headquartered in Beijing, the company has also built R&D centers in Beijing and Silicon Valley. It possesses 95 patents including international patent technology of "Molecular In-Parallel Reaction". With continuous breakthroughs in rapid PCR tests, Coyote has been providing technical solutions for epidemics around the globe. During COVID-19 period, it launched the proprietary FlashDetect™ products for COVID-19 testing and it is internationally patented. Featuring testing at anytime and anywhere with results available in a short time, The FlashDetect™ products can perform efficient testing in target areas, symbolizing that China has taken the lead in PCR testing worldwide. Now Coyote Bioscience has served more than 1800 hospitals in China, and provided products for more than 70 countries and regions.
Bioer Technology
Founded in 2002, Bioer Technology (Chinese: 博日科技) is a leading supplier of life science and medical diagnostic products in China, specializing in the R&D, manufacture and sales of molecular detection serial products. As one of the leaders in domestic PCR industry and obtained the 1st registration certificate of China quantitative fluorescent PCR detection system, Bioer has developed into acomprehensive supplier of molecular detection with multiple technology platforms product lines. The main products include real-time fluorescence quantitative PCR instruments, automatic nucleic acid purification instrument, thermal cycler, nucleic acid purification reagent, all kinds of PCR detection reagents, standard PCR laboratory, mobile PCR laboratory, sample preservative fluid, molecular detection consumables and PCR raw materials. It creates the whole industry PCR chain business model of "Instrument + Reagent +Consumables + Molecular raw materials". To date, Bioer's business covers more than 120 countries and regions.
Orient Gene
Founded in 2005, Orient Gene (Chinese: 东方生物) is a company specializing in the R&D, production and sales of IVD products, belonging to the field of high-end medical equipment and devices. The main products are POCT instant diagnostic reagents, which are mainly used in the detection of infectious diseases (including COVID-19 detection products), drugs of abuse, fertility, tumor marker and cardiac marker detection, among which infectious disease and drugs of abuse detection are the two core product series of the company. Besides, Orient Gene continues to invest in the R&D of biological raw material platform, molecular diagnostic platform, liquid biochip platform and IVD instrument platform, and formulates the strategy of synchronous development of each technology platform. At present, the company has obtained more than 300 overseas certifications, and more than 70 domestic registration certificates. Now its sales network has been extended to more than 120 countries and regions.
AmoyDx
Founded in 2008, AmoyDx (Chinese: 艾德生物) is an R&D based diagnostic company, focusing on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights of ADx-ARMsR，Super-ARMsR,ddCaptureR and ADx-HANDLERtechnologies，AmoyDx has a market-leading portfolio of moleculardiagnostic assays. Based on multiple technology platforms including PCR, NGS, FISH and lHC, AmoyDx's coreproduct categories include single gene testing kits, multi-gene testing panels, NGS panels and NGSanalytical systems. In the past years, more than 20 diagnostic kits have been approved by the Chinese authorities, the NMPA and in Europe. AmoyDx has also partnered with famous pharmaceuticals such as AstraZeneca, Johnson & Johnson, Amgen, and Eli Lilly, providing diagnostic products and services for trials of drugs in clinical development and for clinical practice. Now, it serves an extensive domestic and international oncology network, reaching over 500 hospitals in China and over 50 countries worldwide.
Burning Rock Dx
Founded in 2014, Burning Rock Dx (Chinese: 燃石医学) is a leading IVD company focusing on the application of next generation sequencing (NGS) technology in the field of precision oncology. The main products include liquid biopsy test, large oncopanel tissue kit, multi-cancer early detection kit and so on. In its operated 3 labs, A CLIA / CAP/ISO 15189 lab in Guangzhou has NGS and IHC capability, a CLIA/CAP lab in Irvine, CA has NGS, IHC, and R&D capability, and a lab in Shanghai has R&D and NGS capability. In 2020, Burning Rock Dx became the first Chinese NGS cancer detection company listed on NASDAQ. To date, its OverC multi-cancer detection blood test (MCDBT) has received Breakthrough Device Designation from the US FDA and CE certificate from the EU. Three cancer test kits have received a CE certificate and in 2018, the first NGS-based cancer detection kit was marketed.
Creative Biosciences
Founded in 2015, Creative Biosciences (Chinese: 康立明生物) is a molecular diagnostic company dedicated to making breakthroughs in early diagnosis, early intervention, and prognosis monitoring of chronicle diseases specifically in cancer. The core product, Colosafe, can precisely detect and interpret the mutated messages (human SDC2 methylation) from stool for detection of colorectal cancer to help physicians to figure out the cancerous lesion early and prevent the development of CRC at early stage. It is the first NMPA approved stool DNA test kit for colorectal cancer and has been implemented in over 700 hospitals in China. As for the overseas market, Colosafe has already received sales permits in the EU and approval from Thailand's Food and Drug Administration. Middle East and North Afria regions are also targeted markets. Apart from Colosafe, other noninvasive early detection kits for lung, bladder, cervical, liver cancers, together with POCT products have reached amazing development as well.