Interview with Dr. Wanshi Cai : Create an ALL-IN-ONE solution for gene capture made in China
In recent years, with the development of precision medicine and the advent of the era of artificial intelligence, the gene sequencing industry has shown an explosive growth trend, and the application scenarios have also moved from scientific research to clinical and public health consumption, and the market penetration rate has gradually increased. At the same time, startups in the gene sequencing industry have sprung up. However, most start-up companies are mainly concentrated in the middle and lower reaches of the industrial chain, with high requirements for professional skills of practitioners, high thresholds for business development, and there are very few upstream companies that can provide basic technology and equipment in China, and the entire industrial chain faces the pain points of demand without overall solution providers, which restricts the development of the domestic NGS industry chain to a certain extent.
As an upstream supplier, iGeneTech has focused on gene capture technology research and development since its establishment in 2014, customizing and developing gene capture products for different application fields. At present, the product line of iGeneTech has fully covered the upstream, middle and downstream of the gene capture field, and can provide overall solutions for gene capture for the entire industrial chain. So, how does iGeneTech empower China's genetic testing industry chain? What kind of service value will the upgrade and expansion of the overall solution bring to the middle and downstream genetic testing enterprises? With the blessing of national policies, where will the genetic testing industry go? With these questions in mind, Sequencing China interviewed Dr. Cai Wanshi, CEO of iGeneTech, to gain an in-depth understanding of the strategic layout of iGeneTech, and the following is the transcript of the interview.
Source: iGeneTech
Sequencing China: Hello Dr. Cai, can you share what technological innovations iGeneTech has made in the field of gene capture?
Cai Wanshi: iGeneTech is currently the only company in China that has two sets of gene capture technologies: probe hybridization and multiplex PCR. We have applied for more than 20 invention patents around these two sets of technologies, of which 13 have been authorized. We also participated in the formulation of national standards for gene capture.
In terms of probe hybridization technology, the gene capture technology process of iGeneTech is more streamlined than similar technologies in the world. Our TargetSeq One® (Liquid Phase Probe Hybrid Gene Capture Technology) enables single-tube operation, supports rapid hybridization in 2 hours and fewer washes, and is easy and fast to complete library creation capture experiments in one day. In addition, iGeneTech launched a universal blocker product, which can use a blocker to achieve good closure of different indexes, thereby further simplifying the gene capture operation process and obtaining higher capture efficiency. At present, the universal blocker of iGeneTech can dock Illumina's TruSeq, Nextera connector, BGI's single-ended index and double-ended index connector, and 10x Genomics and other single-cell technology specific connectors, which is the most diverse general blocker on the market.
In multiplex PCR, we can achieve PCR reactions of thousands of multiplex per tube, and the two-step method is extremely simple and cost-effective.
In addition, iGeneTech can also provide all-in-one gene capture technology solutions for customers who need gene capture technology. The overall solution includes: gene capture kit customized development, gene capture laboratory LIMS system, whole process automation program, data management and interpretation program, quality management system certification consulting program, gene capture sequencing ultimate cycle plan, etc., to help third-party clinical inspection institutions, hospital precision medicine centers, genetic testing enterprises, scientific research and clinicians to provide full-cycle, automated, intelligent and productized genetic testing ALL-IN-ONE solutions.
Sequencing China: What are the technical indicators of iGeneTech against similar international products? What is the value of this technology to the development of the domestic genetic testing industry?
Cai Wanshi: Thanks to the continuous R&D investment and upgrading iteration of technology in recent years, iGeneTech's gene capture technology has not only been recognized by existing cooperative customers, but also highly praised by international authoritative institutions such as the International MAQC Omics Big Data Quality Control Society. In 2018, in the gene capture technology performance test held by the society, as a Chinese gene capture manufacturer, it competed with Agilent, Roche, IDT, Illumina, Qiagen, and Thermo Fisher. Compared with similar foreign products, the mutation detection rate, false positive rate, sensitivity and other indicators of iGeneTech have comparable performance.
For different application directions, iGeneTech has independently developed a series of standard products, such as China's first human whole exon capture kit. At present, the human whole exon capture kit has been widely used in the genetic diagnosis of rare diseases and genetic diseases, with a cumulative output of more than 4,100 cases of data, and assisted in the publication of more than 7 SCI literature, some of which have been published in top journals such as Nature. Recently, iGeneTech launched the 7-working day quick inspection service of AIExome®, which provides customers with the rapid and cost-effective service where whole process reagents are manufactured in China. In last year's Coronavirus epidemic fight, iGeneTech launched the SARS-CoV-22 Clinical Amplicon Sequencing Kit , which can accurately detect virus mutations and trace the origin of virus transmission, and successfully help tracing of the epidemic in Xinfadi, Beijing. The Center for Disease Control and Prevention, the Institute of Genomics of the Chinese Academy of Sciences, Peking University and other scientific research institutions in China have highly praised the kit. In addition, iGeneTech's HRD, immune group library, HLA, Y-STR, and tumor large panel have also been widely recognized for their excellent technical indicators that are not inferior to similar international products.
To promote NGS genetic testing to people's livelihood applications, gene capture can greatly reduce the cost of sequencing, which is a necessary key technology. iGeneTech broke the foreign monopoly of the technology and allowed Chinese to have its own gene capture technology and national standards. China also has the intellectual property rights and pricing power of gene capture technology. In addition, iGeneTech is also equipped with three sets of full-line technologies for gene capture, namely multiplex PCR, probe hybridization and DNA methylation capture, which can be docked with downstream applications in all fields. At present, iGeneTech has been upgraded to a total solution provider of gene capture technology, which can provide one-stop services for downstream customers and help the independent controllable and explosive development of the domestic NGS genetic testing industry chain.
Sequencing China: Based on the core technology platform, what business sectors has iGeneTech laid out? What types of customers do you primarily serve? What size do you expect the market to look like in the future?
Cai Wanshi: At present, the business of iGeneTech has three major segments, namely gene capture kit customized development, overall solutions, and gene capture technology services. The main customers served are genetic testing enterprises, temporary inspection institutes, tertiary hospitals, university scientific research units, etc. As far as the application of gene capture technology is concerned, it mainly includes tumor companion diagnosis, tumor early screening, genetic disease diagnosis, forensic testing, preimplantation diagnosis, germplasm identification, pathogen identification, etc. From the current market development trend and related industry research reports, the cumulative market size of this field can reach trillions in the future. As an upstream supplier, we will also benefit from the vigorous development of the downstream.
Sequencing China: What is the current development status of the Laboratory Developed Tests (LDT) project of clinical laboratories in domestic hospitals? How does iGeneTech solve the dilemma faced by LDT?
Cai Wanshi: LDT needs to be carried out in a laboratory with medical qualifications, including hospitals and third-party clinical examination centers. First of all, the number and type of LDT carried out by China's third-party temporary inspection institute (ICL) are far from those in Europe and the United States. In European and American, advanced and representative detection methods, such as tumor early screening, tumor large panel accompanying diagnosis, genetics and diagnosis, etc., have been applied to LDT projects on a large scale, and there are more than 5,000 tests available. In contrast, only a few ICLs in China have begun to apply related technologies, and most of them are used as clinical research, with about 500 test items, which cannot meet the increasing individualized and precise needs of clinical diagnosis and treatment.
By the end of 2019, there were more than 1,500 ICLs in China and about 6,500 in the United States. In 2019, ICL accounted for only 5% of China's clinical testing market, the EU 60%, the US 30%, and Japan 60%. It shows that China's ICL industry is in its early stages and has great growth potential. In addition, with the release of national documents for genetic testing of strictly examined clinical specimens, the clinical demand for LDT in hospitals built by themselves or co-built laboratories with ICL has increased significantly. At present, there are more than 1,400 third-grade class-A hospitals in China. This means that in the future, thousands of hospitals in China will need to build gene capture and sequencing laboratories, and there is huge room for development. In addition, the relaxation of relevant policies is also expected to promote the rapid development of ICL.
The all-in-one solution for gene capture launched by iGeneTech can help customers quickly build and carry out NGS genetic testing. This solution not only reduces the business threshold, but also increases the production throughput by 20~50 times, compresses the manual operation time by hundreds of times, and compresses the detection cost by 30%~50%. Relying on this scheme, genetic testing institutions can completely realize domestic substitution, and ensure that the performance indicators are comparable to imported products, fundamentally solving the backward development of domestic LDT.
Sequencing China: For the upstream, middle and downstream of the genetic testing industry chain, how does iGeneTech provide overall solutions for genetic testing? Compared with domestic and foreign manufacturers, how is the competitive situation?
Cai Wanshi: The overall solution of gene capture of iGeneTech is divided into wet experimental process, dry experimental process, and LIMS system. In terms of wet experiment procedures, iGeneTech can provide one-stop sample management, reagents, instruments, consumables, and low-throughput manual processes and high-throughput automated processes. In terms of dry experimental procedures, users can choose to obtain biometric information and report interpretation services on a localized all-in-one machine or an online cloud platform. In terms of LIMS system, we can provide an efficient and intelligent information flow platform, covering the whole cycle from sample entry to project delivery.
After the launch of the overall solution of gene capture, it has the most complete product solution module in the core technology, supporting reagents, supporting hardware, supporting software, technical services and other modules, and has the highest degree of completeness compared with similar foreign enterprises!
Sequencing China: Can you share the future development plan of iGeneTech?
Cai Wanshi: The long-term development plan of iGeneTech can be summarized as a three-step strategy of "reading, writing and editing".
"Read" is gene capture sequencing. Based on the focus on gene capture technology development, iGeneTech has two major roles: overall solution provider and gene capture technology service provider, and has created high barriers to its own technology and company scale, effectively driving the rapid growth of revenue and value. At present, iGeneTech has built a full set of overall solutions from probe hybridization, multiplex PCR, library construction reagents to connector primers, bioinformation analysis report interpretation, automation equipment, and LIMS systems, and all modules are mainly cost-effective Chinese quality manufacturing, so as to improve the domestic NGS genetic testing industry infrastructure, and finally cooperate with industry members to build an industrial supply ecological chain of genetic testing nationwide. In addition, iGeneTech focuses on the continuous iteration of gene capture technology, and has reserved DNA methylation technology with excellent performance, which can achieve accurate detection of DNA methylation level in the target region, and has developed enhancer that can greatly improve the capture efficiency for DNA methylation capture, helping customers reduce sequencing costs and finally enter the tumor early screening market.
"Write" is a high-throughput DNA synthesis based on a chip. iGeneTech has been engaged in the research and development of chip-based high-throughput DNA synthesis technology for more than three years, and has successfully developed the first chip-based DNA high-throughput synthesis technology in China, once again solving a stuck neck technology, laying the foundation for the next stage of "edit", that is, becoming an upstream manufacturer of synthetic biology. In the future, based on this business, we will provide services such as de-novo synthesis of genes/genomes, synthesis for DNA storage, synthesis for antibody drug research and development, etc., and expand a broader market space.
Next, iGeneTech will consolidate and expand the existing gene capture market share, gradually transition to the field of synthetic biology, and in the farther future, enter the field of gene therapy.
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