NuProbe Global Files IPO Prospectus Highlighting Breakthrough BDA Technology and Strategic Collaborations with Oxford Nanopore and Qiagen
VCBeat has recently learned that NuProbe Global has signed a patent licensing agreement with global sequencing giant Oxford Nanopore Technologies (ONT). Under this agreement, Oxford Nanopore has obtained a global license for NuProbe Global’s BDA (Blocked Displacement Amplification) technology at an undisclosed price.
Furthermore, CarrierGene Biotech has also signed a cooperation agreement with Qiagen, a German molecular diagnostics developer. The two parties will collaborate to develop innovative molecular diagnostic products based on CarrierGene’s BDA technology and Qiagen’s SPE (Single Primer Extension) technology.
It is reported that commercial collaborations between CarrierGene Biotech and several other multinational companies in the genomics industry are also under negotiation.
For a long time, in the field of advanced genetic testing and diagnostics represented by next-generation sequencing (NGS) and gene chips, upstream sequencers and genetic testing reagents have been monopolized by foreign oligopolies such as Illumina, Thermo Fisher, and Agilent. Illumina accounts for nearly 70% of the global sequencer market share. In recent years, the third-generation sequencing platform MinION nanopore sequencer has gained popularity and wide market acceptance; it was also developed by the UK-based Oxford Nanopore Technologies. Although domestic substitution has been basically achieved in core PCR technologies, China’s development of sequencers is still in its infancy. Overall, China’s gene sequencing industry is mainly concentrated in the midstream sequencing services market, with weak bargaining power upstream and even dependence on upstream reagent supplies.
CarrierGene Biotech is a rare domestic player in the gene industry whose patented technologies have been licensed by leading international sequencing companies, which are required to pay licensing fees.
NuProbe was established in October 2019 through the merger of China’s CarrierGene and the U.S.-based NuProbe, focusing on genetic testing for infertility and oncology. NuProbe’s core team includes tenured professors from Harvard University and Rice University, as well as senior executives from leading companies in the genetics industry such as Illumina, Thermo Fisher, WuXi AppTec, and Daan Gene. Mr. Chai Yingshuang, Co-founder and CEO of the company, previously held senior management positions at renowned multinational corporations including Applied Biosystems, Life Technologies, and Thermo Fisher. With over 20 years of successful professional experience and deep market engagement in molecular diagnostics and genetic testing, he possesses extensive expertise in marketing, sales, and management within the genetics industry. The biotech company CellPro Bio, which he co-founded, was successfully listed on the National Equities Exchange and Quotations (NEEQ) in 2016.
Professor Peng Yin, Co-founder and Scientific Advisory Board Advisor, is a tenured professor at Harvard University. He has published over 60 papers in top-tier academic journals including Nature, Science, and Cell, filed more than 50 U.S. patent applications, and been granted over 20 patents. Professor Yu Zhang, Co-founder and Head of the Innovation Center, holds a B.S. in Biology and a Ph.D. in Computational Neuroscience from the California Institute of Technology, completed his postdoctoral fellowship at Harvard Medical School, and serves as a tenured professor of Bioengineering at Rice University. He has published more than 30 academic papers in journals such as Nature and Science, filed 25 technical patent applications, and received 15 patent grants. Dr. Chenyang Shi, another Co-founder, is the former Founding President of Qiagen’s Asia-Pacific region, former President of BayHelix, and a member of the Biotech IPO Advisory Committee of the Hong Kong Stock Exchange. With 25 years of experience in R&D, marketing, and investment management, he currently serves as CEO of Adicon Clinical Laboratories.
It is worth noting that although CarrierGene Biotech is still in its startup phase, it has already engaged the renowned accounting firm KPMG to conduct a comprehensive audit of the company. Mr. Zhu Min, the company’s Vice President of Finance, previously held key national finance positions at Philips and other large multinational corporations for 17 years. “We aim to help CarrierGene Biotech establish a sound accounting system, a comprehensive budget management system, and an internal control system to mitigate operational risks from the early stages,” he said.
In 2016, after leaving Thermo Fisher, Mr. Chai Yingshuang co-founded CarrierGene. At that time, the molecular diagnostics market was already saturated and highly homogeneous in hot sectors such as infectious diseases and oncology, while few companies had ventured into the field of infertility. “The Chinese infertility market holds immense potential, yet there is a lack of rapid and precise diagnostic methods. Although viable solutions such as pharmacological treatment, surgery, and assisted reproductive technology are available, the causes of infertility are extremely complex. Without a clear diagnosis of the underlying cause, subsequent treatment lacks direction. This inadequacy has left many patients in the predicament of seeking medical advice from multiple sources for extended periods, thereby delaying family planning,” stated Mr. Chai Yingshuang. Based on this insight, CarrierGene positioned itself to start with the development of molecular diagnostic products for infertility and secured a strategic partnership with industry giant Illumina in this field.
On the other hand, the CarrierGene team is also closely monitoring the tumor molecular diagnostics market, continuously developing innovative platform technologies with the aim of launching differentiated tumor molecular diagnostic products. In 2017, CarrierGene obtained Certified Service Provider (CSP) certification for targeted capture high-throughput sequencing from Agilent Technologies in the United States, becoming the second company in China and the 19th globally to achieve this CSP certification. The company has independently developed multiple core technologies, among which its RapidCap NGS targeted capture enrichment technology requires no additional equipment and reduces the library preparation time for target gene capture and enrichment from three days to seven hours. The company’s core algorithm engine, VarDict, was recognized by Nature as the best clinical genetic diagnostic algorithm.
“Upon learning about NuProbe’s innovative BDA platform technology, we keenly recognized its market advantages, particularly its application prospects in the field of oncology,” recalled Mr. Chai Yingshuang. Dr. Chen Yundi, Co-founder and VP of Scientific Services at CarrierGene, also expressed strong confidence in NuProbe: “In the early stages of our business, CarrierGene engaged in deep strategic thinking and precisely targeted the vast, overlooked blue ocean of infertility, thereby establishing a solid market foundation. The current integration with NuProbe’s BDA technology will enable us to comprehensively expand our business into molecular diagnostics for oncology and infectious diseases.” After multiple rounds of communication and negotiation, CarrierGene and NuProbe officially merged.
“This merger is a win-win decision,” said Mr. Chai Yingshuang. “NuProbe’s BDA technology has significantly strengthened our technological barriers in the infertility market.” Professor Yin Peng, co-founder of NuProbe, told VCBeat, “CarrierGene possesses robust market operational capabilities, and our teams are highly complementary. We believe the merger will bring more, faster, and higher-value commercial opportunities for innovative technologies.”
Following the merger, NuProbe’s technical team is distributed across China and the United States, with innovation R&D centers in Shanghai and Houston, and a GMP manufacturing center in Suzhou Industrial Park. NuProbe possesses a revolutionary, independently developed technology platform, with a product pipeline covering integrated molecular diagnostic solutions for oncology, genetic disorders, infectious diseases, and infertility. Dr. Luo Junfeng, Co-founder and VP of Technology R&D at NuProbe, stated, “Collaboration between our Chinese and U.S. teams enables NuProbe to maintain strategic vision while executing with precision. Although based in two different countries, our teams work in close synergy, complementing each other. The U.S. team focuses its energy and ingenuity on pioneering original technologies, while the China team, driven by market demands, ensures effective product commercialization. For urgent and major projects, both teams pursue different technical approaches in parallel. This unique combined strength allows us to achieve R&D breakthroughs and advance project implementation faster than our competitors.”
The BDA technology was jointly developed by Professor Yin Peng and Professor Zhang Yu, the founders of NuProbe. “BDA technology is currently the only technique capable of enriching mutant alleles through multiplex detection. It is also the only selective enrichment technology that has been practically validated on the Nanopore third-generation sequencing platform. As a disruptive foundational technology, it can be widely applied across various molecular diagnostic platforms, including PCR, first-generation capillary sequencing, second-generation high-throughput sequencing, third-generation single-molecule sequencing, and nucleic acid mass spectrometry. Since nearly all molecular diagnostic platforms rely on PCR amplification as their underlying mechanism, BDA enables differential amplification of wild-type and mutant sequences within this framework. By enriching for mutations, it significantly enhances the sensitivity of genetic testing,” explained Professor Zhang Yu.
This enrichment of low-frequency mutations can reduce the required sequencing data volume by more than 40-fold, significantly lowering the cost of clinical genetic testing. It empowers small-scale NGS sequencers, including desktop instruments such as MiSeq and PGM, to perform assays that previously required large-scale, industrial-grade sequencing platforms like NovaSeq—such as large-panel gene testing and tumor liquid biopsy. This reduces the overall operational costs for clinical customers, thereby driving further growth in the NGS market.
In addition to BDA, the company’s Toehold technology can also reduce the sequencing depth required for probe-capture methods by an order of magnitude. Furthermore, CarrierGene Biotech has independently developed a highly efficient method for ligating Unique Molecular Identifiers (UMIs), enabling high-resolution detection of copy number variations (CNVs) in samples with high heterogeneity, such as tumor tissues and cell-free DNA (cfDNA), with a limit of detection as low as a 2.05-fold difference in copy number. Another recent patented technology from CarrierGene Biotech, LDA, effectively ligates short DNA fragments, increasing the effective sequencing throughput of Oxford Nanopore by 10-fold, making it suitable for tumor detection applications.
ONT’s third-generation sequencing platform, the MinION nanopore sequencer, has gained increasing popularity in recent years. The number of DNA molecules that can pass through protein pores on each ONT flow cell is fixed; therefore, longer template DNA molecules are required to increase sequencing throughput. CarrierGene Biotech’s LDA technology precisely meets this fundamental requirement of third-generation sequencing platforms. On the other hand, BDA technology can amplify and enrich low-frequency genetic variants present at levels as low as 0.1% by 500-fold. By improving the signal-to-noise ratio, it helps ONT overcome its longstanding limitation of high error rates. The combination of BDA and LDA not only empowers ONT to expand into liquid biopsy applications but also provides the tumor liquid biopsy market with powerful tools for rapid detection and long-read sequencing, inevitably driving further explosive growth in this booming market.
By integrating BDA with Sanger sequencing, the sensitivity of Sanger-based detection can be improved from the previous 10% to 0.1%, thereby enabling Sanger sequencing to be used for tumor liquid biopsy. With thousands of Sanger sequencers installed in Chinese hospitals, this low-cost tumor liquid biopsy technology undoubtedly holds significant social and economic value.
In addition to international giants, many well-known domestic companies have also signed agreements with CarrierGene Biotech to adopt its technology for developing tumor NGS testing products.
BDA technology’s superior capability to differentially amplify, enrich, and detect mutant alleles can reduce the testing costs for clinical NGS users to a fraction of their original levels, while also significantly lowering instrument and time costs. This empowers small-scale NGS instruments, widely purchased by hospitals, to perform clinical tests that were previously feasible only with a limited number of large-scale NGS sequencers, at the same or lower cost. It enables more affordable Sanger sequencing and qPCR platforms to achieve sensitivity equivalent to digital PCR, and facilitates the entry of third-generation Nanopore sequencing platforms into the oncology market. By making in-house NGS testing a truly accessible reality, this technology is poised to bring about a transformative shift in the landscape of the tumor testing market.
According to Ouyang Hu, VP of Production and Quality, CarrierGene Biotech has launched a range of molecular diagnostic products for infertility, such as JingYue.TMMale Infertility Genetic Testing, YiyueTMFemale Infertility Genetic Testing, ZiyueTMGenetic Testing for Recurrent Pregnancy Loss and JiayueTMPreconception genetic screening for hereditary diseases, among others. The company boasts a robust pipeline of diagnostic reagents under development, covering areas such as oncology diagnostics, infertility, and genetic disorders, with several products already having entered the registration phase.
In addition, BDA-enabled kits for qPCR, Sanger sequencing, nucleic acid mass spectrometry, NGS, and other genetic testing platforms are about to be launched on the market and go on sale.
Beyond teams, technology, and products, CarrierGene Biotech also places significant emphasis on services across all supporting functions. “We have a comprehensive team providing support services for genetic testing reports, encompassing R&D, research laboratories, bioinformatics data analysis, genetic counseling, medical interpretation, market technical support, and sales services, ensuring high levels of customer satisfaction,” emphasized Mr. Zhou Yu, Vice President of Sales at CarrierGene Biotech.
From the perspective of business layout, CarrierGene Biotech adopts a “product + service” model to establish a multi-dimensional market presence through extensive strategic collaborations on experimental platform technologies, sales of mature in vitro diagnostic (IVD) products, and provision of third-party clinical testing services. By developing proprietary genetic testing and analysis technologies, the company effectively connects upstream instrument and reagent suppliers with downstream testing service providers and medical institutions, achieving integration across technology, market, and finance. This comprehensively empowers end customers to implement gene testing capabilities within their own laboratories. “Our technology will drive the integration of genetic testing with broader clinical applications, bringing high-throughput sequencing to hospitals below the Tier 3 Grade A level,” pointed out Mr. Gao Song, Vice President of Marketing and Technical Support.
CarrierGene Biotech has established two business models in the U.S. market. “Strategic collaborations with leading international industry players through licensing and transfer, along with providing off-the-shelf products (VarTrace) and customized testing services (NGSure) to distributors and our internal team, have made this business segment our cash cow,” said Mr. Li Yang, Vice President of Channel and Business Development at CarrierGene Biotech.
For other overseas markets, CarrierGene Biotech tailors its commercial strategies to different regions and countries based on local conditions. For example, it employs an OEM model that allows local partners to complete local registration and promote products through hospitals or clinical laboratories, or enters local markets via traditional distribution channels. CarrierGene Biotech is also seeking global strategic partners to jointly develop markets.
Currently, CarrierGene Biotech is collaborating with MD Anderson (melanoma, ovarian cancer), Yale School of Medicine (lung cancer), and Baylor College of Medicine (genetic disorders) to apply BDA technology for prognostic assessment, risk management, and recurrence monitoring in cancer patients.