Qitian Gene Biotech Advances Isothermal Nucleic Acid Testing Platform with Focus on Medical Diagnostics Following G20 Summit Success

Have you ever visited the quarantine checkpoints at airports? Here, fully loaded containers must be cleared rapidly, yet they are also subject to precise and comprehensive epidemic prevention inspections. To improve throughput efficiency, it is essential to reduce the time required for random sampling inspections. However, ensuring inspection quality while facilitating rapid customs clearance imposes higher demands on detection technologies.

This company provides technical support for such public health services, offering rapid, accurate, and convenient testing technologies that played a crucial role in supporting quarantine operations at ports during the G20 Hangzhou Summit. In early 2018, the company secured tens of millions of yuan in financing from Xieli Investment, with the capital injection driving its rapid growth.

The company’s founder is Wang Zhihong. With a background in management, she originally worked in a field entirely unrelated to healthcare.

Wang Zhihong, Founder of Qitian Gene

Her previous work primarily involved introducing foreign technologies or providing consulting services for large-scale projects.

“Our primary clients are enterprises like Hyundai Group, with each project cycle lasting around three to four years,” she recalled.

Such an extended period allows her to gain a deeper understanding of each project and develop a more mature perspective on technology.

Yet even so, the successive turnover of projects left her feeling that she had not left much of a legacy in the process. She hopes to identify a technology that can be sustained over the long term and translated into practical applications.

With such an intention in mind, she had been waiting for just such an opportunity.

However, Qitian Genomics was not the first company she co-founded. In 2008, she became involved with a pharmaceutical enterprise primarily engaged in the research and development of Class I novel biologics for the treatment of HIV/AIDS and lung cancer.

This project was initiated by Mr. Sun, the former Chairman of Beichen Group. At that time, five out of the eight senior executives at Beichen Group were unfortunately diagnosed with cancer. Perhaps driven by empathy, they decided to develop new drugs effective against cancer through this project.

“I am honored to have joined the team,” said Wang Zhihong, reflecting on the previous project.

However, as is well known, new drug development is no easy task, and they encountered numerous difficulties in the process. Some of these challenges stemmed from protein production during drug development, while others were related to funding.

“Developing new drugs requires substantial capital; at the time, we also invested tens of millions,” she recalled. “Unfortunately, our funding chain eventually broke.”

Although the project ultimately ended in failure, Wang Zhihong gained her first experience of participating in the entire operational process of a project. At the same time, she also recognized the distinct differences between healthcare entrepreneurship and other industries.

“Later, when I continued discussing this matter with some returnees in the medical field, they believed that testing, especially molecular diagnostics, would be the future trend,” Wang Zhihong told VCBeat, noting that overseas markets were also in their early stages at the time.

In 2008, China’s molecular diagnostics sector had not yet evolved into the highly competitive landscape seen today, but foreign companies had already begun to specialize in niche areas. After conducting market research, Wang Zhihong decided to avoid the fiercely competitive testing segment and instead enter the field through upstream raw material research.

In the previous project, Wang Zhihong frequently engaged with various research institutes, thereby laying the foundation for the Qitian Gene team. They aim to leverage their technical expertise and experience in molecular diagnostics and protein production to achieve technological translation and tangible outcomes on their platform.

Qitian Gene’s core technology is called RAA (Recombinase-Aided Amplification) isothermal nucleic acid amplification technology. The company primarily leverages this technology to develop diagnostic kits and instruments for the field of molecular diagnostics.

Typically, nucleic acid amplification requires reaction cycles involving high-temperature denaturation, low-temperature annealing, and optimal-temperature extension. This process usually takes 1–2 hours and necessitates the use of precision instruments.

RAA isothermal nucleic acid technology enables nucleic acid amplification at ambient temperature, shortening the amplification process to 5–20 minutes. The reagents can also be stored and transported for short periods under ambient conditions, facilitating testing in primary care settings and for military counterterrorism purposes. Furthermore, with this technology, the entire process from amplification to detection can be performed at ambient temperature.

“Quarantine ports and similar locations are unsuitable for deploying large, sophisticated instruments, nor is there ample time to wait,” Wang Zhihong told VCBeat. “Our technology can operate at temperatures in the 30s (°C) and features straightforward operation, which constitutes our competitive advantage.”

Currently, its products are primarily targeted at five major sectors: public health (inspection and quarantine at airport ports, Centers for Disease Control and Prevention, food safety, etc.), healthcare (hospitals, community medical services, etc.), scientific research (colleges and universities, academic and research institutions, enterprises, etc.), public security (epidemic prevention and control, military biochemical defense, etc.), and ecological environment (GMO testing, species identification, environmental microbiology, etc.).

Among these, the two core sectors are public health and medical applications.

“We are currently expanding our presence in the fields of public health and food safety,” revealed Wang Zhihong. Due to its rapidity, sensitivity, and ease of operation, isothermal nucleic acid technology offers significant advantages in the public health sector.

This also enabled them to successfully secure the tender project for inspection and quarantine at the airport port during the Hangzhou G20 Summit. Meanwhile, they have established collaborations with institutions such as the National Institute for Viral Disease Control and Prevention under the Chinese CDC, the Jiangsu CDC, other centers for disease control and prevention across China, inspection and quarantine authorities in Zhejiang, Guangdong, and Dalian, the Academy of Military Medical Sciences, and the Chinese Academy of Inspection and Quarantine.

“This is our specialty, with a focus on the field of public health,” said Wang Zhihong.

In 2017, Qitian Gene, as the sub-project lead unit, was awarded a project under the “Research and Development and Industrialization of Novel Tuberculosis Diagnostic Products” initiative, which was part of the National Major Science and Technology Project for the Control and Prevention of Major Infectious Diseases during China’s 13th Five-Year Plan period. In 2018, Qitian Gene once again received approval under the National 13th Five-Year Plan Major Special Project, this time for the project titled “Development and Industrialization of Rapid Diagnostic Reagents for Sixteen Major Infectious Diseases Targeting Primary Care Hospitals.” Notably, BGI Genomics, the leading company in next-generation sequencing, served as the consortium leader for this project, with Qitian Gene continuing to participate as a task-performing unit.

All of this signifies national-level recognition of the company and its technology.

From 2017 to 2018, a total of seven projects from Qitian Gene were approved under the “13th Five-Year National Science and Technology Major Project for Infectious Disease Prevention and Control.”

Given the current macro environment in China, testing processes cannot remain confined to hospitals; instead, they must be outsourced to third-party platforms. Wang Zhihong believes that the advantages of such platforms should stem from two aspects: technology and cost.

Technically, the primary considerations are whether the testing process is easy to operate and whether the results are accurate. Qitian Gene’s RAA isothermal nucleic acid technology enables nucleic acid amplification, storage, transportation, and detection at ambient temperature, allowing for point-of-care testing without the need for large-scale instruments. More importantly, the detection time has been reduced by fourfold compared to previous methods.

Cost-effectiveness manifests more directly, and cost advantages can trigger a ripple effect. For instance, second- and third-generation sequencing technologies have achieved a qualitative leap in cost reduction compared to Sanger sequencing. This has enabled gene sequencing to transition from scientific research into everyday life.

“By leveraging my technology, the high throughput and extended detection windows can reduce costs by 20%–30%,” said Wang Zhihong. “This cost reduction will enable us to make the product accessible to a broader user base.”

In terms of sales, like many other companies, Qitian Genetics has adopted a dual model combining direct sales and agency distribution.

“These two models coexist, but direct sales account for a larger share,” Wang Zhihong revealed. “As a startup, we have limited presence on agency platforms.”

She believes that the sales model should be aligned with the company’s stage of development. In her view, during the first three years of sales, the market requires more interpretation and support to understand the technology, and her own understanding of the product is certainly superior to that of distributors.

After three years, the market will gradually mature, and communication with distributors will become more seamless. Once production capacity scales up accordingly, it will still be necessary to leverage distribution channels to expand market share.

“I believe this is an ideal sales model,” stated Wang Zhihong. It is understood that the company will primarily rely on direct sales over the next three years or so.

On June 26, 2017, Qitian Gene completed the construction of its GMP-compliant production workshop, marking the initial completion of the company’s industrialization.

In early 2018, Qitian Genomics secured Series A financing from XieLi Capital. Zhai Gang of XieLi Capital noted that, as a next-generation molecular diagnostic technology, Qitian’s proprietary RAA (Recombinase Aided Amplification) isothermal amplification technology holds promise for broad application in clinical diagnostics, inspection and quarantine, species identification, food safety, and other fields. Qitian Genomics has established complete, large-scale production capabilities across the entire value chain—from upstream enzymes and protein raw materials to lyophilized reagents and detection instruments—giving it significant competitive advantages in quality control and cost efficiency. The company is well-positioned to become a leading enterprise in the field of isothermal amplification-based molecular testing.

Wang Zhihong revealed that Qitian Genomics positions itself as a modular supplier for testing service platforms. The company has now achieved full upstream coverage, spanning from instruments and equipment to consumables. Following this round of financing, they will further complete the construction of their industrialization base, thereby breaking through the ceiling on industrial scale.

It is reported that the company has already had 10 invention patents approved. Moving forward, it will continue to build a technology platform with independent intellectual property rights and complete the entire industry chain from raw materials to finished products.

“We will also engage in discussions with relevant departments in the public health sector to ultimately establish industry standards and drive industry development,” Wang Zhihong told VCBeat.

In addition, Qitian Gene has initiated the registration and filing process for its Class III medical device products. Wang Zhihong revealed that the healthcare sector will be a key business segment in the near future.