Daan Gene Secures Approval for Two New Nucleic Acid Testing Kits, Achieving Full-Cycle PCR Industry Integration

DaAn Gene was listed on the Shenzhen Stock Exchange in August 2004, becoming the first publicly traded company among university-run enterprises in Guangdong Province. For over two decades, the company has focused on the development and application of fluorescent PCR diagnostic reagents. It is a state-owned biomedical enterprise integrating the R&D, production, and sales of clinical diagnostic reagents and instruments, as well as providing clinical laboratory testing services through its nationwide chain of independent medical laboratories.

During the COVID-19 pandemic, which affected the entire globe, DaAn Gene performed exceptionally well. It developed a nucleic acid test kit for the novel coronavirus in just 48 hours, becoming one of the first two manufacturers in China to release specifically targeted nucleic acid testing reagents.

Following the initial centralized procurement of COVID-19 testing reagents in Hubei Province, DaAn Gene successfully won all bids in subsequent centralized procurement programs in Hubei, Heilongjiang, Fujian, Guizhou, and Guangdong provinces, as well as within the military system. It became the only company in China to secure all bids for centralized procurement of COVID-19 nucleic acid testing reagents.

The "2020 China POCT Annual Conference," hosted by the Point-of-Care Testing (POCT) Branch of the China Association for Medical Devices Industry and the People's Government of Jiangbei District, Chongqing Municipality, was grandly held at the Century Jinyuan Grand Hotel in Chongqing on November 13–14, 2020. Under the slogan "Beidou + 5G: Building the Dream of China's POCT" and themed "Precise Epidemic Control and Health for All," the conference featured a plenary session, thirteen academic sub-forums, and exhibitions of corporate products.

At the corporate product exhibition area, DaAn Gene attracted significant attention from attendees with its two novel coronavirus nucleic acid testing kits and several compact, portable AGS8830 real-time fluorescence quantitative PCR instruments. To gain deeper insights into DaAn Gene’s strategic layout in the niche sector of nucleic acid testing and the substantial value demonstrated by such testing during the COVID-19 pandemic, VCBeat conducted an exclusive interview with Dr. Jiang Xiwen, Dean of the DaAn Gene Research Institute.

In response to the current outbreak, DaAn Gene has developed two novel coronavirus nucleic acid detection kits: the Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescent PCR Method) – Standard Reagent, and the Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescent PCR Method) – Rapid Reagent. Both kits are compatible with various nucleic acid detection instruments.

Novel Coronavirus Nucleic Acid Detection Kit (Fluorescent PCR Method): The standard reagents adopt a “dual-target + internal control” design, which can effectively monitor the occurrence of false-negative results in nucleic acid testing. The assay features rapid detection, high sensitivity, and no cross-reactivity.

According to Director Jiang, this nucleic acid testing reagent has a detection time of approximately 110 minutes and an analytical sensitivity of 500 copies/mL. It does not exhibit cross-reactivity when detecting pathogens that infect the same site or cause similar symptoms, such as coronaviruses OC43, NL63, 229E, and HKU1, parainfluenza viruses, influenza A and B viruses, respiratory syncytial virus, and adenovirus.

Another novel coronavirus nucleic acid detection kit is also based on fluorescent PCR technology and belongs to the dual-gene detection type (ORF1ab and N genes); the single-tube, single-sample specification adopted by this product eliminates the need for complex system preparation, allowing direct addition of nucleic acid for detection. The entire testing process can be completed in as little as half an hour, effectively improving the efficiency of novel coronavirus testing.

When used with its dedicated instrument, this kit can significantly reduce testing costs and save labor and time. Director Jiang stated that the kit can process samples for 10,000 individuals within 8 hours, enabling rapid high-throughput testing even when equipment, manpower, and time are limited. This capability effectively alleviates the current pressure caused by insufficient testing capacity and allows for broad application in clinical settings, Centers for Disease Control and Prevention (CDC), and customs inspection and quarantine.

Compared with nucleic acid detection reagents, DaAn Gene’s latest real-time quantitative PCR instrument, the AGS8830, has attracted significant attention from attendees. This compact and lightweight device features rapid processing, high throughput, ease of operation, and portability. The AGS8830 can complete the entire process from sample collection to result reporting within one hour, with a minimum turnaround time of just 35 minutes, and supports a maximum sample throughput of 16.

Leveraging unique real-time dynamic precision temperature control technology and advanced semiconductor thermoelectric coolers, the AGS8830 achieves a maximum heating rate of 8°C/s. Combined with its proprietary scanning method and newly designed hardware and software, it significantly reduces experimental reaction cycle times.

Compared with similar rapid nucleic acid testing systems, the AGS8830 offers significant advantages in sample throughput. While most rapid nucleic acid testing instruments currently on the market have a throughput of 1, the AGS8830 provides options for 8- and 16-sample throughput. This design ensures flexibility and convenience, delivers higher reporting efficiency than traditional PCR methods, and minimizes the cost per single-sample test.

Since the accompanying reagent kit is packaged in single-tube, single-test formats, users do not need to prepare reaction systems; they can directly add sample nucleic acids for PCR amplification, thereby simplifying the operational workflow. With its compact size, lightweight design, and large touchscreen interface, the AGS8830 enables rapid completion of various human-machine interactions, such as sample information entry and experimental analysis, typically performed on conventional PCR amplification analyzers.

It is worth noting that DaAn Gene’s nucleic acid detection reagents incorporate UDG enzyme to prevent false positives caused by amplicon contamination; meanwhile, an endogenous internal control monitors the sampling and PCR amplification processes, effectively preventing false negatives resulting from improper sampling operations or abnormalities in the reaction system. Additionally, the inclusion of negative and positive controls further helps prevent the occurrence of false-positive or false-negative results.

Currently, the National Medical Products Administration (NMPA) has approved 17 novel coronavirus nucleic acid detection kits based on fluorescent PCR technology. Compared with its peers, DaAn Gene’s competitive advantage lies in its self-sufficiency in core raw materials, eliminating reliance on external suppliers, and its integration of the entire nucleic acid testing industry chain, encompassing R&D and manufacturing, core raw materials, quality control materials, instrument R&D and manufacturing, and testing services.

President Jiang stated, “Amid the still-severe epidemic situation, manufacturers have high demand for various raw materials, with many facing price increases. However, DaAn Gene achieves in-house production from the source, which not only shields it from disruptions in raw material prices or supply volumes but also enables unified quality control. This ensures both high cost-effectiveness and guaranteed quality.”

On July 2, 2020, the State Council issued the "Notice on Further Accelerating the Enhancement of Nucleic Acid Testing Capacity for Novel Coronavirus in Medical Institutions," which stated:

“Standardization and timeliness of nucleic acid testing must be improved. For patients in fever clinics, nucleic acid test results should be reported within 6 hours, with an aim to shorten the turnaround time to 4 hours; for general outpatient and emergency patients, hospitalized patients, and accompanying caregivers, results should原则上 be reported within 12 hours; for individuals undergoing voluntary testing under the ‘test all who wish to be tested’ policy, results are generally reported within 24 hours.” This indicates that pandemic prevention and control efforts have imposed stricter requirements on the timeliness of nucleic acid testing.

Dean Jiang stated that, in terms of future development trends, desktop or large-scale nucleic acid testing instruments will evolve toward portable and handheld formats; traditional large-scale laboratory testing, which is labor- and resource-intensive and constrained by location, will transition toward point-of-care testing and mobile testing. In terms of application areas, the use of nucleic acid testing is not limited to medical diagnosis but will gradually expand into fields such as environmental monitoring and food safety.

From the perspective of production capacity, there is substantial surplus in the domestic production capacity of nucleic acid testing reagents. However, Dean Jiang stated that there is currently no need to worry about overcapacity in nucleic acid testing kits.

First, the overseas epidemic has not yet been effectively controlled, with no sign of an inflection point, leading to continued growth in demand for nucleic acid testing kits abroad. Second, as customs gradually reopen, there remains a substantial need for test kit supplies to support nationwide population screening in China.

Currently, DaAn Gene has secured patent protection for its COVID-19 nucleic acid testing kits in overseas markets. Its next strategic plan is to prioritize expansion into international markets by launching its domestically developed COVID-19 nucleic acid testing kits abroad.