Finding the pathogen is a prerequisite for developing diagnostic reagents for clinical and basic testing, and in vitro diagnostics can speed up the determination of the relationship between new pathogens and disease. During the outbreak of infectious diseases, doctors can use in vitro diagnostic equipment to perform various tests on patients’ sides quickly and quickly in outbreak diagnosis, infectious disease areas, and isolated disease areas, and get results quickly.
The new coronavirus (nCoV) is a new virus that has never been found in humans before, and Wuhan’s new virus was named 2019-nCoV. In World Health Organization’s “WHO 2019 Guidelines for New Coronaviruses”, RT-PCR is recommended for the detection of new coronaviruses (WHO standard designation: 2019- nCoV). Serumology is recommended only when RT-PCR is not available. diagnosis.
RT-PCR nucleic acid-positive methods are currently the main method for the diagnosis of new coronaviruses and can play a very important role in the frontline of epidemic prevention and control. However, this method has relatively high requirements on laboratories, supporting equipment and laboratory personnel, and laboratories capable of nucleic acid detection need corresponding levels of biosafety protection. However, the number of laboratories with higher standard experimental conditions is very limited. Therefore, letting RT-PCR detection methods be carried out in any laboratory has become a new idea for some enterprises to think about. This is exactly the direction that Igenesisbio has been cultivating.
Igenesisbio was established in 2015 in Shanghai International Medical Park, and has a R & D center in Guangzhou International Biological Island, with a R & D and production area of 3,000 square meters. It is a high-tech enterprise focusing on molecular diagnostic technology.
Igenesisbio has successfully developed a series of fully-automated biological detectors, reagents and reagent smart boxes suitable for the fields of microbial detection, personalized drug gene detection, cancer detection, forensic material evidence, food safety and other fields. On May 16, 2018, Igenesisbio officially signed a major project of the National “Thirteenth Five-Year Plan”. Its Galaxy Nano fully automatic qPCR all-in-one machine and IGS TB / RIF Lite reagent products will participate in the evaluation.
Focus on real-time molecular diagnostics and independently develop all-in-one PCR machine
The fully automatic qPCR all-in-one machine independently developed by Igenesisbio is the leading instant molecular diagnostic system in China. For the nucleic acid detection of the current new coronavirus (2019-nCoV), traditional PCR requires three rooms, while Auran’s solution requires only a fully automatic qPCR all-in-one machine with a smart box pre-installed with the new coronavirus nucleic acid detection reagent. That’s it.
Doctors can put the full-automatic qPCR all-in-one machine and smart box into the biosafety cabinet as a whole, and perform sample opening, sample addition, and testing processes in the same biosafety cabinet. The complete system contains instruments and consumables, and is lightweight. It can be used in outpatient clinics as well as on-board testing.
Fully enclosed fully automated fluorescent PCR all-in-one machine (picture from the enterprise)
This system is particularly suitable for the detection of samples of potentially infectious pathogens. The system uses a fully sealed smart box with pre-installed reagents. Virus lysis, nucleic acid purification, qPCR amplification and detection are all performed in the smart box.
Compared with the nucleic acid extraction workstation, Igenesisbio’s fully automatic qPCR all-in-one machine can prevent pathogens from contaminating the laboratory environment, and at the same time, it increases the barrier for operator safety. Virus lysing and nucleic acid extraction and purification are completely enclosed to ensure that the nucleic acid does not pollute the laboratory environment and avoid the possibility of false positive detection. The liquid transfer and qPCR amplification detection process are fully enclosed to prevent false positives due to aerosol leakage of amplification products.
The amplification primer probes of the new coronavirus detection kit used in the instrument adopt the sequence recommended by WHO, which can detect 3 conservative segments at the same time to avoid possible mutations and miss detection. Enzyme and Buffer system adopts mature RNA virus detection system, and nucleic acid extraction is refined by magnetic bead method to improve detection accuracy. The system quality control adopts the entire internal standard of RNA pseudovirus to comprehensively monitor the nucleic acid extraction and qPCR amplification detection process to avoid false negatives.
In addition, in the 90-minute test period, the doctor only needs to perform a 2-minute sample addition operation and wait for the results. The operation process is simple, suitable for any experimenter, minimizing the workload and avoiding misoperation due to fatigue under overtime working conditions.
Igenesisbio’s fully automatic qPCR all-in-one machine and smart box platform is a multifunctional platform. Its unique seven-color optical system can detect up to 6 different targets of fluorescent probes (excluding internal standards), which can be used for the next research and prevention work. Provide more possibilities.
In addition to the new coronavirus, Igenesisbio has developed a variety of application reagents for disease control systems to meet the rapid and multiplexed detection of various respiratory, intestinal and arboreal diseases. It is worth mentioning that the Galaxy Nano and Orion independently developed by Igenesisbio have obtained EU CE certification, and Universal Nano has obtained three types of medical device registration certificates.
Deeply plowing the industry for more than ten years, the team is highly complementary
Igenesisbio’s products can achieve this level, which is closely related to the core team’s capabilities and experience.
As the chairman of the board, Yu Jiachang was born in the aerospace field, and then crossed the field to the Internet communication field. He once worked for 3COM, the “father of Ethernet”. In 2001, an incident of Bacillus anthracis occurred in the United States. At the same time, Cepheid, a global leader in molecular diagnostics, used real-time fluorescence detectors to detect microorganisms using qPCR technology to quickly detect the bacteria.
This incident gave Yu Jiachang a great deal of excitement and also an opportunity for him to enter the field of biotechnology. After 2 weeks, Yu Jiachang joined Cepheid Company, participated in the development of the world’s first fully automated nucleic acid extraction, amplification, and detection instrument GeneXpert system using microfluidic technology, and was later in danger when Cepheid’s products suffered serious quality problems. Chief in charge.
“The past work experience has benefited me so far.” Yu Jiachang bluntly stated that the system automation work he was in charge of before the change was different from the biomedical equipment system. In fact, Igenesisbio is the second biotechnology company founded by Yu Jiachang. Igenesisbio’s core technical team is an “old friend” who has followed Yu Jiachang for many years. The specialty covers six major fields, including light, electricity, machinery, software, and biology, and the specialty is highly complementary.
At present, the products developed by Igenesisbio have applied for 64 patents, and more than 41 have been authorized. Among them, 8 invention patents have been authorized, and 7 software copyrights have been obtained. In Yu Jiachang’s view, intellectual property is also a reflection of the company’s own value. Igenesisbio is in a high-speed growth stage, with R & D investment accounting for more than 70%, and it will continue to increase technology R & D investment in the future.
Professional teams and high-quality products are favored by investment institutions. In November 2016, Igenesisbio received more than 50 million yuan in Series A financing from Shenzhen Bangqin Biological; just one year later, Igenesisbio introduced a strategic investment of 30 million yuan from Kehua Bio, a listed company in the IVD industry, to support technology research and development.
2020 will be the closing year of Igenesisbio’s “13th Five-Year Plan” major project. With the acquisition of Igenesisbio’s first Class III medical device registration certificate, its Universal Nano nucleic acid amplification analysis independently developed by it will be officially put into use in hospitals. In this year, Igenesisbio will successively launch new technologies and products such as multiple influenza detection kits to accelerate the development of second- and third-generation test library automation platforms.