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On July 19th, the 9th NGDx 2023 Next-Generation Advanced Diagnostic Technology Development and Application Forum kicked off at Shanghai Longemont Hotel! Yu Jibin, Founder & CEO of GenDx, was invited to attend the special session "Molecular POCT: In-depth Discussion on CRISPR/Rapid Detection Technologies", where he shared insights and delved into the topic "Progress in ERA Enzymatic Isothermal Amplification Technology and POCT Application Development".

First, Yu Jibin, CEO of GenDx, briefly introduced mainstream isothermal amplification technologies such as LAMP and RPA in the current field, and pointed out that combining with CRISPR technology can achieve single-copy detection sensitivity. Prior to nucleic acid molecular detection using CRISPR-Cas, efficient and rapid sample amplification and enrichment is one of the key factors to improve sensitivity and shorten detection time. GenDx owns the globally independent intellectual property rights of Enzymatic Recombinase Amplification (ERA technology) (PCT Application No.: WO2020199342; Chinese Patent No.: ZL109971834B). By simulating the natural amplification and replication mechanism of genetic material in organisms, this technology modifies and screens specific multi-enzyme systems (including recombinases, exonucleases, and polymerases) derived from bacteria, viruses, and bacteriophages. Through optimized combination of different nucleic acid amplification reaction systems, it can amplify specific segments of trace DNA/RNA by billions of times within only 10-15 minutes under isothermal conditions of 37-45°C. Meanwhile, the adoption of unique primer-probe design further accelerates the reaction rate, and molecular binding assays have demonstrated the affinity of dynamic binding between different protein components and nucleic acids.

Currently, ERA technology has successfully integrated with CRISPR-Cas detection, leveraging its advantages of high sensitivity, rapid amplification, and simple reaction conditions. It has assisted thousands of scientists in developing comprehensive genetic testing solutions, such as COVID-19 detection, visual quantitative identification of meat origin in food, mycoplasma detection, and tumor mutation gene detection combined with CRISPR. Compared with other technologies under the same conditions, ERA technology can detect positive samples earlier, significantly improve the specificity and sensitivity of amplification and detection, and yield higher product amounts even with lower initial positive sample loads. In stability tests, ERA products showed no significant performance degradation after 35 days of accelerated testing at 37°C. With nucleic acid extraction-free protocols and large-tube reaction compatibility for instrument loading, ERA technology enables easy, rapid, and error-resistant experimental operations. GenDx's ERA technology has been successfully applied in fields including aquaculture and agriculture, food safety, oncology applications, and clinical diagnostic screening, achieving remarkable results.