Pilot Gene is an innovative national high-tech enterprise that is providing production and services in the fields of molecular diagnostics, including R&D, manufacturing and sales of droplet digital PCR instruments and relevant reagents. Since the day of established officially in 2014, we have already achieved variety of groundbreaking fruition on dPCR technology with the young, dynamic, and expert staff.
With a series of high-throughput, high-performance, fully automatic digital PCR systems were lunched in the market, which are widely used in clinical diagnosis, life science, public health etc, we have received consistent praise both at home and abroad. Notably, underpinned by the certificates and qualification of ISO13485, CE-IVD, NMPA Ⅲ, Pilot Gene hold the largest market share in the clinical detection and early screening of sepsis in China harnessing the patented multiplex absolute quantification dPCR.
Currently, our products portfolio is one generation products ahead of our competitive peers, and we are also developing the next generation of products that are more advanced and meet market demands. The continuous development and innovation will not only bring us deeper growth, but also support our partnership in maintaining sustainable competitiveness in their own market. Meanwhile, we always aim further ,continue to strengthen independent research and innovation capacity, expand the production layout and strive to become the world's leading provider of molecular diagnostics products and services.
Our History
2014
- Start Up
- Pilot Gene was founded in Hangzhou.
2016
- The first China Semi-Auto digital PCR
- China's first independently developed semi-automatic digital PCR system was launched.
- Independently developed microfluidic chips and applied for a national high-tech invention patent.
2018
- The first dPCR NMPA Cert.
- Obtained China's first digital PCR registration certificate, leading the era of digital PCR exploration.
- Multiple iterations and upgrades of the semi-automatic equipment product, meeting market demands across multiple dimensions.
2019
- ISO13485 & First sepsis test kit
- Obtained TÜV ISO13485 certification, signifying international recognition of the company's quality management system.
- Launched the world's first bloodstream infection reagent product based on an independent digital PCR platform, entering the bloodstream infection diagnostics field.
2020
- The First fully automated dPCR
- Delivered the world's first domestically produced fully automated digital PCR system to the market, leading the digital PCR industry into the "fully automated era."
2021
- Groundbreaking fruition
- Entered over 40 of China's Top 100 hospitals, Won the largest single procurement in the history of digital PCR, and led the "Vanguard Project."
- Broke through fluorescence channel limitations and obtained the first 7-color fluorescence equipment registration certificate.
2022
- CE cert.& Expert Consensus
- Obtained TÜV CE certification, indicating recognition of product quality under European conformity standards.
- Digital PCR bloodstream infection detection methodology was included and published in multiple expert consensus documents, such as the Expert Consensus on Clinical Testing Pathways for Bloodstream Infections.
2023
- New innovation
- The world's first digital PCR pre-processing system-AP10-received NMPA approval.
- Participated in the National Key R&D Program project on early rapid standardized treatment of septic shock, led by West China Hospital.
- Digital PCR pathogen detection methodology was included and published in consensus documents such as the Expert Consensus on Clinical Application of Nucleic Acid Detection Technologies for Pathogen Diagnosis in Adult Respiratory Tract Infections (2023).
2024
- New development
- The multi-center study on sepsis based on the digital PCR platform, led by Huashan Hospital, published its initial results.
2025
- The First NMPA Ⅲ of Sepsis detection
- The world's first Class III bloodstream infection digital PCR diagnostic kit-"Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii Nucleic Acid Detection Kit (Digital PCR Method)"-received NMPA approval.
- Pilot Gene independently developed fully automated digital PCR systems (AD3205, AD3207) received NMPA approval, marking the beginning of a new chapter in fully automated precise diagnosis for bloodstream infections.
- 67% of the top-notch 100 hospitals in China are our loyal users beside other hundreds of clinical and life science partners.
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Our state-of-the-art manufacturing facility is the cornerstone of our commitment to excellence and the engine behind our high-precision diagnostic solutions. Housing a dedicated and certified molecular laboratory, which has been recognized with prestigious provincial honors, our factory operates under the strictest quality control protocols. We have integrated production lines to ensure unparalleled consistency, scalability, and sterility in the manufacturing of our reagent kits. Every step of the process, from raw material inspection to final packaging, is governed by our comprehensive ISO 13485 quality management system, guaranteeing that every product meets the highest international standards. The factory environment is meticulously controlled, with clean rooms and stringent monitoring systems in place to prevent any form of contamination. This robust infrastructure not only supports our massive domestic distribution but also seamlessly scales to meet the rapidly growing demands of our international clientele, ensuring that every unit shipped globally delivers the same uncompromising quality and performance.
