It is reported that the digital PCR system developed by Pilot Gene is mainly composed of three modules: a sample preparation instrument, a PCR amplification instrument, and a biochip reader. The approval and commercial launch of multiple products mark that Pilot Gene's digital PCR products have transitioned from the research and development phase to industrialized mass production, which will help advance the development of the precision medicine industry in China.
In recent years, digital PCR technology has been widely favored in precision medicine and become a key focus of the healthcare industry, thanks to its strengths of ultra-high sensitivity and absolute quantification. Against the backdrop that international giants have successively laid out their strategic layouts and domestic enterprises are scrambling to gain a foothold in this segment, Pilot Gene has obtained medical device registration certificates for its digital PCR products one after another. This is particularly noteworthy among domestic manufacturers, given the scarcity of relevant approvals in China at present. DXY conducted an in-depth exclusive interview with Xia Jiang, founder of Leadgene Biomedical, at the earliest opportunity to gain comprehensive insights into these developments.
DXY: Hello Mr. Xia. First of all, congratulations to Pilot Gene on once again receiving approval from the medical products administration. Could you brief us on the details?
Xia Jiang: Certainly. The device newly granted a medical device registration certificate is a clinical polymerase chain reaction (PCR) instrument designed exclusively for use with dedicated chips. Together with the previously approved biochip reader and sample preparation instrument, it constitutes a core part of the digital PCR system. This marks the second medical device registration certificate we have obtained so far this year.The regulatory approval of these products acknowledges the robustness of our entire R&D, quality assurance and manufacturing systems, and further strengthens user confidence in our products.
DXY: Pilot Gene has achieved rapid progress in product development and regulatory approval. Would you share your experience with us?
Xia Jiang: Let me start with regulatory approval. From June 2018 to the present, we have been awarded four medical device registration certificates in succession. Both the number and speed of approvals rank among the top in China's digital PCR industry. This achievement is first and foremost a result of accumulated efforts leading to a breakthrough.Since its inception, Pilot Gene has focused on the development and application of high-end, domestically developed digital PCR platforms, making it one of the early domestic entrants in this field. Accordingly, we have gained in-depth insights into technologies, products and market trends. In 2016, we successfully launched our first product with full independent intellectual property rights, followed by more than one year of clinical validation, which laid a solid foundation for submitting applications to the medical device regulatory authorities.To date, the company has filed over 50 patents related to digital PCR products, with more than 20 granted, placing us among the leading players in China's domestic digital PCR sector.Second, our team is highly diligent and efficient. Pilot Gene boasts a high-caliber workforce with interdisciplinary expertise spanning biology, medicine, chemistry, optics, software and electronic engineering. The R&D team accounts for over 85% of total employees, and we have built an internationally advanced R&D center as well as a GMP-compliant manufacturing base.In terms of product R&D, Pilot Gene has stuck to the path of independent innovation from the very beginning. We firmly believe that enterprises must take proactive innovation to keep core technologies in their own hands, so as to form genuine core competitiveness and develop world-class digital PCR products.
DXY: A number of digital PCR products and manufacturers have emerged in China. Where does Pilot Gene stand in this landscape?
Xia Jiang: Internationally, prominent players include Bio-Rad and Thermo Fisher Scientific, whose digital PCR systems are droplet-based and chip-based respectively, with distinctive technical merits.Pilot Gene's droplet digital PCR (ddPCR) system adopts a proprietary droplet generation technology different from that of Bio-Rad's products. Based on our patented oil-phase formulation and unique microchannel design, the system rapidly generates uniform, stable, single-layer tiled droplets inside a closed chip. This eliminates any additional pipetting after sample loading, minimizing cross-contamination and sample loss caused by manual operation.In addition, the system features five-color fluorescence channels and high-throughput detection supporting 32 droplet chips, which greatly expand the scope of applications and enhance user experience.Thermo Fisher's chip-based digital PCR system has entered the Chinese market through OEM partnerships with domestic manufacturers. Imported instruments and consumables entail relatively high costs, and core technologies remain in the hands of overseas companies, which imposes constraints on the development of our domestic industry.Encouragingly, beyond Pilot Gene, many domestic enterprises have invested heavily in R&D in recent years and successively launched products with independent intellectual property rights. We hope to see a flourishing of innovation in this field, and jointly advance the development of domestic digital PCR technologies through collective efforts.
DXY: Could you share your views on the market outlook of the digital PCR industry and the development strategy of Pilot Gene?
Xia Jiang: Digital PCR technology is characterized by ultra-high sensitivity, absolute quantification, independence from standard curves, and high stability, making it particularly suitable for the detection of ultra-low-abundance nucleic acid molecules. It boasts promising application prospects in tumor liquid biopsy, non-invasive prenatal testing (NIPT), and high-sensitivity detection of pathogenic microorganisms.In February this year, the U.S. FDA approved a digital PCR kit for the detection of the BCR-ABL fusion gene in leukemia, marking the formal entry of this technology into the broad clinical application market.China's molecular diagnostics market is undergoing rapid expansion and is projected to exceed 10 billion RMB by 2021. Digital PCR will serve as a major engine driving the high growth of this market.Since its founding, Pilot Gene has targeted the digital PCR segment, upholding the philosophy of independent R&D and technological innovation. Through continuous upgrading and optimization of core technologies, our products outperform comparable overseas alternatives in several technical details.On the industrialization front, we have intensified our efforts in registration and approval. To our knowledge, a total of six Class II medical device registration certificates for digital PCR products have been issued in China, of which Pilot Gene has secured three, all covering proprietary technologies.Furthermore, multiple products are under development and regulatory review. Our key development directions include:
Further expansion of fluorescence channels to boost multiplex detection efficiency, enabling clinical users to derive more information from a single sample;
Development of an integrated digital PCR workstation for automation and integration, which can complete the entire workflow from nucleic acid extraction to data analysis with only a few simple steps, greatly simplifying manual operation;
Enhancement of detection accuracy through multi-point data acquisition and innovative algorithms.In terms of applications, we have developed a series of testing assays tailored to clinical demands. Several groundbreaking flagship products have entered the clinical evaluation phase for Class III in vitro diagnostic (IVD) reagents.Through sustained efforts, Pilot Gene will deliver a superior user experience with automated, high-throughput, total solutions in the future.Precision medicine represents an irresistible trend, and the digital PCR industry is in the ascendant. This is an excellent era for entrepreneurial enterprises dedicated to this sector.Pilot Gene has made a promising start. We look forward to working alongside domestic peers to accelerate the advancement of the entire industry.
DXY: Thank you very much for this detailed introduction. We wish Pilot Gene even greater achievements in the future!
