GenZon Bio's Digital PCR Products Receive NMPA Approval, Accelerating Clinical Adoption

With its numerous advantages, including high detection sensitivity, more accurate quantitative results, and greater intuitiveness, digital PCR technology is regarded as one of the most critical technological platforms for the future of molecular diagnostics, making it a current hotspot for entrepreneurship and investment. Recently, another domestically produced digital PCR product received approval from the National Medical Products Administration (NMPA), further elevating interest in this field.

On January 18, 2021, ZIZBO announced its independently developedAccuONE Reader for Digital PCR BiochipandDigital PCR Master MixObtain the registration certificate issued by the NMPA.

Left: Biochip Reader

Right: Digital PCR Master Mix

The AccuONE chip reader is compact and flexible to use, featuring three-color fluorescence channels that enable simultaneous detection of three different gene loci. The entire system offers a high degree of automation and ease of operation. Additionally, ZIZBO’s next-generation digital PCR system has recently been launched. Equipped with six-color fluorescence channels, this system supports reading up to 32 chips in a single run, significantly increasing detection throughput while reducing the cost per locus.

Second-Generation Digital PCR Biochip Reader

Currently, digital PCR products on the market are primarily categorized into two technological approaches: droplet-based and chip-based. Droplet-based digital PCR mainly utilizes microfluidic technology to generate water-in-oil droplets, which imposes high requirements on manufacturing processes and makes it difficult to control droplet size. ZIZBO focuses on the development of chip-based digital PCR technology, employing MEMS (Micro-Electro-Mechanical Systems) fabrication processes to achieve physical partitioning of liquid droplets, thereby ensuring droplet stability and uniform size.Extensive experimental data indicate that the performance parameters of AccuONE have met or exceeded those of comparable foreign products.

ZIZBO is dedicated to providing customers with digital PCR products that are both effective and affordable. Currently, imported digital PCR products dominate the domestic market; however, their high instrument and consumable costs deter most customers and significantly hinder the promotion and clinical application of digital PCR technology.The launch of AccuONE will break this impasse. With consumable costs reduced to single-digit figures, it significantly lowers the barrier to entry for customers and paves the way for the widespread clinical adoption of digital PCR.

It is widely acknowledged in the industry that digital PCR (dPCR) represents the developmental trend of PCR technology and is poised to dominate the future landscape of PCR testing. Over the past decade, the dPCR market has experienced robust growth at an annual rate of 20%. In recent years, the dPCR sector has become increasingly vibrant. Internationally, established players such as Bio-Rad and Thermo Fisher Scientific have continued to increase their investments, while newcomers like Qiagen and Roche have actively entered the field. Domestically, companies including ZIZBO, New羿 Biotechnology, and Ruitong Biotechnology have emerged as notable contenders. As these companies accelerate market expansion and promote clinical applications,The Digital PCR Market Is Poised for Explosive Growth.

Digital PCR technology has achieved a qualitative leap in molecular diagnostics from qualitative to quantitative analysis, representing an inevitable trend in industry development.Widely applied in fields such as pathogenic microorganism detection, tumor gene testing, non-invasive prenatal screening (NIPS), and sequencing result validation. Among these, liquid biopsy has garnered significant attention, encompassing multiple aspects including molecular subtyping of tumors, guidance for companion diagnostics, prognostic assessment, and recurrence monitoring. It is estimated that the market size for tumor liquid biopsy in China exceeds RMB 20 billion. Due to its high sensitivity and advantage in absolute quantification, digital PCR (dPCR) is more suitable for tumor liquid biopsy compared to quantitative PCR (qPCR) and next-generation sequencing (NGS).ZIZBO has developed a series of supporting reagents for tumor liquid biopsy and has initiated the registration and certification process.

ZIZBO has officially launched a new round of financing and is sincerely recruiting distributors at all levels across China,We look forward to working with investors and partners to jointly accelerate the rapid development of the digital PCR industry.

ZIZBO, established in 2016 and headquartered at the Juke Biological Park in Xuhui District, Shanghai, is a high-tech enterprise dedicated to the research, development, manufacturing, service, and sales of in vitro diagnostic (IVD) products. Its core team members hail from renowned multinational corporations and research institutions such as Medtronic, Agilent Technologies, Promega, and the Chinese Academy of Sciences, bringing expertise in diverse fields including micro-nano fabrication, precision instrumentation, software and algorithms, and biological reagent development. Currently, ZIZBO has launched digital PCR products with full independent intellectual property rights, enabling absolute quantification of nucleic acid molecules. Upholding its corporate vision of “Making Detection Simpler,” ZIZBO is committed to serving customers in the life sciences and IVD industries with sincerity.