Roche Unveils Next-Generation Digital PCR System Set to Transform Molecular Diagnostics

Recently, at the annual meeting of the Association for Molecular Pathology held in the United States, Roche reported on a digital PCR instrument currently under development.Roche stated that the company plans to obtain CE/IVD certification for the system to enable its commercial deployment in clinical settings, and seeks a 510(k) premarket notification exemption in the United States to facilitate sales.

In the report, Nick Newton, Chief Scientist and Manager of the qPCR System R&D Department at Roche, introduced this new digital PCR system.The system is currently in the prototype development phase and comprises two instruments: a compact desktop partitioning unit and a larger benchtop analyzer. The complete system also includes analysis software that can run on a local laptop or desktop computer.In terms of composition, this system is extremely similar to Bio-Rad’s QX200.

Newton stated,The system requires manual sample loading, with each PCR plate featuring 8 channels.Capillary action draws the sample along the channel to settle into different reaction units. Placing the PCR plate onto the partitioning instrument, the device adds silicone oil sealant to accelerate sample settling and seals the reaction units, ensuring the execution of individual PCR reactions. The partitioning instrument will be equipped with a touchscreen interface, and partitioning each PCR plate takes approximately 2 minutes.Based on this digital PCR system, Roche plans to offer three types of chips for different applications: a general-purpose chip containing 30,000 reaction units; a high-sensitivity chip containing 20,000 reaction units that maximizes sample loading volume; and a high-resolution chip containing 100,000 reaction units that reduces sample loading volume.In contrast, the Bio-Rad platform’s chip partitions a 20 μL sample into 20,000 reaction units.

In addition, Roche’s digital PCR analyzer will fully integrate sealed nano-plates for thermal cycling and partition imaging, with a capacity to hold twelve 96-well plates.The researchers further noted that the system’s most distinctive feature is its superior suitability for multiplexed detection of multiple targets (target multiplexing).Amplification or deletion of genetic loci is associated with various genetic disorders, and multiplex detection technology will help researchers detect more targets and multiple reference genes.

Regarding the new digital PCR instrument developed by Roche, relevant experts believe that,Compared with existing digital PCR platforms on the market and Bio-Rad’s ddPCR platform, researchers prefer to analyze larger-volume samples, as this can improve detection sensitivity.Another approach is to partition the sample into 100,000 reaction units, a method that is highly attractive for detecting rare mutations and mixed targets requiring clonal amplification.Roche's New PCR Instrument May Represent a Major Step Forward in the Digital PCR Revolution.

It has also been pointed out that another potential advantage of the Roche digital PCR instrument is its compatibility with universal reverse transcriptase and a mixed reaction system, enabling better optimization for the detection of genetic variants.Furthermore, the most critical attribute of a digital PCR instrument is reproducibility, encompassing not only the reproducibility of analytical results but also that of the entire workflow from sample preparation to data analysis. Bio-Rad has successfully developed a robust analytical workflow capable of delivering exceptionally high inter-laboratory reproducibility, which is crucial for diagnostic reliability. However, whether Roche’s PCR instruments can match the superior performance of the QX200 remains to be evaluated.

Industry insiders believe that Roche’s newly developed digital PCR instrument will directly compete with Bio-Rad’s QX200 Droplet Digital PCR system.For many years, the digital PCR field was dominated by two major competitors: Bio-Rad and RainDance Technologies. Since Bio-Rad’s acquisition of RainDance in 2017, Bio-Rad has been widely recognized as the leader in digital PCR. In addition, numerous domestic and international sequencing equipment companies have been making sustained efforts in the research and development of digital PCR. Fluidigm was the first company to invest in the development of chip-based digital PCR systems; however, its chip design limited the capability for highly partitioned digital PCR assays. Thermo Fisher Scientific successfully entered the market with its cost-effective QuantStudio 3D system. Many emerging companies are also seeking a foothold in this sector, such as Stilla Technologies (France), Formulatrix (Boston), and JN MedSys (Singapore).

Meanwhile,Several domestic companies have also achieved notable success in the research and development of digital PCR systems.In 2018 alone, the iScanner24 biochip reader developed by Leading Gene received the medical device product registration certificate from the Zhejiang Provincial Food and Drug Administration; New羿 Bio demonstrated China’s first fully independent intellectual property digital PCR system; Kayou Di released its self-developed digital PCR product; and Zhenzhun Bio also launched the AccuOne™ chip-based digital PCR system with independent intellectual property rights. In 2017, Shunde Yongnuo released the MiniDrop™ droplet digital PCR instrument with independent intellectual property rights.

Driven by its quantitative precision and reliability, digital PCR technology is emerging as a new pivotal force propelling the development of precision medicine. As clinical demands for diagnostic testing continue to rise, digital PCR, as a next-generation detection method, is poised for new development and growth, achieving breakthrough applications in fields such as cancer therapy, liquid biopsy, other frontier life science research, and clinical laboratory medicine.