National NanoFab Center Succeeds in Localizing Core Components for Next-Generation Digital PCR Cancer Diagnostics

Securing Mass Production Technology for Semiconductor-Based "MicroWell Disc"
Accelerating Commercialization of Early Cancer Detection Technology

The National NanoFab Center has completed the scaling up and technology transfer of the manufacturing process for the "MicroWell disc," a core component of digital PCR equipment, successfully commercializing next-generation cancer diagnostic devices.

This achievement is significant as it has established a domestic mass-production platform utilizing semiconductor imprinting process technology, enabling the development of highly sensitive PCR technology capable of precisely detecting even trace amounts of cancer gene mutations.

Illustration briefly explaining MicroWell discs and manufacturing technology. Provided by the Ministry of Science and ICT

"Digital PCR" is a next-generation precision diagnostic technology that analyzes trace gene mutations with ultra-high sensitivity for early cancer detection. Since 2021, the National NanoFab Center and Revosketch, a precision medical diagnostics company specializing in digital PCR, have been working on technology development and clinical validation.

The Ministry of Science and ICT announced that the National NanoFab Center has transferred its "MicroWell disc and manufacturing method" technology to Revosketch and established a joint mass production system, resulting in a manufacturing base capable of producing 1 million units annually with a 99% production yield.

Forming Tens of Thousands of Wells at Once with Semiconductor Imprinting Process

The MicroWell disc is a key component of digital PCR, featuring tens of thousands of concave wells measuring 100 to 200 micrometers (μm) in size. It isolates genes from samples into individual wells, then checks for amplification to enable precise analysis.

The National NanoFab Center succeeded in mass-producing well structures by applying semiconductor MEMS (Micro-Electro-Mechanical Systems)-based nano-imprinting technology, directly transferring mold patterns onto curved surfaces. In this process, the center implemented, for the first time globally, a centrifugal digital PCR technology that uses centrifugal force to stably aggregate sample solutions inside the wells.

While global industry players have competed to commercialize digital PCR as a diagnostic device for detecting cancer gene mutations, the precision patterning technology required to stably contain trace samples in tiny microwells has remained a technical challenge. The National NanoFab Center's curved surface imprinting-based well formation method is regarded as a technological breakthrough that overcomes this bottleneck.

1,000 Times Higher Sensitivity Than Conventional PCR... Enhanced Analytical Reliability by Solving the Rain Problem

Revosketch's digital PCR device "digiQuark," which incorporates this technology, enables cancer gene analysis and early cancer detection with approximately 1,000 times higher sensitivity than conventional PCR. In particular, it fundamentally resolves the "Rain Problem"-a phenomenon in which signal amplification is ambiguously overlapped, commonly seen in global competing products-allowing even trace gene mutations to be clearly distinguished by signal.

The results of this technology were published in Volume 14 (11522) of the international journal "Nature Scientific Reports" in May 2024. Since September of this year, it has also been used as a core device for early cancer detection research involving multi-ethnic groups at Massachusetts General Hospital, Harvard Medical School, further demonstrating its global technological competitiveness.

Integration of Technology Development, Validation, and Mass Production... A Successful Model for Commercialization Based on Public NanoFab

This commercialization case is based on the National NanoFab Center's "Innovative Enterprise Mass Production Prototype Development Project" in 2021 and the Ministry of Science and ICT's "Domestic Research Equipment Technology Enhancement Project" in 2024, representing a model of technology commercialization that connects technology development, prototype validation, and mass production scaling. The government highlighted the significance of public NanoFab infrastructure enabling the industrialization of core technologies co-developed with companies.

Lee Kangwoo, Director of Fundamental Technology at the Ministry of Science and ICT, stated, "This technology transfer and digital PCR development is a case where research and development achievements with companies have been successfully commercialized using public infrastructure," adding, "We will continue to support domestic companies in achieving technological independence and enhancing global competitiveness."

Park Heungsoo, President of the National NanoFab Center, emphasized, "This is a model achievement where the stages of technology development, validation, and mass production were organically linked to yield results," and added, "We will continue to drive technology commercialization through semiconductor process-based application technology platforms."

Lee Sungwoon, CEO of Revosketch, commented, "Securing mass production technology for core components would not have been possible without our five-year collaboration," and added, "Building on this technology transfer, we will demonstrate the competitiveness of K-Bio in both joint research with Harvard Medical School and the global precision medicine market."

Digital PCR technology, with its ultra-sensitive DNA analysis and precise mutation detection capabilities, has high potential for use in early cancer diagnosis, monitoring the efficacy of targeted therapies, and personalized precision medicine. The localization and mass production capability of the MicroWell disc manufacturing process achieves technological independence for a key component that has been highly dependent on imports, and is expected to strengthen the competitiveness of Korea's medical device industry and expand exports.

This content was produced with the assistance of AI translation services.