Development of 'Early Cancer Detection Equipment' through Collaboration between National Research Institutes and Private Companies

Saenggiwon, Clinomics Collaborate to Successfully Develop 'Lab-on-a-Disc for Cancer Diagnostic Liquid Biopsy'

[Asia Economy Reporter Kim Bong-su] A national research institute and a private company have collaborated to develop equipment capable of early diagnosis of initial-stage cancer, successfully commercializing it and attracting attention.

The Korea Institute of Industrial Technology (KITECH) announced on the 29th that it has succeeded in developing a Lab-On-A-Disc system for cancer diagnosis through optimal mold design and manufacturing support in collaboration with Clinomics Co., Ltd.

Clinomics developed a Lab-On-A-Disc analysis device that automatically separates blood by placing it into a liquid biopsy cartridge and using centrifugal force generated by rotation and valve operation. The core technology is the simultaneous separation within 30 minutes of plasma containing circulating tumor cells (CTC) and circulating tumor DNA* (ctDNA) through microchannels inside the liquid biopsy cartridge.

The problem was that Clinomics needed hundreds of cartridges monthly for clinical research, but it was difficult to produce even 10 per day using cutting processing and manual assembly methods, causing difficulties.

They requested assistance from KITECH, and the team led by Senior Researcher Hwang Cheol-jin from the Shape Manufacturing Research Division stepped in. The research team found a solution for implementing the performance of the Lab-On-A-Disc and mass production through ultra-precision mold design to ensure flatness and prevent leakage of the liquid biopsy cartridge. To realize the microchannels inside the liquid biopsy cartridge, they considered mold and resin temperatures, injection time, and holding pressure comprehensively, applying CAE (Computer Aided Engineering) analysis technology. Through this, they identified optimal injection molding conditions and ultra-precision mold design that highly secured flatness while perfectly blocking leakage. Furthermore, by switching each component to ultrasonic welding bonding, they achieved mass production of liquid biopsy cartridges with stable quality. Additionally, the Korea Mold Technology Center located in Bucheon provided one-stop support from mold manufacturing to parts production for the liquid biopsy cartridges.

As a result, Clinomics completed ISO13485 certification for the manufacturing process and was able to register with the U.S. Food and Drug Administration (FDA).

Senior Researcher Hwang Cheol-jin of KITECH said, "We started collaborating when Clinomics had nine employees, and now the number of employees with master's and doctoral degrees has increased to 85," adding, "It is a great joy as a researcher to support the company's growth process together."

Meanwhile, this research is part of the ‘Leading Research Institute Collaborative Technology Development Project for Supporting Small and Medium Enterprises’ conducted by KITECH. This project supports customized technology development for SMEs by utilizing excellent research infrastructure (personnel, equipment, etc.) possessed by government-funded research institutes including KITECH.