[Special Stock] Clinomics, Early Cancer Diagnosis Through Blood... From US FDA Approval to Mass Production System

[Asia Economy Reporter Hyungsoo Park] Clinnomics is showing strong performance. The expectation of commercialization of technology that can diagnose cancer early through blood without biopsy seems to have influenced the stock price.

At 9:43 AM on the 29th, Clinnomics was trading at 21,000 KRW, up 18.58% from the previous day.

On this day, the Korea Institute of Industrial Technology announced that it succeeded in developing a Lab-On-A-Disc system for cancer diagnosis liquid biopsy by providing optimal mold design and manufacturing support to the domestic SME Clinnomics.

Clinnomics developed a Lab-On-A-Disc analysis device that automatically separates blood by placing it in a liquid biopsy cartridge and using centrifugal force from rotation and valve operation. They have completed registration as a Class 1 in vitro diagnostic medical device with the U.S. Food and Drug Administration (FDA), effectively completing commercialization.

Clinnomics needed hundreds of cartridges monthly for research clinical trials, but faced difficulties producing even 10 units per day due to cutting processing and manual assembly methods. Seeking a solution, they visited the Korea Institute of Industrial Technology, where Dr. Cheoljin Hwang’s team in the Shape Manufacturing Research Division found a solution for performance implementation and mass production of the Lab-On-A-Disc through ultra-precision mold design to secure flatness and prevent leakage of the liquid biopsy cartridge. By changing each part to ultrasonic welding bonding, they achieved mass production of stable quality liquid biopsy cartridges.

The cancer diagnostic blood test ‘Lab-On-A-DISC system’ is an analysis device that automatically separates blood placed in a disc-shaped liquid biopsy cartridge with fine channels using centrifugal force from rotation and valve operation. It is a technology that simultaneously separates plasma containing circulating tumor cells (CTC) and circulating tumor DNA (ctDNA) from blood within 30 minutes.

Seonghoon Lee, Director of Clinnomics Cancer Research Institute, said, "We have laid the foundation to take a step further as a liquid biopsy platform company through mass production of high-quality liquid biopsy cartridges," and added, "We expect to greatly contribute to the diagnostic market through genomic analysis."

Previously, Clinnomics successfully completed the ‘10,000 Genomes Project’ jointly led by Ulsan Metropolitan City and UNIST over five years starting in 2016. This national genome project aimed to collect genome information of Koreans to create a standard variant database and contribute to the commercialization of genome-based diagnosis and treatment. Starting in 2016, the genome project collected and decoded genome information (Korea10K) of a total of 10,044 Koreans, including 4,700 healthy individuals and 5,300 patients, with a budget of approximately 18 billion KRW invested to date.

Omics information such as genome, transcriptome, and epigenome collected through blood, saliva, etc., along with health checkup data, clinical information, and lifestyle information, have been comprehensively established. This data can be utilized in ‘multi-omics analysis’ through integrated analysis to find changes related to specific disease causes. This enables more precise genetic disease analysis.