Zencurix "Genobio Completes MFDS Registration for Liquid Biopsy CTC Equipment"

[Asia Economy Reporter Hyunseok Yoo] Molecular diagnostics specialist GenCurix announced on the 24th that its subsidiary GenoBio has registered ‘GenoCTC’ as a Class 1 medical device with the Ministry of Food and Drug Safety.

‘GenoCTC’ is a device that isolates CTCs (circulating tumor cells) with high purity. It holds six domestic patents and three overseas patent applications and is being utilized in various clinical studies at major general hospitals in Korea, including Samsung Seoul Hospital, Seoul National University Hospital, and the National Cancer Center.

GenoBio is a company that develops CTC isolation and analysis equipment. CTCs are cancer cells that detach from primary tumors and circulate in the bloodstream, playing a role in cancer metastasis. Along with cell-free DNA (cfDNA) and exosomes, they are considered one of the three key biomarkers. According to the company, since only about five CTCs exist among approximately one billion blood cells in one milliliter (ml) of blood, the detection technology has a very high entry barrier.

A company representative stated, “Despite the high medical value of CTC equipment, only a very small number of companies have succeeded in commercializing the devices due to technological difficulties,” adding, “GenoBio has proven its technological capabilities through registration with the Ministry of Food and Drug Safety and joint research with major general hospitals.”

He continued, “This year will be the first year in which significant results emerge in the liquid biopsy R&D field, where we have invested so far,” emphasizing, “We will strive to solidify our technological superiority alongside market development and growth.”

Meanwhile, GenCurix became the largest shareholder by acquiring a 30.44% stake in GenoBio at the end of last year. According to LP Information, a bio-research specialist company, the global CTC market, currently centered on research use, is valued at approximately 2 trillion KRW and is rapidly growing at about 15% annually.

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