[Edaily Reporter KIM JI-WAN ] #GC Genome Corporation is expanding into domestic and international markets by leveraging its AI-based early cancer screening and non-invasive prenatal testing (NIPT). Analysts note that the company is diversifying its growth drivers by pursuing entry into the U.S. early pancreatic cancer screening market, following an increase in domestic test volumes and the start of revenue generation in Japan.

On the 22nd, IVE Research identified the multi-cancer early screening test “ai-CANCERch” and the non-invasive prenatal test “G-NIPT” as GC Genome Corporation’s core growth drivers.

GC Genome Corporation is a company specializing in clinical genomics analysis and liquid biopsy, established in 2013. It currently offers over 300 types of genomic testing services tailored to different life stages and is expanding its business scope from its existing clinical genomics testing business into early cancer diagnosis and overseas markets.

First, ai-CANCERch has begun to show results overseas as both test volume and the number of clients expand in the domestic market.

GC Genome Corporation began generating revenue from ai-CANCERch in Japan starting in the first quarter of this year. The company currently has approximately 33 clients in Japan, and revenue is showing a quarterly upward trend. In South Korea, the company is expanding its customer base, primarily through health screening programs for large corporations.

The next step is the U.S. market. GC Genome Corporation is pursuing a strategy to prioritize the commercialization of its single-cancer early detection test (SCED) for pancreatic cancer over multi-cancer screening in the U.S. market.

The company plans to apply for Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year and subsequently proceed with the full regulatory approval process. According to the company’s stated goals, it aims to generate approximately $30 million in revenue from its U.S. pancreatic cancer early screening business by 2028 and over $100 million by 2030.

Efforts to secure local business partners are also underway. Following the signing of a Memorandum of Understanding (MOU) with Guardant Health, a global liquid biopsy company, GC Genome Corporation is discussing potential business models for commercialization in the U.S. and distribution partnerships. The progress of the FDA approval process and the finalization of local partnerships are expected to be key points of interest for the company’s U.S. operations.

G-NIPT is also cited as another growth driver for GC Genome Corporation.

G-NIPT is a non-invasive prenatal screening test that analyzes a pregnant woman’s blood to detect potential chromosomal abnormalities in the fetus. Launched in South Korea in 2015, it can screen for more than 140 types of chromosomal disorders. A key feature is its ability to link patients to follow-up tests—such as amniocentesis and prenatal chromosomal microarray (CMA)—if a positive result is detected.

Test volume is also steadily increasing. The number of G-NIPT tests rose from approximately 14,000 in 2023 to 25,200 in 2025, and is projected to expand to about 30,000 this year.

In overseas markets, expansion into Japan is the next growth driver. GC Genome Corporation is working to obtain certification from Japan’s Ministry of Health, Labor and Welfare in the second half of this year. Once certification is complete, the company plans to aggressively expand G-NIPT sales in the Japanese market, where testing prices are higher than in South Korea.

IV Research highlighted the possibility that GC Genome Corporation’s growth trajectory will proceed in stages, beginning with an expansion of domestic testing volume, followed by business growth in Japan, and finally entry into the U.S. market.

Key future events identified include: △ an increase in the number of ai-CANCERch tests in Korea; △ expanded ai-CANCERch sales in Japan; △ FDA approval and commercialization of the early pancreatic cancer screening test in the U.S.; and △ certification and launch of G-NIPT in Japan.

As GC Genome Corporation is broadening its business scope from its existing structure centered on domestic clinical genomics testing to AI-based early cancer screening and overseas operations, the realization of key business events—such as U.S. regulatory approval and expansion into the Japanese market—is analyzed as a key variable that will influence the company’s enterprise value.