[E-Daily Reporter NA EUN-KYUNG ] Genomictree Inc.(228760)is known in the market as the developer of “EarlyTec-C,” an early-stage colorectal cancer diagnostic test, and “EarlyTec-B,” an early-stage bladder cancer diagnostic test. However, Genomictree Inc. defines itself not merely as a diagnostic company but as a “biomarker platform” company.

The company’s capabilities in deoxyribonucleic acid (DNA) methylation research and biomarker discovery—accumulated since its early days—have expanded beyond the development of colorectal and bladder cancer diagnostic products to include a messenger ribonucleic acid (mRNA)-based therapeutic platform. Attention is focused on whether the data and research experience accumulated over more than 20 years will lead to new growth drivers in the therapeutic field beyond diagnostics.

Targeting CNS and Immune System Delivery Platforms via TPD

Genomictree Inc. did not start out as a diagnostic company. CEO Ahn Seong-hwan conducted cancer research using DNA microarray technology while studying in the United States and founded Genomictree Inc. in 2000 based on this work.

Genomictree Inc.’s goal was not so much the development of specific products as it was the establishment of a biomarker platform to identify cancer-related genetic changes. The core assets accumulated over the past two decades are not individual products, but rather cancer-related DNA methylation data and a platform for biomarker discovery and analysis.

Genomictree Inc. recently unveiled its mRNA therapeutic platform, “LipoRnaX,” which is also an extension of the company’s accumulated technological expertise.

Genes are similar to light switches: necessary genes are turned on, and unnecessary genes are turned off. A key mechanism regulating these switches is DNA methylation. When a methyl group (-CH₃) is attached to DNA, the activity of that gene is suppressed. While this is a natural regulatory process in normal cells, abnormal methylation repeatedly occurs in specific genes within cancer cells. For example, when tumor suppressor genes are inactivated by methylation and their expression is suppressed, the growth and proliferation of cancer cells can be promoted. Genomictree Inc. utilizes these methylation changes as signatures of cancer to diagnose colorectal and bladder cancers.

Based on methylation research data accumulated over many years, Genomictree Inc. is investigating therapeutic strategies to restore these gene functions. According to Genomictree Inc., research on restoring the bladder cancer tumor suppressor gene PENK has confirmed the suppression of cancer cell growth and a reduction in invasiveness.

While its existing diagnostic business has focused on early cancer detection, its therapeutic research is expanding toward regulating the very causes of cancer.

Genomictree Inc. is developing an mRNA-based targeted protein degradation (TPD) platform that goes beyond diagnosis. The company is researching next-generation anticancer drugs that degrade mutated proteins in the RAS family, including KRAS. Although KRAS has long been considered an “impenetrable” target, RAS family proteins—including KRAS—are emerging as key targets in the global anticancer drug market following the successive launches of KRAS G12C mutation-targeted therapies such as Amgen’s Lumakras (active ingredient: sotorasib) and BMS’s Krazaati (active ingredient: adagrasib).

Genomictree Inc. has currently confirmed, at the proof-of-concept (PoC) stage, the potential for pan-RAS protein degradation and cancer cell death. In addition, the company is developing delivery platform technologies that target the central nervous system (CNS) and immune cells. As the research is still in its early stages, it is expected to take a considerable amount of time before commercialization. Nevertheless, it is noteworthy that a company known primarily as a diagnostics firm is expanding its research scope into therapeutics to establish a new growth engine.

Diagnostics Business Set to Bear Fruit… Expectations for First Year of Earnings Growth

The securities industry anticipates that Genomictree Inc.’s cancer in vitro molecular diagnostic products—including EarlyTec-C and EarlyTec-B, which form the core of its business—will enter a phase of full-scale growth starting this year. SANGSANGINVESTMENT&SECURITIES noted that while most revenue currently comes from EarlyTec-C, EarlyTec-B’s non-reimbursed prescriptions are set to begin in the second half of this year, and domestic sales are expected to ramp up in earnest starting next year, significantly expanding its contribution to revenue.

They also identified the insurance listing of Earlytec-C, its approval in China, and Earlytec-B’s entry into the U.S. market as key catalysts for a revaluation of the company’s enterprise value. IV Research projected that an increase in test volumes—driven by Earlytec-B’s entry into the domestic non-insurance market and Earlytec-C’s insurance listing—will lead to earnings growth. The Korea IR Council projected that consolidated revenue would increase by approximately 68% from 3.8 billion won last year to about 6.4 billion won this year, analyzing that the launch of Earlytec-B in the domestic market, along with Earlytec-C’s sales in Europe and its approval in China, would drive revenue growth.

The company’s strategy is to establish a stable revenue base in the short term through the evaluation of new medical technologies for the EarlyTec product line and the expansion of the health screening market, and to use this as a foundation to accelerate the development of its therapeutic platform. Based on the cash flow generated from the diagnostics business and the results of methylation biomarker research, the company aims to expand its therapeutic pipeline and, in the long term, transform into a platform company encompassing both diagnostics and therapeutics.

Director Oh stated, “Although we initially focused on developing diagnostic products for colorectal and bladder cancers, the biomarker and methylation research capabilities we accumulated during that process have become assets that can be expanded into various diseases and therapeutic areas.” He added, “Going forward, we plan to demonstrate the potential of our platform one step at a time, moving beyond diagnostics into the therapeutic field.”