[Edaily Reporter YU JIN-HEE ] Digen, a genomics-based precision medicine company, is accelerating its global expansion with “OncoFREE,” a breast cancer prognosis prediction test that utilizes next-generation sequencing (NGS) technology. Taiwan, which has a healthcare environment similar to South Korea’s, is the first target in the East Asian market. The company’s strategy is to expand its reach through collaboration with local partners and, building on this foundation, rapidly achieve annual sales exceeding 10 billion won and complete its KOSDAQ listing.

Collaboration with Taiwan-listed pharmaceutical company TSH Biopharm... Local Prescriptions Begin

According to industry sources on the 23rd, Digen is accelerating its entry into the Taiwanese market starting in the second half of the year, based on a partnership with TSH Biopharm, a Taiwanese publicly traded pharmaceutical company. TSH Biopharm, Digen’s local partner, is a mid-sized pharmaceutical company headquartered in Taipei, Taiwan. It possesses a robust sales network covering local hospitals and medical institutions.

To ensure a successful overseas expansion, Dicigen has built external credibility by obtaining domestic regulatory approvals and accumulating results from numerous clinical studies. It has also strengthened its commercialization foundation by securing College of American Pathologists (CAP) accreditation for its laboratory.

Recognizing that success in Taiwan—its first market in East Asia—will translate into global credibility, the company has made thorough preparations for its local market entry. A prime example of this is the product training, academic, and marketing activities it has been conducting for local medical professionals since 2024. Most recently, the company participated in the “Taiwan International Breast Cancer Symposium 2026” (TIBCS 2026) held in Taipei, Taiwan, where it presented the latest research findings on OncoFree, generating significant interest. TIBCS is a leading international academic event organized by the Taiwan Breast Cancer Society.

Initial reactions have been positive. Taiwanese breast cancer specialists who have actually used the product have highlighted OncoFree’s clinical value. They expressed support for the necessity of prognostic testing in the process of making patient-tailored treatment decisions. This has led to the spread of clinical evaluations among medical professionals, resulting in a steady increase in actual prescriptions. Consequently, the company is seeing a positive cycle where the number of medical professionals and institutions using the product continues to grow.

Dicigen aims to establish the product in the market as early as possible. The basis for this confidence lies in the product’s capabilities. OncoFree is a second-generation precision diagnostic device that overcomes the limitations of existing first-generation tests. First-generation products, primarily from the U.S., examined 21 genes individually using quantitative reverse transcription polymerase chain reaction (qRT-PCR). In contrast, OncoFree performs a comprehensive quantitative analysis of the RNA expression levels of 179 genes within cancer tissue. It analyzes this data using its proprietary algorithm to derive the “Decision Index” (DI). This principle clearly quantifies the risk of metastasis to other organs within 10 years.

Given the vast amount of data it processes, its discriminatory power is exceptional. According to long-term 10-year clinical results, the 10-year metastasis-free survival rate for the OncoFree low-risk group was 96.1%. The high-risk group, by contrast, recorded a rate of only 79.3%. The hazard ratio (HR) was 5.86, indicating that the difference in recurrence risk between the high-risk and low-risk groups was approximately sixfold. This represents world-class discriminatory power. Its reliability was officially recognized when it received approval from the Ministry of Food and Drug Safety as a multi-gene test kit for predicting the prognosis of invasive early-stage breast cancer.

Data tailored to Asian patients is another powerful asset. Existing Western diagnostic kits failed to fully reflect the characteristics of Asians, who have a high proportion of young, premenopausal patients. In a comparative clinical trial of patients aged 50 or younger, OncoFree recorded an area under the curve (AUC) of 0.71. This result far surpassed the 0.62 achieved by global competitors, demonstrating a competitive advantage. AUC is a metric that measures a test’s discriminatory power on a scale from 0 to 1. The closer the value is to 1, the higher the diagnostic accuracy.

Comprehensive Expansion of Global Presence... Seeking Local Approval in the U.S.

Dicigen is expanding its global reach across the board, not just in Taiwan. This is thanks to the company having established a solid foothold for its diagnostic services in about 10 Southeast Asian countries, including Thailand, the Philippines, and Malaysia, which has created the necessary capacity for further growth. The company has also signed a contract with India’s largest diagnostic firm, Dr. Lal Path Labs, and is now prepared to target this massive market. It has secured a foothold in Europe through Hungary’s DeltaBio 2000.

The roadmap for entering the U.S. market has also taken shape. The company plans to validate the efficacy of its products in Western populations using cohort data from the Austrian Clinical Trials Collaboration Group (ABCSG). Through this effort, it is aiming directly for inclusion in the National Comprehensive Cancer Network (NCCN) guidelines. Once listed in global standard treatment guidelines, the process of securing local insurance coverage will gain significant momentum.

Solid overseas performance serves as a strong foundation for the company’s successful KOSDAQ listing. Dicigen has long since resolved the earnings gap, which is often cited as a chronic limitation of biotech startups. The company has consistently recorded annual sales in the 4 billion won range. This year, driven by domestic sales following approval from the Ministry of Food and Drug Safety (MFDS) and the full-scale rollout of prescriptions in Taiwan, the company forecasts sales of 8 billion won—double that of the previous year. With the addition of expanded prescriptions in Asian markets such as Taiwan, annual sales exceeding 10 billion won are within reach.

In South Korea, the company has been selected for a moratorium on the evaluation of new medical technologies and is awaiting an official notice from the Ministry of Health and Welfare. Once the notice is issued, the product will be eligible for coverage under domestic out-of-pocket medical insurance, paving the way for a quantum leap in performance. Currently, Dicigen is able to supply OncoFree at approximately half the cost of the U.S.-made test, which runs about 4.2 million won.

The company also has a robust pipeline. Development of “OncoFree-PC,” a prostate cancer prognosis prediction tool, has been completed, and the company has secured over 900 tissue samples. “SurgiFREE,” which determines the need for thyroid cancer surgery, is on track to receive regulatory approval within two years. “OncoDict-CF,” a liquid biopsy-based minimal residual disease (MRD) diagnostic solution, is also under development.

Han Won-sik, CEO of Digen, emphasized, “OncoFree is the epitome of precision medicine, reducing the suffering caused by unnecessary cancer treatments,” adding, “We will leap forward to become the world’s leading genomic analysis company by leveraging our unparalleled clinical evidence and price competitiveness.”