[Asia Economy Reporter Hyunseok Yoo] GenCurix, a molecular diagnostics company specializing in liquid biopsy, announced on the 3rd that it has obtained export approval from the Ministry of Food and Drug Safety for its non-small cell lung cancer companion diagnostic kit, ‘Droplex cMET Exon14 skipping’.
This product tests for the presence of the cMET gene exon 14 skipping mutation in lung cancer patients using digital PCR (polymerase chain reaction) technology. It is used as a preliminary test to select the most suitable targeted anticancer drug for each individual patient. Currently, the only commercialized products use the expensive NGS (next-generation sequencing) method, and GenCurix’s product is the world’s first using the PCR method.
A GenCurix official stated, “Following the companion diagnostic kits for lung cancer, thyroid cancer, and colorectal cancer in the first half of the year, we have now obtained export approval for the cMET companion diagnostic kit, establishing a unique product portfolio in the global digital PCR-based companion diagnostics market, which is emerging as the next-generation platform.” He added, “This is the result of continuous R&D investment over the past several years in the companion diagnostics field.” He emphasized, “We will expand our market share in the companion diagnostics sector and leap forward as a global leader.”
According to a report by the global research firm Technavio (Global Companion Diagnostics Market), the companion diagnostics market is expected to grow at an annual rate of over 26%, reaching $8.3 billion (approximately 10 trillion KRW) by 2024. Among diagnostic technologies, the entry barriers are highest, and only a few companies worldwide have a comprehensive product portfolio.
cMET is a gene that causes non-small cell lung cancer, similar to EGFR (epidermal growth factor receptor). The mutation causes vary, including overexpression of the cMET gene or deletion (skipping) at exon 14. Approximately 250,000 patients with cMET mutations occur annually worldwide.
Fortune Business Insights forecasts that the market size for non-small cell lung cancer treatments, which account for more than 70% of all lung cancers, will grow to $43.7 billion (approximately 52 trillion KRW) by 2026. Among these, the cMET inhibitor market is expected to grow at an annual rate of 24%.
The company stated, “With recent approvals of cMET-targeted anticancer drugs developed by global pharmaceutical companies, the market is expected to grow rapidly,” adding, “The cMET companion diagnostics market, essential for using new drugs, is also expected to experience rapid growth.”
Among domestic companies, Abion has succeeded in developing the cMET inhibitor ‘ABN401’ and is currently conducting a Phase 2 clinical trial in the United States. GenCurix has also established a partnership and is collaborating with Abion.
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