[Click eStock] "Genomictree: Collaboration of Imminent MFDS Approval and European Expansion Momentum"

On December 5, Leading Investment & Securities analyzed that approval from the Ministry of Food and Drug Safety (MFDS) for Genomictree is imminent, and that the company has also secured growth momentum through its entry into the European market.

Genomictree is a company that possesses methylation-based biomarker technology for early cancer diagnosis. It has focused its business on colorectal and bladder cancers, which are particularly inconvenient to test using conventional methods. In particular, investor expectations are rising as the domestic MFDS approval for its bladder cancer diagnostic kit, 'EarlyTect B,' is imminent.

Han Jeyoon, a researcher at Leading Investment & Securities, stated, "According to the results of the In Vitro Diagnostic Medical Device Expert Committee, posted on the MFDS website on November 28, the product was deemed 'useful,' indicating that the clinical utility evaluation has been completed. As the approval process is presumed to be underway, we expect final approval within the year."

Currently, bladder cancer diagnosis typically involves invasive endoscopic procedures, which cause significant discomfort and lead many patients to avoid testing. In contrast, Genomictree's 'EarlyTect B' enables urine-based diagnosis, greatly reducing patient burden. In comparative clinical trials with a global competitor, Company A, EarlyTect B demonstrated a sensitivity of 89.2%, outperforming Company A's 51.5%. Han noted, "Even before MFDS approval, contracts are being signed with various hospitals and companies, which suggests strong actual demand following approval."

The company is also accelerating its efforts to enter the European market. The colorectal cancer diagnostic kit 'EarlyTect C' recently marked the start of full-scale overseas expansion by signing a supply agreement with UK biotech firm EDX Medical. EDX Medical has partnerships with major hospitals in the UK, and immediate sales are expected to begin in January 2026.

The company's primary goal is to apply 'EarlyTect C' to the approximately 380,000 patients who test positive annually in FIT (fecal immunochemical test) screenings. This translates to annual sales of about 53 billion won. Given that colonoscopy procedures in the UK are costly and time-consuming for patients, 'EarlyTect C' is expected to achieve rapid market penetration.

He added, "This entry into the UK market could serve as a key reference for narrowing the valuation gap with Exact Sciences, which was recently sold for about 34 trillion won. This European expansion is expected to be an important catalyst for a revaluation of the company's corporate value."