[Edaily Reporter Kwon Oh Seok ] NGeneBio Co., Ltd.(354200)’s stock price surged to the daily upper limit immediately after the market opened. It appears that buying interest is surging following news that the company has secured European regulatory approval for its hereditary cancer diagnostic panel.

According to MP Doctor on the 11th, as of 9:12 a.m., NGeneBio Co., Ltd.’s stock is trading at 2,595 won, up 29.94% from the previous trading day.
Earlier today, NGeneBio Co., Ltd. issued a press release announcing that its hereditary cancer diagnostic panel, “BRCAaccuTest PLUS,” had obtained quality management system certification in accordance with the European In Vitro Diagnostic Medical Devices Regulation (IVDR).
Building on its existing CE-IVDD certification, NGeneBio Co., Ltd. has been supplying its BRCA diagnostic panel to countries such as Poland, Türkiye, and Lithuania. As Europe’s in vitro diagnostic medical device regulations transitioned to the CE-IVDR framework—which strengthens requirements for clinical evidence, performance evaluation, and quality control—the company underwent the certification process to meet the new standards.
With this certification, the company plans to expand its existing European supply chain and broaden its business scope in Western European markets, including Germany. Its strategy is to expand its portfolio from the current focus on blood cancer diagnostic products to include diagnostic products for hereditary cancers and solid tumors. It also plans to pursue joint research with local pharmaceutical companies and medical institutions on biomarkers for evaluating treatment response.