[Edaily Reporter Kim Seung-kwon ] NGeneBio Co., Ltd.(354200), an artificial intelligence (AI) precision medicine company, has secured European regulatory certification for its hereditary cancer diagnostic panel and is set to expand into the global market.

NGeneBio Co., Ltd. announced on the 11th that its hereditary cancer diagnostic panel, “BRCAaccuTest PLUS,” has obtained quality management system certification in accordance with the European In Vitro Diagnostic Medical Devices Regulation (IVDR). This marks the first time a Korean diagnostic product for breast and ovarian cancer has received such certification.

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 in accordance with the new standards.

Building on this certification, the company plans to expand its existing European supply chain and broaden its business scope in Western European markets, including Germany. The 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. The company also plans to pursue joint research with local pharmaceutical companies and medical institutions on biomarkers for evaluating treatment response.

BRCA AccuTest Plus is a diagnostic panel that utilizes next-generation sequencing (NGS) to analyze various mutations in the BRCA1 and BRCA2 genes simultaneously. It assesses the risk of hereditary breast and ovarian cancer (HBOC) based on a patient’s personal and family medical history and provides information necessary for clinical decision-making.

As an enhanced version of the original BRCA AccuTest, which was commercialized in 2017, this product offers a broader range of mutation detection and higher analytical accuracy. By applying its proprietary analysis algorithm, the company has also reduced data processing time by 3.6 times compared to the previous product.

NGeneBio Co., Ltd.’s BRCA diagnostic panel is currently supplied to 11 countries, including those in Europe and Asia. Over the past five years, overseas sales have grown at an average annual rate of 57%. Building on its CE-IVDR certification, the company plans to expand its market not only in Europe but also into South Asia and Southeast Asia.

Song Myung-jun, Chief Business Officer (CBO) of NGeneBio Co., Ltd.’s Diagnostics Division, stated, “With CE-IVDR certification as a springboard, we will aggressively expand our hereditary cancer and solid tumor portfolios in Western European markets such as Germany, while also broadening our sales channels in new markets including South Asia and Southeast Asia.”