EnGen Bio shares have surged more than 18% during trading hours. The increase follows news that its genetic cancer diagnostic panel has received certification under the European In Vitro Diagnostic Regulation (IVDR), boosting expectations for expansion in the European market.
As of 2:11 PM on August 11, EnGen Bio's stock was trading at 2,360 won, up 18.18% (363 won) from the previous trading day, according to the Korea Exchange.
The rise in stock price appears to be influenced by the announcement of the European regulatory certification for its genetic cancer diagnostic panel, the 'BRCAaccuTest PLUS.' EnGen Bio confirmed that it has obtained quality management system certification in accordance with the European IVDR.
Previously, EnGen Bio supplied its BRCA diagnostic panel to countries including Poland, Turkey, and Lithuania based on the existing CE-IVDD certification. Following the transition to the CE-IVDR system, which strengthens clinical evidence, performance evaluation, and quality management, the company has proceeded with the certification process to meet the new standards.
With this certification, EnGen Bio plans to expand its existing supply chain in Europe and accelerate its entry into Western European markets, including Germany. The company aims to broaden its portfolio from blood cancer diagnostic products to include hereditary and solid tumor diagnostic products.
EnGen Bio is also pursuing collaborations to expand its local operations. The company plans to conduct joint research on biomarkers to evaluate treatment responsiveness with local pharmaceutical companies and medical institutions, thereby strengthening its business foundation in the European market.
* This article has been translated by AI.
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