BeyondDX has obtained an export manufacturing license for an in vitro diagnostic medical device (Class 3) for early detection of lung cancer from the Ministry of Food and Drug Safety. The approved product is Forecheck LC, Type 1, under the manufacturing license for in vitro diagnostic medical devices by product category.

This product from BeyondDX incorporates our core technology of "multi-integrated analysis solution," achieving superior performance with a sensitivity of 81.9% and specificity of 90.1% in internal exploratory clinical trials compared to standard diagnostics. Additionally, it boasts advantages such as higher price competitiveness and shortened analysis time compared to competing products. Through this export license, we plan to solidify our entry into markets such as China, Europe, and the United States, where there is significant demand for this product. Furthermore, we are preparing for confirmation submissions for domestic approval and launch in the second half of 2024.