Challenging the global lung cancer screening market
Beyond DX has obtained export manufacturing permit from the Ministry of Food and Drug Safety for “Forecheck LC”, an in vitro diagnostic medical device for early detection of lung cancer.
Beyond DX announced on the 25th that it has received export manufacturing permit from the Ministry of Food and Drug Safety for “Forecheck LC”, an in vitro diagnostic medical device (grade 3) for early detection of lung cancer.
According to Beyond DX, this product applied core technology, multiple integrated analysis solution, and achieved excellent performance compared to standard diagnosis with a sensitivity of 81.9% and specificity of 90.1% in clinical research studies internal. Another strong point is the high price competitiveness and the short analysis period.
A Beyond DX official said: “The earlier lung cancer is diagnosed, the higher the survival rate. Currently, developed countries are adopting government-led lung cancer screening policies, so it is expected to form a global market worth $5.6 billion by 2030. “We are realizing our entry strategy into Europe and the United States, starting with China, which has the greatest unmet needs,” he added.
Meanwhile, Beyond DX is preparing confirmatory clinical trials for the product in the second half of 2024 for nationwide approval and launch.
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