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BeyondDx Obtains GMP Certificate for In-vitro diagnostic device (Grade3)

2024-05-17 13:02:15

On the 17th, Beyond DX obtained the manufacturing and quality control standards (GMP) certification of in vitro diagnostic medical devices (grade 3) for clinical performance tests of ForeCheck LC for lung cancer screening. The clinical performance test plan will be submitted on the 24th, and once the clinical plan is approved, it plans to start clinical trials in the second half of the year at Seoul National University Bundang Hospital.