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Freenome's SimpleScreen Lung Receives FDA Breakthrough Device Designation

Freenome announced that the FDA has granted Breakthrough Device Designation to SimpleScreen Lung, the company's investigational lung cancer screening test. The designation applies to the proposed use of SimpleScreen Lung in adults ages 50 to 80 who have at least a 20 pack-year smoking history and are not currently participating in guideline-recommended lung cancer screening. The test, which would be ordered by a healthcare provider, is designed to detect early signals of lung cancer in a blood sample from a standard blood draw.