FDA Grants Breakthrough Device Designation to Freenome’s Blood-Based SimpleScreen™ Lung Cancer Screening Test

BRISBANE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based screening tests, today announced that the U.S. Food and Drug Administration (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.