FDA grants breakthrough device status to Freenome's lung cancer blood test
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FDA Grants Breakthrough Device Designation to Freenome’s Blood-Based SimpleScreen™ Lung Cancer Screening Test
August 12, 2026 9:00 AM EDTInvestigational AI-powered multiomic test is being developed for adults ages 50-80 at high risk who are not currently participating in guideline-recommended lung cancer screening
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 companys 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... More
