Freenome received FDA breakthrough device designation for its SimpleScreen lung cancer blood test, a multiomic assay combining machine-learning classification with DNA methylation and proteomics. The designation covers proposed use in adults ages 50 to 80 with at least a 20 pack-year smoking history who are not already in guideline-recommended lung cancer screening. A positive result would be followed by low-dose CT imaging. The company previously received FDA approval for a related SimpleScreen colorectal cancer test, and it is now advancing SimpleScreen Lung toward an FDA review submission.