Freenome received U.S. FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay. The designation covers the proposed use in adults ages 50 to 80 with at least a 20 pack-year smoking history who are not currently participating in guideline-recommended lung cancer screening. SimpleScreen integrates a machine-learning classifier with DNA methylation and proteomics from a blood draw and uses a positive result to recommend follow-up low-dose computed tomography (LDCT). Freenome said it is continuing the clinical work needed to submit the test for FDA review. The company pointed to prior regulatory progress, noting that its SimpleScreen colorectal cancer screening test received FDA approval last month and is being marketed by Abbott beginning in the fall. The designation adds momentum to blood-based lung screening efforts that aim to improve access and triage for CT imaging, which remains capacity-limited in many healthcare systems.