Freenome said the FDA has issued Breakthrough Device designation for its blood-based SimpleScreen lung cancer screening assay. The designation applies to adults ages 50 to 80 with at least a 20 pack-year smoking history who are not currently in guideline-recommended lung cancer screening. SimpleScreen uses a multiomic strategy that pairs a machine learning classifier with DNA methylation and proteomics signals. Freenome said positive results should be followed by low-dose computed tomography (LDCT), positioning its test as a triage tool to identify who should proceed to imaging. The company added that it continues clinical work to submit SimpleScreen Lung for FDA review. It also noted that its SimpleScreen colorectal cancer test received FDA approval last month and would be marketed by Abbott. For the lung cancer screening market, Breakthrough Device status can accelerate interactions with regulators and may shorten the path to eventual adoption if the assay performs robustly across study populations and maintains acceptable false-positive and false-negative rates.