Freenome received FDA breakthrough device designation for its blood-based SimpleScreen lung cancer screening assay. The designation covers the assay’s proposed use in 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 combines a machine-learning classifier using DNA methylation and proteomics signals. Freenome said any positive result would be followed by low-dose computed tomography (LDCT), aligning with the standard-of-care imaging pathway. The company added that it is continuing clinical work required to submit SimpleScreen Lung to the FDA. Freenome’s SimpleScreen colorectal test previously received FDA approval, and SimpleScreen Lung is now moving through a parallel regulatory track.