Freenome received FDA breakthrough device designation for its SimpleScreen lung cancer screening assay, positioning the blood-based, multiomic test for further clinical development. The designation covers a proposed use in adults ages 50 to 80 with at least a 20 pack-year smoking history who are not already participating in guideline-recommended lung cancer screening. The assay combines a machine learning classifier with DNA methylation and proteomics signals, and Freenome said a positive result should be followed by low-dose computed tomography (LDCT). The company is also pursuing FDA review; it previously received FDA approval for a SimpleScreen colorectal cancer screening test. The breakthrough designation can accelerate development interactions with regulators and strengthen the company’s positioning as lung cancer screening extends beyond CT-only pathways. The clinical pathway will hinge on how the test performs in prospective evidence designed for screening settings.