Freenome won an FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay, aimed at adults ages 50 to 80 with a 20 pack-year smoking history who are not currently in guideline-recommended screening. The multiomic test pairs a machine-learning classifier with DNA methylation and proteomics signals from a blood draw. Freenome said a positive result should be followed by low-dose computed tomography (LDCT) and that it will advance clinical work toward an FDA review submission. The designation comes after the company’s SimpleScreen colorectal test received FDA approval, with Abbott scheduled to market that assay. For developers of liquid-biopsy platforms, the Breakthrough designation can accelerate interaction with regulators and supports trial design aimed at de-risking clinical performance in higher-risk screening populations.