Freenome received US FDA breakthrough device designation for its blood-based SimpleScreen lung cancer screening assay, targeting adults ages 50 to 80 with at least a 20 pack-year history who are not already in guideline-recommended lung screening. The multiomic test combines a machine-learning classifier with DNA methylation and proteomics and is intended to complement low-dose computed tomography (LDCT). The company said SimpleScreen lung cancer positives should be followed by LDCT imaging, while Freenome continues clinical work to support an FDA submission. The designation builds on last month’s FDA approval of SimpleScreen colorectal, which will be marketed by Abbott. For biotech stakeholders, the decision underscores regulators’ continued openness to blood-based, risk-stratifying screening tools that aim to improve earlier detection while routing eligible patients to imaging confirmation.