Freenome said the FDA granted Breakthrough Device Designation for its SimpleScreen lung cancer screening blood test, positioning the assay for a defined population that is not already receiving guideline-recommended screening. The test uses a multiomic approach, including DNA methylation and proteomics, and is intended to be followed by low-dose CT. Separately, NeOnc Technologies disclosed Phase 2a intranasal NEO100 results in recurrent IDH1-mutant high-grade glioma, reporting six-month progression-free survival of 48.9% versus a pre-set 20% benchmark and plans to pursue an FDA Type B meeting for a potential registrational pathway. Together, the updates show how screening and early-phase intracranial programs are trying to secure regulatory engagement via demonstrated signal endpoints.