# FDA Grants Breakthrough Device Designation to Freenome SimpleScreen Lung Blood-Based Cancer Screening Test

> fda · REPORTED · 2026-08-12

On August 12, 2026, the FDA granted Breakthrough Device Designation to Freenome's investigational SimpleScreen Lung test, a blood-based AI-powered multiomic screen targeting adults aged 50 to 80 with at least a 20 pack-year smoking history who are not currently participating in guideline-recommended lung cancer screening. The test uses methylation and proteomics biomarkers and a positive result would prompt follow-up low-dose CT imaging.

About Freenome: Freenome is an early cancer detection company developing blood-based multi-cancer screening tests using a proprietary multiomics discovery platform that analyzes circulating cell-free DNA methylation patterns and additional protein biomarkers.

- Company: Freenome
- Sector: diagnostics
- Primary source: https://www.globenewswire.com/news-release/2026/08/12/3343694/0/en/fda-grants-breakthrough-device-designation-to-freenome-s-blood-based-simplescreen-lung-cancer-screening-test.html

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.