FDA Grants Breakthrough Device Designation to Freenome’s Blood-Based SimpleScreen™ Lung Cancer Screening Test
Freenome announced that the FDA granted Breakthrough Device Designation to its SimpleScreen Lung test, accelerating the development and review of this investigational blood-based screening tool for adults at high risk for lung cancer. The designation is aimed at addressing the substantial screening gap, as only 18% of eligible U.S. adults currently undergo recommended screening, by offering a non-invasive alternative to low-dose computed tomography (LDCT).
Key figures
- Drug Name
- SimpleScreen™ Lung
- Screening gap
- 18% of U.S. adults for whom screening is recommended have been screened
- Target population
- adults ages 50 to 80 with at least a 20 pack-year smoking history
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