Freenome's SimpleScreen Lung has received FDA Breakthrough Device designation for its investigational blood-based test aimed at adults 50–80 with a ≥20 pack-year smoking history who are not currently screened. The provider-ordered assay uses DNA methylation, proteomics and an AI/ML classifier to detect early lung cancer signals from a standard blood draw. A positive result should prompt follow-up with low-dose CT; the test remains investigational while ongoing studies, including PROACT LUNG, continue to validate its performance.
FDA Grants Breakthrough Designation to Freenome's SimpleScreen Lung — Blood Test Could Expand Early Lung Cancer Screening
The proposed use targets individuals aged 50 to 80 years who have a smoking history of at least 20 pack-years. Credit: NMK-Studio / Shutterstock.com.
Freenome's investigational blood test, SimpleScreen Lung, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration. The test is intended for adults aged 50–80 with a smoking history of at least 20 pack-years who are not currently undergoing lung cancer screening under existing guidelines.
Ordered by a healthcare provider, SimpleScreen Lung analyses a standard blood sample to detect early biological signals that may indicate lung cancer. The assay combines DNA methylation profiling and proteomics with next-generation sequencing and an AI/ML-powered classifier to interpret blood-derived signals. A positive result suggests a potential signal and should be followed by low-dose computed tomography (LDCT) for diagnostic evaluation; the test itself is not diagnostic.
As a non-invasive option, SimpleScreen Lung aims to address barriers that limit uptake of LDCT screening and to help identify high-risk individuals who could benefit from imaging and further evaluation.
What The Breakthrough Designation Means
The FDA's Breakthrough Devices Program is designed to accelerate the development and review of technologies that could provide more effective diagnosis or treatment for serious conditions. Designation can enable prioritized review and increased interaction with the agency, but it does not equate to clearance or approval.
Clinical Status And Next Steps
Freenome has reported initial investigational data and is continuing clinical evaluation, including the ongoing PROACT LUNG study, to support a future submission to the FDA. The company emphasises that SimpleScreen Lung remains investigational while additional studies validate its performance and clinical utility.
Aaron Elliott, Chief Executive Officer, Freenome:
'The breakthrough device designation from the FDA recognises the substantial unmet need for lung cancer screening and accelerates our path to bring SimpleScreen Lung to patients. By identifying high-risk individuals who would benefit from LDCT, we believe our test will complement the current standard of care and improve detection rates.'
Clinicians and patients should regard a positive SimpleScreen Lung result as an indicator to pursue imaging and clinical follow-up rather than as a definitive diagnosis. Freenome's approach is intended to triage patients to LDCT, not replace standard diagnostic pathways.
Help us improve.
