FDA Grants Breakthrough Device Designation to Freenome's SimpleScreen Lung Test
The designation could speed FDA review of SimpleScreen Lung for high-risk adults not currently screened for lung cancer.
The FDA has granted Breakthrough Device Designation to SimpleScreen Lung, Freenome’s blood-based lung cancer screening test, the company said Aug. 12.
The designation applies to the proposed use of SimpleScreen Lung in adults ages 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 would be ordered by a healthcare provider and is designed to detect early signals of lung cancer from a standard blood draw.
“The Breakthrough Device Designation from the FDA recognizes the substantial unmet need for lung cancer screening and accelerates our path to bring SimpleScreen Lung to patients,” Freenome CEO Aaron Elliott said in a statement. “By identifying high-risk individuals who would benefit from low-dose computed tomography (LDCT), we believe our test will complement the current standard of care and improve detection rates. We continue to advance the clinical work necessary to submit SimpleScreen Lung for FDA review.”
SimpleScreen Lung builds on the methylation and next-generation sequencing platform underlying SimpleScreen CRC, Freenome’s colorectal cancer screening test that received FDA approval last month.
The lung test incorporates methylation and proteomics data; a positive result would be followed by LDCT imaging, while a negative result would not rule out cancer.
Freenome said it has presented initial development data at the 2026 AACR Annual Meeting and is continuing evaluation through its prospective PROACT LUNG study.