Freenome, Inc. (Nasdaq: FRNM) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its investigational SimpleScreen Lung blood-based lung cancer screening test.

The designation covers the proposed use of the test 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, ordered by a healthcare provider, is designed to detect early signals of lung cancer from a standard blood draw.

The FDA Breakthrough Devices Program is intended to accelerate the development and review of medical devices for life-threatening or irreversibly debilitating diseases. The designation provides Freenome with interactive communication with the FDA and prioritized review during the premarket submission process.

According to the Centers for Disease Control and Prevention, only about 18% of U.S. adults for whom lung cancer screening is recommended have been screened. Low-dose computed tomography (LDCT) is currently the only guideline-recommended lung cancer screening method.

SimpleScreen Lung uses methylation and proteomics technologies combined with an AI/ML-powered classifier to detect lung cancer signals. A positive result would require follow-up LDCT imaging. The test builds on the same platform underlying Freenome's SimpleScreen CRC colorectal cancer screening test, which received FDA approval the previous month.

"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," said Aaron Elliott, Ph.D., CEO of Freenome.

Freenome presented initial development data for the test at the 2026 American Association for Cancer Research Annual Meeting and is continuing clinical evaluation through its prospective PROACT LUNG study (NCT06122077).