Blood Test for Lung Cancer Screening Receives FDA Breakthrough Device Designation

Lung cancer remains the leading cause of cancer death in the United States, yet only about 18% of people eligible for screening undergo low-dose computed tomography, the current guideline-recommended method. Barriers including stigma, radiation concerns, and logistical challenges continue to limit participation, leaving a substantial screening gap among high-risk individuals. A new blood-based screening test has now received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation as a potential way to expand access to lung cancer screening.

SimpleScreen Lung, developed by Freenome, received FDA Breakthrough Device Designation on August 12, 2026, for use in adults ages 50–80 with at least a 20 pack-year smoking history who are not currently participating in guideline-recommended lung cancer screening. The provider-ordered test is designed to detect early signals of lung cancer from a standard blood draw. Under the proposed indication, a positive result indicates a signal suggestive of lung cancer and should be followed by low-dose computed tomography (LDCT) imaging. A negative result does not rule out lung cancer, and clinicians should determine appropriate follow-up based on individual risk.

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The test is built on a multiomics platform that combines base-level methylation analysis and proteomics with an artificial intelligence and machine learning classifier to determine whether a lung cancer-associated signal is present. The same platform also underpins the company’s colorectal cancer blood test, which received FDA approval in July 2026. By providing a noninvasive blood-based option, SimpleScreen Lung is intended to help patients and providers overcome barriers that can limit participation in LDCT screening.

Through the FDA Breakthrough Devices Program, the designation enables more frequent interaction with the agency and prioritized review during the premarket process. Freenome presented initial development data for the investigational test at the 2026 American Association for Cancer Research Annual Meeting and is continuing clinical evaluation, including through the prospective PROACT LUNG study (NCT06122077).

“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. 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. We continue to advance the clinical work necessary to submit SimpleScreen Lung for FDA review,” said Aaron Elliott, Ph.D., CEO of Freenome.

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