FDA Grants Breakthrough Device Designation to Blood-Based Lung Cancer Screening

The FDA has granted breakthrough device designation to SimpleScreen™ Lung, an nvestigational blood-based lung cancer screening test.¹ The designation covers the test's proposed use in adults 50 to 80 years old with at least a 20-pack-year smoking history who are not currently participating in guideline-recommended screening with low-dose CT (LDCT).

Lung cancer remains the leading cause of cancer death in the United States, yet screening uptake lags far behind eligibility.² According to the Centers for Disease Control and Prevention, approximately 18% of US adults for whom lung cancer screening is recommended have actually been screened, with LDCT remaining the only guideline-recommended modality. Barriers include strict eligibility criteria, low awareness, stigma around smoking history, concerns about repeated radiation exposure, and cost and logistical hurdles.

"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, PhD, CEO of Freenome, in a news releaese.¹

About SimpleScreen Lung

SimpleScreen Lung would be ordered by a health care provider and is designed to detect early signals of lung cancer from a standard blood draw. The test incorporates multiomics—methylation and proteomic signals—processed through an AI/ML-powered classifier to determine whether a lung cancer signal is present. Under the proposed indication, a positive result would indicate a signal suggestive of lung cancer, prompting follow-up with LDCT imaging; a negative result would not rule out cancer, and appropriate follow-up would remain at the provider's discretion.

SimpleScreen Lung builds on the same base-level methylation and next-generation sequencing platform underlying SimpleScreen CRC, Freenome's colorectal cancer screening test that received FDA approval last month.

The FDA's Breakthrough Devices Program is intended to expedite development and review of devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The designation gives Freenome access to interactive, prioritized communication with the agency during the premarket submission process.

Clinical Development Programs

Freenome reported initial development data for SimpleScreen Lung at the 2026 AACR Annual Meeting. The company is continuing clinical evaluation of the test through its prospective PROACT LUNG study (NCT06122077).

REFERENCES

1. FDA Grants Breakthrough Device Designation to Freenome's Blood-Based SimpleScreen™ Lung Cancer Screening Test. News release. Freenome, Inc. August 12, 2026. Accessed August 13, 2026. https://tinyurl.com/mruadryd

2. Siegel RL, Kratzer TB, Wagle NS, Sung H, Jemal A. Cancer statistics, 2026. CA Cancer J Clin. 2026;76(1):e70043. doi:10.3322/caac.70043.