Brisbane, California, August 12, 2026
Freenome, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SimpleScreen™ Lung, the company’s investigational blood-based lung cancer screening test. The designation applies to the proposed use of SimpleScreen Lung in adults ages 50 to 80 at high risk for lung cancer who have a smoking history of at least 20 pack-years and are not currently participating in guideline-recommended screening. The AI-powered, multiomic test is being developed to identify early signals of lung cancer from a standard blood sample, potentially helping address barriers that prevent eligible individuals from receiving conventional screening.
FDA Breakthrough Designation Supports SimpleScreen Lung
The FDA’s Breakthrough Devices Program is intended to support the development and prioritized review of certain medical devices that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. For Freenome, the designation provides opportunities for interactive communication with the FDA and prioritized review during the premarket submission process. SimpleScreen Lung remains investigational, and the designation does not represent FDA clearance or approval of the test. Freenome said it continues the clinical work necessary to support a future regulatory submission. Lung cancer remains the leading cause of cancer death in the United States, while participation in recommended screening remains limited. According to the company, only approximately 18% of U.S. adults for whom lung cancer screening is recommended have been screened. Current guideline-recommended screening relies on low-dose computed tomography (LDCT). Freenome identifies several potential barriers to LDCT participation, including eligibility requirements, limited awareness, concerns surrounding smoking stigma and cancer diagnosis, repeated radiation exposure, and logistical and financial challenges.
AI and Multiomics Power Blood-Based Screening
SimpleScreen Lung is designed as a non-invasive blood-based screening test that could potentially help identify high-risk individuals who may benefit from follow-up LDCT imaging. The technology builds on Freenome’s methylation and next-generation sequencing platform and combines methylation and proteomics technologies with an AI/ML-powered classifier to determine whether a lung cancer-associated signal is detected in a blood sample. The proposed approach is intended to complement, rather than replace, existing imaging-based screening. Under the proposed indication, a positive SimpleScreen Lung result would indicate that the test detected a signal that may suggest lung cancer, requiring follow-up evaluation with LDCT imaging. A negative result would mean that the test did not detect a lung cancer-associated signal, but would not guarantee the absence of lung cancer. Freenome emphasizes that healthcare providers would determine appropriate follow-up based on each individual’s circumstances. This distinction is important because the test is being developed as a screening tool rather than a standalone diagnostic confirmation of cancer.
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Clinical Evaluation Advances Lung Cancer Screening
Freenome reported initial development data for SimpleScreen Lung at the 2026 American Association for Cancer Research (AACR) Annual Meeting and is continuing clinical evaluation through its prospective PROACT LUNG study (NCT06122077). The ongoing research is intended to generate additional evidence supporting the performance and potential clinical application of the investigational test. The SimpleScreen Lung program follows Freenome’s broader work in blood-based cancer screening and early cancer detection. The company’s multiomics platform analyzes circulating cell-free DNA methylation patterns alongside additional biomarkers to identify cancer-associated signals. The company is also developing SimpleScreen tests for other cancer indications, expanding its focus on technologies intended to detect cancer at earlier and potentially more treatable stages. The FDA designation represents an important regulatory milestone for Freenome’s AI-enabled liquid biopsy technology and highlights continued development of blood-based approaches to cancer screening. If future clinical studies demonstrate sufficient performance and regulatory requirements are met, SimpleScreen Lung could potentially complement LDCT by helping identify high-risk individuals who are not currently participating in recommended screening. However, the test remains under clinical development, and its ultimate clinical utility will depend on further evidence and regulatory review.
Source: Freenome press release
