Freenome has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its investigational, blood-based SimpleScreen Lung test for adults.
The proposed use targets individuals aged 50 to 80 years who have a smoking history of at least 20 pack-years and are not currently being screened according to existing guidelines.
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This test can be ordered by a healthcare provider and detects early lung cancer signals from a standard blood sample.
It aims to provide a non-invasive option, potentially addressing barriers that limit the uptake of current screening methods such as low-dose computed tomography (LDCT).
The FDA’s breakthrough devices programme targets technologies that could provide more effective diagnosis or treatment for serious conditions and offers selected companies the chance for prioritised review and increased interaction during the approval process.
Freenome CEO Aaron Elliott said: “The breakthrough device designation from the FDA recognises 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.”
The SimpleScreen Lung test is based on Freenome’s methylation and next-generation sequencing platform.
It combines methylation and proteomics with an artificial intelligence/machine learning (AI/ML)-powered classifier to analyse blood samples.
Positive findings suggest a potential signal for lung cancer, which should be further evaluated with LDCT.
Freenome has reported initial data from the investigational test and is continuing clinical evaluation, including the ongoing PROACT LUNG study.
