Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its investigational SimpleScreen™ Lung blood-based screening test.
The designation covers adults aged 50 to 80 with a smoking history of at least 20 pack-years who are not currently participating in recommended lung cancer screening.
The test is designed to identify early signals of lung cancer through a standard blood draw, offering a non-invasive approach that could complement existing screening methods.
Lung cancer is the leading cause of cancer-related deaths in the US, while screening uptake remains limited.
The Centers for Disease Control and Prevention estimates that only about 18% of adults eligible for lung cancer screening have been screened.
Low-dose computed tomography (LDCT) remains the only guideline-recommended screening method.
SimpleScreen Lung combines methylation and proteomics technologies with an artificial intelligence and machine learning-powered classifier to identify potential lung cancer signals.
A positive result would require follow-up with LDCT imaging, while a negative result would not rule out cancer.
The programme provides Freenome with opportunities for closer interaction with the FDA and prioritised review during the pre-market process.
The company is continuing clinical development of SimpleScreen Lung ahead of a potential FDA submission.
