(RTTNews) - Freenome, Inc. (FRNM), an early cancer detection company developing blood-based screening tests, announced that the U.S. FDA granted Breakthrough Device Designation to its investigational SimpleScreen Lung test for early lung cancer screening.
SimpleScreen Lung is being developed for 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 blood-based test is designed to detect early signals of lung cancer from a standard blood draw, potentially helping address barriers associated with low-dose computed tomography (LDCT) screening.
The FDA Breakthrough Device Designation provides Freenome with opportunities for interactive communication and prioritized review during the premarket submission process.
SimpleScreen Lung combines methylation and proteomics technologies with an AI/ML-powered classifier to identify signals associated with lung cancer.
Under the proposed indication, a positive test result would indicate a potential lung cancer signal requiring follow-up with LDCT imaging, while a negative result would not rule out the presence of cancer.
The company said the test builds on its multiomics platform, which also supports SimpleScreen CRC, its colorectal cancer screening test that received FDA approval in July 2026.
The Breakthrough Device designation represents a key regulatory milestone for Freenome as it advances SimpleScreen Lung toward potential FDA review and aims to expand access to lung cancer screening among high-risk individuals.
FRNM is currently trading at $11.60, down 3.33%.
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