09:29 AM EDT, 08/12/2026 (MT Newswires) -- Freenome ( FRNM ) has obtained breakthrough device designation for its investigational lung cancer screening test SimpleScreen Lung from the US Food and Drug Administration, the company said Wednesday.

The designation applies to the proposed use of SimpleScreen Lung in adults aged 50 to 80 years who have at least a 20 pack-year smoking history and are currently participating in guideline-recommended lung cancer screening, according to a statement.

Freenome ( FRNM ) said that the clinical evaluation of the test is ongoing.