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.

This test can be ordered by a healthcare provider and detects early lung cancer signals from a standard blood sample.