ABT · News · 20260814N

Regulatory Approval Milestones

ABBOTT LABORATORIES · 2026-08-14 · Importance 31 · Surprise 42

Freenome received FDA breakthrough device designation for its SimpleScreen Lung blood biopsy for early lung-cancer detection in high-risk individuals. The test uses DNA methylation patterns and artificial-intelligence algorithms, similar to Freenome’s SimpleScreen CRC platform. Abbott Laboratories will sell the SimpleScreen CRC test in the United States, indicating a potential expansion of Abbott’s Diagnostics portfolio into blood-based cancer screening.