Freenome, Inc. announced on October 20, 2026, the launch of SimpleScreen Lung, a laboratory-developed test for lung cancer screening, alongside the availability of its SimpleScreen CRC test. The company introduced a combined offering that allows eligible patients to be screened for both lung and colorectal cancer through a single blood draw using two independently validated tests.
SimpleScreen Lung is intended for adults aged 50 to 80 with a smoking history of at least 20 pack-years who are not currently participating in guideline-recommended screening. The test was clinically validated in a case-control study involving 172 lung cancer cases and 436 controls. In this independent cohort, the test achieved 85% sensitivity at 50% specificity and a 99.8% negative predictive value (NPV). Sensitivity varied by cancer stage, reaching 82% for stage I, 75% for stage II, 91% for stage III, and 94% for stage IV. The intended use population includes former smokers regardless of how long ago they quit, consistent with the 2023 American Cancer Society guideline update.
The SimpleScreen Lung test has not been reviewed or cleared/approved by the U.S. Food and Drug Administration (FDA). In contrast, the SimpleScreen CRC test is FDA-approved for adults 45 and older at average risk and is included in the American Cancer Society colorectal cancer screening guideline. Abbott holds exclusive U.S. commercial rights to SimpleScreen CRC when it is ordered as a standalone test.
Performance data for SimpleScreen CRC was derived from the PREEMPT CRC study, which enrolled more than 48,000 participants. The test demonstrated 81% sensitivity for colorectal cancer, 90% specificity for advanced colorectal neoplasia, and a 99.9% NPV in an analysis adjusted to the 2020 U.S. Census age and sex distribution.
