A multivariate cell-based liquid biopsy for lung nodule risk stratification: Analytical validation and early clinical evaluation.

ABSTRACT:

Background

The Indicator Cell Assay Platform (iCAP) is a novel tool for blood-based diagnostics that uses living cells as biosensors to integrate and amplify weak, multivalent disease signals present in patient serum. In the platform, standardized cells are exposed to small volumes of patient serum, and the resulting transcriptomic response is analyzed using machine learning tools to develop disease classifiers.

Methods

We developed a lung cancer-specific iCAP (LC-iCAP) as a rule-out test for the management of indeterminate pulmonary nodules detected by low-dose CT screening. This included assay parameterization, analytical reproducibility testing, and selection of a fixed 85-gene feature set for future clinical validation and regulatory development. Clinical performance was

SUBMITTER: Berndt JD 

PROVIDER: S-EPMC12359244 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature