Utility of a Novel High-Sensitivity Multiplex Companion Diagnostic Test Using Formalin-Fixed Paraffin-Embedded Cell Block Materials of Non-small Cell Lung Cancer.

ABSTRACT:

Background

Formalin-fixed paraffin-embedded (FFPE) tissue is the standard material for companion diagnostic tests (CDx). Although cytological specimens can be useful, their low tumor content (TC) poses challenges. Recently, a high-sensitivity CDx, the "Lung Cancer Compact Panel (cPANEL)," with a recommended TC of 5%, was introduced into clinical practice. This CDx achieves high detection sensitivity by selecting specific genes for analysis, processing them separately, and performing sequence at sufficient depth. This approach enables the detection of mutations even when they are present in only small amounts within the sample. This study aimed to evaluate the utility of cPANEL using FFPE cell block (CB) with a low TC.

Methods

We analyzed FFPE-CB pleural fluid samples from 26

SUBMITTER: Shinomiya Y 

PROVIDER: S-EPMC12227799 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature