Wednesday, May 14, 2025
5/14/2025
Detection of Rare Oncogenic Gene Fusions in Non-small Cell Lung Cancer Using Cytology Samples - DESCRIPTION (provided by applicant): In the US, lung cancer will add 224,210 new cases and cause 159,260 deaths in 2014. Non- small cell lung cancer (NSCLC) accounts for 80% of lung cancer. The availability of targeted therapies directed to driver oncogenes such as EGFR mutations and gene fusions (e.g., EML4- ALK) in recent years has transformed the management of NSCLC. These advances have also created an unprecedented challenge to conduct multiple molecular testing using limited diagnostic materials. In many settings, 40-50% of NSCLC patients present with advanced disease and are simultaneously diagnosed, staged and their tumors molecularly tested for targeted therapy using fine needle aspiration (FNA)-derived cytology specimen obtained during endobronchial ultrasound (EBUS). Liquid-based cytology slides, especially ThinPrep slides, have proven superior to formalin-fixed paraffin-embedded (FFPE) cell blocks for assessing ALK gene status by DNA fluorescent in situ hybridization (FISH). However, the number of ThinPrep slides that can be prepared from a typical EBUS-FNA specimen is limited (usually 2-3). In order to perform multiple testing, an in situ method with multiplexing capability beyond conventional FISH and immunohistochemistry (IHC) is needed. In this Phase I study, we propose to leverage the high sensitivity and multiplexing capability of a recently developed RNA in situ hybridization technology (RNAscope(R)) to develop a novel companion diagnostic algorithm that can efficiently and accurately detect multiple rare but "actionable" oncogenic gene fusions (ALK, ROS1, RET, NTRK1 and others) in NSCLC patients using FNA-derived ThinPrep slides.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).