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Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA)

This clinical performance study/clinical investigation will evaluate the safety and effectiveness of GenDx CDx Tedopi in identifying HLA-A*02 status in metastatic NSCLC subjects who may be eligible for treatment with OSE2101.

Implementing a new controlled human infection model with a novel Respiratory Syncytial Virus (RS virus) in healthy volunteers.

The main objective of the study is to establish a controlled human infection model (CHIM) for RSV for future drug and vaccine testing and to identify the inoculation dose needed to induce RSV infection with this new strain in 50-70% of exposed…