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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.

Validation of Tremor Assessment Software and Exploratory Sweat Lactate Analysis in Essential Tremor and Parkinson’s Disease

Primary Objectives: The primary objectives of this study are: To validate the performance of the Steady Hands software as a medical device in assessing hand tremor symptom intensity for Parkinson’s Disease (PD) and Essential Tremor (ET) by…