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BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)

The primary objective of the study is to determine whether AVIM therapy in combination with medical therapy is more effective at reducing ambulatory systolic blood pressure (aSBP) and to determine whether AVIM therapy is safe.

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.