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中文摘要
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ChromoLogic将与匹兹堡大学、维克森林大学、肉瘤肿瘤学和希望之城癌症中心以及Charles River-Laval的经验丰富的团队合作,计划和实施这些研究。具体而言,承包商计划验证ChromoLogic的miRNA面板,以预测临床中性粒细胞减少症(肉瘤患者),并获得FDA批准(1期);验证ChromoLogic的miRNA面板在临床预测纤维化(头颈癌患者)并获得FDA批准(1期);并提交预eua,用于预测ARS(中性粒细胞减少症)和DEARE(纤维化)(2期)。
英文摘要
ChromoLogic will team with the experienced groups at the University of Pittsburgh, Wake Forest University, Sarcoma Oncology and City of Hope Cancer Center, and Charles River-Laval to plan and carry out the studies. Specifically, the Contractor plans to validate ChromoLogic’s miRNA panel to predict neutropenia in the clinic (sarcoma patients), and obtain FDA approval (Phase 1); validate ChromoLogic’s miRNA panel to predict fibrosis in the clinic (head and neck cancer patients) and obtain FDA approval (Phase 1); and submit pre-EUA for panels to predict ARS (neutropenia) and DEARE (fibrosis) (Phase 2).
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