Blood Test to Predict Radiation Toxicity

DxTerity诊断公司将利用其创新的DxDirect技术开发一种快速、经济高效的原型分析方法，用于测量血液中的辐射毒性。该分析将基于血细胞对体外辐射暴露的基因表达反应特征，而不需要在分析之前对RNA进行纯化。RNA靶标将根据正常和对辐射敏感的淋巴母细胞系的基因表达谱以及先前微阵列研究的生物信息学分析来选择。该方法将用于测量100名放射治疗患者的预期血液样本中全血基因对体外照射的反应。表达结果将与辐射毒性的临床症状相关联，最具信息量的辐射毒性基因将被用于设计放射治疗的配套诊断测试。长期目标是在治疗前识别可能存在辐射毒性风险的患者。这项测试将在DxTerity？S符合CLIA标准的临床实验室建立，在将SOP转移到NCI之前进行优化和验证。由此产生的测试将是减少恶性肿瘤放射治疗并发症的第一个实用和成本效益高的测试，并可以在更大的多中心临床试验中试行。

DxTerity Diagnostics will develop a rapid, cost-effective prototype assay for measurement of radiation toxicity in blood using its innovative DxDirect technology. The assay will be based on the gene expression response signature of blood cells to radiation exposure ex vivo, and will not require purification of RNA prior to analysis. RNA targets will be selected based on gene expression profiling of normal and radiosensitive lymphoblast cell lines and bioinformatic analysis of prior microarray studies. The assay will used to measure whole blood gene expression responses to ex vivo irradiation in 100 prospective blood samples from radiotherapy patients. Expression results will be correlated with clinical symptoms of radiation toxicity, and the most informative genes for radiation toxicity will be used to design a companion diagnostic test for radiation therapy. The long-term goal is to identify patients prior to therapy who may be at risk of radiotoxicity. This test will be established in DxTerity¿s CLIA-compliant clinical laboratory, optimized and validated prior to transfer of the SOP to the NCI. The resulting test will be the first practical and cost-effective test to reduce complications from the radiotherapeutic treatment of malignancies and can be piloted in larger multi-center clinical trials.