Blood Test to Predict Radiation Toxicity

DxTerity Diagnostics将开发一种快速，具有成本效益的原型检测方法，用于使用其创新的DxDirect技术测量血液中的辐射毒性。该测定将基于血细胞对离体辐射暴露的基因表达响应特征，并且在分析之前不需要纯化RNA。RNA靶标将基于正常和放射敏感性淋巴母细胞系的基因表达谱和先前微阵列研究的生物信息学分析来选择。该检测方法将用于测量100例放射治疗患者的前瞻性血液样本中全血基因表达对离体照射的反应。表达结果将与辐射毒性的临床症状相关，并且辐射毒性的最具信息性的基因将用于设计用于辐射治疗的伴随诊断测试。长期目标是在治疗前识别可能有放射毒性风险的患者。该检测将在DxTerity的CLIA合规临床实验室中建立，并在将SOP转移至NCI之前进行优化和验证。由此产生的测试将是第一个实用和具有成本效益的测试，以减少恶性肿瘤放射治疗的并发症，并可以在更大的多中心临床试验中进行试点。

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.