IGF::OT::IGF BCR-ABL 1 RT-QPCR TEST FOR IMPROVED MONITORING OF CML

由于BCR-ABL1相对表达水平的预后价值，接受酪氨酸激酶抑制剂治疗的CML患者每3个月监测一次。治疗失败的早期识别允许修订，可能挽救生命的治疗策略。该项目的长期目标是获得BCR-ABL1 RT-qPCR检测作为fda批准的IVD的监管批准，以提高准确、可靠的检测方法的可用性，以监测CML患者的残留疾病。许可涉及内部测试活动，多批次生产以及多个独立临床实验室的精度和准确性测试。Asuragen已与FDA就研究设计、临床终点和统计方法达成一致，这些都纳入了该提案。在I期和II期合同之间，承包商支持并执行了一项临床研究，以验证BCR-ABL1 RT-qPCR测试。在II期，Asuragen将进行必要的研究，以开发和临床验证BCR-ABL1小断点（e1a2）测试，以及主要和小断点BCR-ABL1 RT-qPCR测试的制造工艺改进和平台扩展研究。

CML patients undergoing tyrosine kinase inhibitor treatment are monitored every 3 months because of the prognostic value of BCR-ABL1 relative expression levels. Early identification of treatment failure allows for a revised, potentially life-saving, therapeutic strategy. The long-term objective of this project is to gain regulatory approval for the BCR-ABL1 RT-qPCR Test as an FDA-cleared IVD to improve the availability of accurate, reliable testing to monitor residual disease in patients with CML. Clearance involves internal testing activities, manufacturing of multiple lots and precision and accuracy testing at multiple independent clinical laboratories. Asuragen has achieved agreement with the FDA on the study design, clinical endpoints and statistical approaches, which are integrated into this proposal. In the interim between the Phase I and Phase II Contracts, the contractor had supported and performed a clinical study for the validation of the BCR-ABL1 RT-qPCR Test. In Phase II, Asuragen will perform essential studies to develop and clinically validate a test for BCR-ABL1 minor breakpoint (e1a2) as well as studies for manufacturing process improvements and platform expansion studies for both the Major and minor breakpoint BCR-ABL1 RT-qPCR Tests.