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

IGF::OT::IGF BCR-ABL 1 RT-QPCR 测试可改善 CML 监测

• 批准号: 9161353
• 负责人: JUSTIN BROWN
• 金额: $ 148.95万
• 依托单位: ASURAGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-21 至 2017-09-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9161353
• 关键词: ABL1 gene; Agreement; Clinical; Clinical Research; Contractor; Contracts; Diagnostic; Early identification; Laboratories; Life; Minor; Monitor; Patients; Phase; Relative (related person); Reporting; Research Design; Residual Tumors; Site; Testing; Therapeutic; Treatment Failure; Tyrosine Kinase Inhibitor; Validation; bcr-abl Fusion Proteins; design; improved; instrument; manufacturing process; prognostic value; programs

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.

由于BCR-ABL1相对表达水平的预后价值，每3个月监测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，潜在的挽救生命，治疗策略。该项目的长期目标是获得BCR-ABL1 RT-QPCR检验的监管批准，作为FDA清除的IVD，以提高准确，可靠测试的可用性，以监测CML患者的残留疾病。清除涉及内部测试活动，生产多个批次以及在多个独立临床实验室的精确度和准确性测试。 Asuragen在研究设计，临床终点和统计方法上与FDA达成了一致，这些方法已融入该建议。在I期和II期合同之间的过渡期，承包商支持并进行了临床研究以验证BCR-ABL1 RT-QPCR检验。 在第二阶段，Asuragen将进行基本的研究，以开发和临床验证BCR-ABL1次要断点（E1A2）的测试，以及针对主要和次要断点BCR-ABL-1 RT-QPCR测试的制造过程改进和平台扩展研究的研究。