BCR-ABL1 RT-qPCR Test for improved monitoring of CML

Asuragen正在开发一种灵敏、准确且可靠的检测方法（BCR-ABL 1 RT-qPCR Test），用于定量BCR-ABL 1融合转录本，以监测慢性粒细胞白血病（CML）患者的残留疾病。BCR-ABL 1易位标记物的存在和相对量的分子检测对于危险分层和检测对治疗的应答丧失或次优应答是重要的。由于BCR-ABL 1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个月进行一次监测。早期识别治疗失败允许修改，可能挽救生命，治疗策略。BCR-ABL 1 RT-qPCR检测试剂盒提供了灵敏的检测设计，具有上级质控品和创新标准品，并改进了实验室操作，节省了成本。为了提高准确、可靠检测的可用性，我们的目标是获得FDA批准的IVD监管批准。在第一阶段，我们将完成BCR-ABL 1 RT-qPCR检测的开发，纳入可追溯至世卫组织一级标准品的质控材料，并完成内部设计验证测试。

Asuragen is developing a sensitive, accurate, and reliable test (BCR-ABL1 RT-qPCR Test), for quantification of BCR-ABL1 fusion transcripts to monitor residual disease in patients with chronic myeloid leukemia (CML). Molecular testing for the presence and relative amount of the BCR-ABL1 translocation marker is important for risk stratification and for detecting a loss of response or suboptimal response to therapy. 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 BCR-ABL1 RT-qPCR Test offers a sensitive assay design with superior controls and innovative standards and improves laboratory operations for cost saving. To improve the availability of accurate, reliable testing, our goal is to gain regulatory approval as an FDA-cleared IVD. During phase I we will complete the development of the BCR-ABL1 RT-qPCR Test, incorporating control materials traceable to the WHO primary standards and completing internal design verification testing.