Comparison of the Clinical Sensitivity of the Idylla Platform and the OncoBEAM RAS CRC Assay for KRAS Mutation Detection in Liquid Biopsy Samples
Comparison of the Clinical Sensitivity of the Idylla Platform and the OncoBEAM RAS CRC Assay for KRAS Mutation Detection in Liquid Biopsy Samples
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DOI：
10.1038/s41598-019-45616-y
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发表时间：
2019-06-20
影响因子：
4.6
通讯作者：
Diaz-Rubio, Eduardo
中科院分区：
文献类型：
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作者：
Vivancos, Ana;Aranda, Enrique;Diaz-Rubio, Eduardo
KRAS基因突变在结直肠癌中很常见。在这种情况下，血液样本(液体活检)中循环游离DNA的突变状态检测已被证明是组织检测的一种可行的替代方案。本研究的目的是比较两种液体活检方法在检测转移性结直肠癌患者血浆样本中KRAS突变的敏感性。采用Idylla ctKRAS突变试验(n=116)对经OncoBEAM Ras CRC检测结果为阳性(KRAS-mut+)且突变等位基因比例(MAF)<lt；5%的样本进行配对分析。在71名随访至少1年的患者中，根据MAF值确定无进展生存期(PFS)。Idylla在81/116例MAF<；5%的OncoBEAM KRAS-MUT+样本和48/79例MAF<；1%的样本中检测到KRAS突变。当MAF值较高时，OncoBEAM和Idyl la之间的一致性显著提高。MAF水平在1%到5%之间的患者在6个月和12个月的PFS率往往低于那些水平为1%和5%的患者
KRAS mutations are common in colorectal cancer (CRC). In this setting, mutation status determination in circulating-free DNA from blood samples (liquid biopsy) has been shown to be a viable alternative to tissue testing. The objective of this study was to compare the sensitivity of two liquid biopsy methods for detecting KRAS mutations in plasma samples from metastatic CRC patients. Samples with a positive (KRAS-MUT+) result and a mutant allelic fraction (MAF) < 5% according to the OncoBEAM RAS CRC assay were pairly analyzed by the Idylla ctKRAS Mutation Test (n = 116). In a cohort of 71 patients with at least 1 year of follow-up, the progression-free survival (PFS) was determined according to MAF values. Idylla detected KRAS mutations in 81/116 OncoBEAM KRAS-MUT+ samples with MAF < 5% and in 48/79 samples with MAF < 1%. Concordance between OncoBEAM and Idyl la significantly improved at higher MAF values. PFS rates at 6 and 12 months tended to be lower in patients with MAF levels between 1% and 5% than in those with levels