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bTMB marker, detection kit and application bTMB marker

A technology of markers and reagents, applied in the field of medical molecular biology, can solve problems such as the inability to predict the effect of PDL1 immunotherapy

Inactive Publication Date: 2020-07-17
GENESEEQ TECH INC +1
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Problems solved by technology

[0029] The purpose of the present invention is to solve the problem that the calculation standard for bTMB in the prior art cannot better predict the effect of PDL1 immunotherapy

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  • bTMB marker, detection kit and application bTMB marker
  • bTMB marker, detection kit and application bTMB marker

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Embodiment Construction

[0071] The applicant of this patent has previously proved that in NSCLC patients, the correlation between tissue TMB (tTMB) detected and estimated by 425-oncogene Panel (Geneseeq) and the benefit of PD-(L)1 monoclonal antibody treatment (see patent CN109880910A ). In the present study, we performed high-throughput sequencing (NGS) of plasma ctDNA from 97 NSCLC patients and analyzed the association between bTMB and clinical benefit. Using two large randomized clinical trial datasets, we also explored the predictive role of ctDNA MSAF in NSCLC.

[0072]In the present invention, MSAF (maximum somatic allele frequency) is defined as: a somatic mutation with the highest frequency. According to the above detected results, mutation types with different abundances can be found. In each sample, each mutation is sorted according to the abundance, and the mutation with the highest abundance is MSAF. Determining this MSAF value is crucial to the determination process of the present inve...

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Abstract

The invention relates to a blood tumor mutation burden (bTMB) marker, a detection kit and an application the bTMB marker, and belongs to the technical field of medical molecular biology. The inventionverifies clinical practicability of panel estimated bTMB as a biomarker, and the bTMB can be used for identifying patients responding to immunotherapy. On the other hand, research finds that circulating tumor DNA (ctDNA) MSAF is a new biomarker for predicting the therapeutic effect of immunotherapy. Importantly, low ctDNA release is significantly correlated with progression free survival (PFS) benefits, and comprehensive analysis of MSAF and bTMB can greatly enhance enrichment of potential responders. The research result is based on the liquid biopsy of blood, and the ctDNA has important clinical significance and practicability as a source of molecular markers of cancer immunotherapy.

Description

technical field [0001] The invention relates to a bTMB marker, a detection kit and its use, and belongs to the technical field of medical molecular biology. Background technique [0002] Immune checkpoint inhibitors have revolutionized the treatment landscape for many advanced cancers [1]. However, only unselected patients can benefit long-term from immunotherapy [2,3]. Therefore, considerable efforts have been made to improve the efficacy of immunotherapy, including its combination with other anticancer therapeutic agents [4,5], and the identification of biomarkers predictive of efficacy [6-9]. For advanced non-small cell lung cancer (NSCLC), multiple biomarkers have been found to predict the clinical efficacy of PD-(L)1 mAb therapy [2,6,8,10-16], including high tumor mutational burden (TMB), reflecting the overall neoantigen load [13]. However, most current studies are based on tissue samples, which may not be sufficient for multiple testing in advanced patients. Liq...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886C12Q1/6858C12N15/11C12M1/34
CPCC12Q1/6858C12Q1/6886C12Q2600/106C12Q2600/156C12Q2535/122C12Q2537/165
Inventor 邵阳殷嘉妮包华汪笑男吴雪
Owner GENESEEQ TECH INC
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