Blood-based tumor mutation burden (bTMB) biomarker, and measuring method and uses thereof

A biomarker and sequencing technology, applied in the determination/test of microorganisms, biochemical equipment and methods, etc., can solve problems such as the inability to effectively predict the OS benefit of tumor patients receiving immunotherapy
CN110643703AActive Publication Date: 2020-01-03CANCER INST & HOSPITAL CHINESE ACADEMY OF MEDICAL SCI +1
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
CANCER INST & HOSPITAL CHINESE ACADEMY OF MEDICAL SCI
Publication Date
2020-01-03

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Abstract

The invention relates to a blood-based tumor mutation burden (bTMB) biomarker, and an measuring method and uses thereof. The bTMB biomarker is obtained from the following steps that cell-free DNA (cfDNA) is obtained from a blood sample of a subject, the number of somatic mutations on sequencing bases is measured, the number of somatic mutations of low allele abundance is taken as the bTMB biomarker and expressed as LAF-bTMB, wherein the low allele abundance means that the allele frequency is less than, for example, 25%, 24%, 23%, 22%, 21%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%,9%, 8%, 7%, 6%, 5%, 4 %, 3%, 2%, 1%, for example, between 0.3% to 25%, preferably less than, for example, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, for example, between 0.5% to 13%, andparticularly preferably less than 6.5%, 6%, 5.5%, 5%, 4.5%, 4 %, 3.5%, 3%, 2.5%, and the LAF-bTMB is calculated according to the total number of mutations in a sample measuring area.
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Description

technical field

[0001] The present invention relates to the fields of biomarkers and gene detection, more specifically, to a blood tumor mutation burden (bTMB) biomarker measured by circulating tumor DNA, a measurement method and application thereof. Background technique

[0002] Tumor immune checkpoint inhibitors (hereinafter referred to as immunotherapy) are currently the most popular immunotherapy in the field of tumors, which include specific antibodies against programmed death receptor-1 and its ligands (anti-PD-1 / PD-L1) And cytotoxic T lymphocyte-associated antigen 4 antibody (anti-CTLA-4), etc. These drugs inhibit the immune escape of tumor cells and mobilize the patient's own immune system to eliminate tumors. At present, immunotherapy has made breakthroughs in the treatment of various advanced solid tumors, especially it can effectively prolong the overall survival (OS) of patients, and the adverse reactions are controllable. However, in the population without mar...

Claims

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