品名：Seraseq® gDNA TMB Mix Score 13

货号：0710-1586 

品牌：SeraCare 

Product Specifications - gDNA TMB Score 13 

TMB Score：12.6 ± 0.02 

Fill Volume：2 x 10 µ1 

Concentration：2x 50 ng/µl 

Total Mass：2x 500 ng

Details

In Immuno-Oncology, the goal is to enable a patient’s immune system to locate and eliminate cancerous cells. 

The immune system may normally protect against cancer – except, when cancers manage to evade it – since 

immunocompromised individuals have a higher likelihood of developing cancer. Checkpoint inhibitors, which 

have recently improved the prognosis for a significant number of cancer patients, work by blocking inhibitory 

molecules such as PD-L1 and CTLA-4 that may be allowing cancers to evade the adaptive immune system. 

However, by taking the brakes off the immune system, the use of checkpoint inhibitors is associated with a 

significant risk of developing autoimmune disease. Additionally, frequently checkpoint inhibitors are not 

effective. 

In order to maximize the safety and efficacy of checkpoint inhibitors, it is beneficial to identify patients who are 

likely to respond to their use. Since the adaptive immune system can detect changes to proteins, it is thought 

that the number of somatic mutations that lead to such changes may be correlated with efficacy. The metric of 

non-silent somatic mutations per megabase of coding DNA has been termed Tumor Mutational Burden (TMB), 

which has shown some correlation to the efficacy of checkpoint inhibitors. Assessments of TMB are being added 

to many NGS assays to enable their use for patient selection in I-O clinical trials, and perhaps as companion 

diagnostics to these therapies. However, it is also known that TMB scores can differ significantly between assays 

and especially around levels that may be clinical decision points. 

To improve and harmonize the measurement of TMB, we have generated and characterized tumor-normal human 

cell lines with different TMB scores by whole exome sequencing, for use in validating targeted NGS panel-based 

TMB assays, and as controls for TMB measurements in I-O clinical trial projects. 

The TMB reference materials are formatted as genomic DNA (purified mix) and/or FFPE (require extraction). 

gDNA TMB Reference Standards: 

Reference standards are made from human lung cancer cell lines and their matched “normal” cell lines from 

peripheral blood of the same patients. 

   100% tumor-normal matched reference standards 

   purified gDNA mix, ready as input into WES or targeted NGS library preparation 

   range of TMB scores 

   manufactured in GMP-compliant and ISO 13485 certified facilities 

维百奥生物代理SeraCare对照及参比物质。

维百奥（北京）生物科技有限公司，自2018年与SeraCare（现隶属于LGC Clinical Diagnostics）合作以来，长期为中国客户

提供包括SeraSeq系列参比物质，领域包括肿瘤、生殖健康和遗传病。SeraCare研发和生产一系列临床参比物质，可以用于任何

研发阶段，以确保临床基因组学检测结果的准确性。

SeraCare参比物质涵盖的范围：

1）Next Generation Sequencing

2）Sanger Sequencing

3）Real-time PCR and digital PCR (dPCR)

4）Microarray

主要特点

1）Ready-to-use reference materials covering clinically-relevant variants and all variant types - SNVs, INDELS, CNVs, 

and RNA fusions

2）Highly multiplexed - provide significantly more data per NGS run, saving sequencing costs

3）Available in multiple formats to suite different workflow needs - purified DNA & RNA, ctDNA, encapsulated ctDNA 

in plasma, and FFPE

4）Manufactured in cGMP-compliant, ISO 13485-certified facilities

5）Stringent product release testing - all variants qualified by dPCR for allele frequencies or copy numbers