品名：Seraseq® FFPE TMB RM Score 9 

货号：0710-1308 

品牌：SeraCare 

Product Specifications - FFPE TMB Score 9 

TMB Score：7.5 

Size：10 µm 

Format：FFPE 

DNA Yield*：>100 ng 

*From 1x10 µm FFPE curl using QIAGEN QIAamp FFPE DNA Tissue Kit/Qubit DNA HS quant

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 in order to enable their use for patient selection for clinical trials and perhaps later as 

companion diagnostics. 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 for whole exome sequencing analysis of TMB in patient samples, for validating 

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

The TMB reference materials are available as genomic DNA (purified mix) format and/or FFPE (requires extraction) 

format, as tumor-normal standards. 

FFPE TMB Reference Standards: 

Reference standards are made from human lung cancer cell lines at 30% tumor content, formalin-treated and 

paraffin-embedded into FFPE blocks, which are then cut into 10 µm sections. 

        30% tumor-normal FFPE reference standards 

        compatible with a range of FFPE extraction kits 

        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