品名：Seraseq® FFPE TMB RM Score 13 

货号：0710-1618 

品牌：SeraCare 

Product Specifications - FFPE TMB Score 13 

TMB Score：12.1 ± 0.3 

Size： 2 x 10 µm 

Format：FFPE 

DNA Yeild：>100 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 Tumour Mutational Burden (TMB), which has 

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

NGS assays 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 (require 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 is then cut into 10 um 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