品名：Seraseq® Blood TMB Mix Score 13

货号：0710-2088

品牌：SeraCare 

Product Specifications - Blood TMB Mix Score 13 

Blood TMB 

Score* 14.1 - 20.0 

Tumor Fractions 0%, 0.5%, 2% 

Fill Volume 20 µ1 

Concentration 10 ng/µl 

Total Mass 3 x 200 ng 

*Adjusted bTMB Score after correcting for contributions of somatic variants in the 0% (WT) blend. 

Details

INTRODUCTION 

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, fragmented and sized to ctDNA fragment sizes, and determined their Blood TMB scores by a targeted NGS 

panel. 

The Blood TMB reference materials are formatted as ctDNA (purified mix) in three different tumor fractions. 

Blood TMB Reference Standards 

Reference standards are made from human lung cancer cell lines and their SNP-matched normal cell lines from 

peripheral blood of the same patients. 

Fragmented and blended at 0%, 0.5% and 2% tumor fractions 

Available as a purified ctDNA mix, and ready as input into WES or targeted NGS library preparation 

Blood TMB scores determined using a targeted NGS panel (TSO500 plasma) 

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