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Clinical-Grade tTMB Ref Std for Cancer I-O

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TMB measurement has become a critical biomarker in predicting immunotherapy response and guiding personalized cancer treatment. Our TMB Reference Standards address the urgent need for reliable quality control materials in next-generation sequencing (NGS) workflows. Developed using clinically validated mutation profiles, these standards precisely mimic real tumor genomic characteristics while maintaining batch-to-batch consistency across production lots.

  • CBP80001-1/2/3/4/5/6/7/8

  • CBP80001-1/2/3/4/5/6/7/8

Availability:
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Product Overview


Tumor Mutational Burden (TMB) serves as a pivotal biomarker for predicting cancer immunotherapy efficacy, reflecting the number of mutations per megabase in tumor exomes. Our Clinical-Grade tTMB Reference Standard (Cat. No. CBP80001-9) is a calibrated matrix reference material designed to standardize TMB measurement across next-generation sequencing (NGS) platforms, addressing the poor correlation among different assay systems in clinical settings .

  • Material form: Available in gDNA format (1µg per unit) with optional FFPE and ctDNA derivatives

  • TMB gradient range: Covers 2–28 mutations/Mb to mimic diverse cancer types

  • Validation basis: Verified via whole-exome sequencing (WES) and ddPCR for batch consistency


TMB


Product Benefits


Clinical-Grade Reliability

Cell line-derived matrix highly simulates patient samples, ensuring clinical relevance

ISO9001-certified production process guarantees traceability and minimal batch variation

Paired normal/tumor controls enable germline mutation filtering for accurate somatic variant calling


Versatile Adaptability

Compatible with targeted NGS panels and WES platforms commonly used in cancer I-O research

Adjustable tumor content ratios (10%–100%) simulate heterogeneous clinical samples

Stable under standard laboratory storage conditions with 12-month shelf life


Comprehensive Support

Includes complete WES datasets and open-source TMB calculation pipelines

Provides detailed validation reports for regulatory submission (e.g., NMPA/FDA filings)


Usage


Assay Development & Validation

Optimize TMB detection workflows for IVD kit development

Validate analytical performance (sensitivity, specificity, linearity) of sequencing assays

Calibrate bioinformatics pipelines for consistent TMB scoring


Quality Control Applications

Routine quality monitoring of clinical NGS platforms

Inter-laboratory proficiency testing for TMB measurement harmonization

Batch-to-batch verification of diagnostic reagents


Cross-Platform Harmonization

Compare TMB results across different sequencing systems (Illumina, Ion Torrent)

Bridge discrepancies between targeted panels and WES-based TMB assessments


FAQ


What storage conditions are required?

Store at -20°C upon receipt; avoid repeated freeze-thaw cycles. Diluted samples are stable for 72 hours at 4°C.


Is this product suitable for clinical trial use?

Yes. It meets CLSI guidelines for reference materials and supports analytical validation in clinical trials .


Can it be customized for specific cancer types?

Custom gradients and matrix compositions (e.g., tissue-specific FFPE) are available upon request .


Does it include reference TMB values?

Each lot comes with certified TMB values calculated by WES (500X coverage) and cross-validated by ddPCR .


Why Choose Us


Quality Assurance

Manufactured in ISO9001-accredited laboratories in Nanjing and Shanghai

Rigorous multi-step validation involving 8+ independent testing centers


Technical Capability

10+ years of expertise in molecular diagnostic reference standards

In-house WES and digital PCR platforms for real-time quality control


Customer-Centric Services

Dedicated technical support for assay optimization

Fast turnaround for custom orders and regulatory documentation assistance


General information

Cat.No.

ID

Format

Unit Size

TMB Value

 Method

Buffer

Storage Conditions

Expiry

CBP80001-1

tTMB-P1

 Genomic DNA 1ug+1ug

5.37

WES

 Tris-EDTA 2~8℃ 36 months from the date of manufacture

CBP80001-2

tTMB-P2

Genomic DNA

1ug+1ug

9.84

WES

Tris-EDTA

2~8℃

36 months from the date of manufacture

CBP80001-3

tTMB-P3

 Genomic DNA 1ug+1ug

12.41

WES

 Tris-EDTA 2~8℃ 36 months from the date of manufacture

CBP80001-4

tTMB-P4

Genomic DNA

1ug+1ug

21.09

WES

Tris-EDTA

2~8℃

36 months from the date of manufacture

CBP80001-5

tTMB-P5

 Genomic DNA 1ug+1ug

27.15

WES

 Tris-EDTA 2~8℃ 36 months from the date of manufacture

CBP80001-6

tTMB-P6

Genomic DNA

1ug+1ug

8.98

WES

Tris-EDTA

2~8℃

36 months from the date of manufacture

CBP80001-7

tTMB-P7

 Genomic DNA 1ug+1ug

6.83

WES

 Tris-EDTA 2~8℃ 36 months from the date of manufacture

CBP80001-8

tTMB-P8

Genomic DNA

1ug+1ug

27.15

WES

Tris-EDTA

2~8℃

36 months from the date of manufacture


Detection Methods


Clinical-Grade tTMB Ref Std for Cancer I-O


Detailed Data

1. tTMB-P1(5.37) Reference Standard CBP80001-1

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0153

CBP80001-1N

B lymphoblast, Female

500x WES

Same individual

 

DC198N0152

CBP80001-1T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0 capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0152 is 100% Tumor sample.

Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

180

172

168

166

TMB value

5.37

5.13

5.01

4.95 


2. tTMB-P2(9.84) Reference Standard CBP80001-2

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0159

CBP80001-2N

B lymphoblast, male

500x WES

Same individual

 

DC198N0158

CBP80001-2T

Lung adenocarcinoma, male

500x WES

IDT xGenExome Research Panel v1.0 capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0158 is 100% Tumor sample.

Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

330

313

304

297

TMB value

9.84

9.34

9.07

8.86 

 

3. tTMB-P3(12.41) Reference Standard CBP80001-3

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0161

CBP80001-3N

B lymphoblast, Female

500x WES

Same individual

 

DC198N0160

CBP80001-3T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0160 is 100% Tumor sample.

Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

416

398

386

383

TMB value

12.41

11.87

11.52

11.43 


4. tTMB-P4(21.09) Reference Standard CBP80001-4

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0163

CBP80001-4N

B lymphoblast, male

500x WES

Same individual

 

DC198N0162

CBP80001-4T

Lung large cell carcinoma, male

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0162 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

707

698

691

688

TMB value

21.09

20.82

20.61

20.53 


5. tTMB-P5(27.15) Reference Standard CBP80001-5

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0155

CBP80001-5N

B lymphoblast, Female

500x WES

Same individual

 

DC198N0154

CBP80001-5T

stage 4, adenocarcinoma Lung, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0154 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

910

898.00

888

884

TMB value

27.15

26.79

26.49

26.37 


6. tTMB-P6(8.98) Reference Standard CBP80001-6

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0167

CBP80001-6N

B lymphoblast, Female

500x WES

Same individual

 

DC198N0166

CBP80001-6T

Breast Cancer, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0166 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

301

275

259

254

TMB value

8.98

8.20

7.73

7.58 


7. tTMB-P7(6.83) Reference Standard CBP80001-7

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0157

CBP80001-7N

B lymphoblast, Female

500x WES

Same individual

 

DC198N0156

CBP80001-7T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0156 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

229

218

208

201

TMB value

6.83

6.50

6.21

6.00 


8. tTMB-P8(27.15) Reference Standard CBP80001-8

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0165

CBP80001-8N

B lymphoblast, Female

500x WES

 Same individual

DC198N0164

CBP80001-8T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0164 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

910

840

766

685

TMB value

27.15

25.06

22.85

20.44 



Detection Methods

The current detection methods on the market refer to the number of somatic mutations per million bases (Mb) in the coding region of the patient's targeted sequencing, including point mutations and insertions and deletions. The number of somatic mutations in different cancers ranges from 0.01 mutations/Mb to more than 400 mutations/Mb.

The higher the tumor mutation load, the more likely the corresponding tumor-related carcinogenic mutations are, the more prominent the tumor's personality is, and the more different it is from normal cells.


Regarding TMB detection: Traditional detection technology is to analyze the patient's TMB by taking the patient's tumor tissue (tTMB). Currently, blood TMB (bTMB) can be detected, and compared with tissue detection, blood detection is more convenient and faster, and the non-invasive operation method also avoids more pain for patients.



Detailed Data

1. tTMB-P1(5.37) Reference Standard CBP80001-1


Sample ID

Cat.No.

Background

Assay

Comments

DC198N0153

CBP80001-1N

B lymphoblast, Female

500x WES

Same individual



DC198N0152

CBP80001-1T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0 capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0152 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

180

172

168

166

TMB value

5.37

5.13

5.01

4.95


2. tTMB-P2(9.84) Reference Standard CBP80001-2

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0159

CBP80001-2N

B lymphoblast, male

500x WES

Same individual



DC198N0158

CBP80001-2T

Lung adenocarcinoma, male

500x WES

IDT xGenExome Research Panel v1.0 capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0158 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

330

313

304

297

TMB value

9.84

9.34

9.07

8.86


3. tTMB-P3(12.41) Reference Standard CBP80001-3

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0161

CBP80001-3N

B lymphoblast, Female

500x WES

Same individual



DC198N0160

CBP80001-3T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0160 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

416

398

386

383

TMB value

12.41

11.87

11.52

11.43


4. tTMB-P4(21.09) Reference Standard CBP80001-4

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0163

CBP80001-4N

B lymphoblast, male

500x WES

Same individual



DC198N0162

CBP80001-4T

Lung large cell carcinoma, male

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0162 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

707

698

691

688

TMB value

21.09

20.82

20.61

20.53


5. tTMB-P5(27.15) Reference Standard CBP80001-5

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0155

CBP80001-5N

B lymphoblast, Female

500x WES

Same individual



DC198N0154

CBP80001-5T

stage 4, adenocarcinoma Lung, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0154 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

910

898.00

888

884

TMB value

27.15

26.79

26.49

26.37


6. tTMB-P6(8.98) Reference Standard CBP80001-6

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0167

CBP80001-6N

B lymphoblast, Female

500x WES

Same individual



DC198N0166

CBP80001-6T

Breast Cancer, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0166 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

301

275

259

254

TMB value

8.98

8.20

7.73

7.58


7. tTMB-P7(6.83) Reference Standard CBP80001-7

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0157

CBP80001-7N

B lymphoblast, Female

500x WES

Same individual



DC198N0156

CBP80001-7T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M,CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0156 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

229

218

208

201

TMB value

6.83

6.50

6.21

6.00


8. tTMB-P8(27.15) Reference Standard CBP80001-8

Sample ID

Cat.No.

Background

Assay

Comments

DC198N0165

CBP80001-8N

B lymphoblast, Female

500x WES

Same individual


DC198N0164

CBP80001-8T

Ductal breast carcinoma, Female

500x WES

IDT xGenExome Research Panel v1.0capture,Target Region 39M, Probe Region 51M, CDS Region 33.52M;

HiSeq X-TEN,af choose 0.02 cut off,Filter again.

DC198N0164 is 100% Tumor sample.


Cut off =2%

Cut off =3%

Cut off =4%

Cut off =5%

Mutation Number

910

840

766

685

TMB value

27.15

25.06

22.85

20.44



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