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Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

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Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

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Driving operational improvements and quality of our services

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Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

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Download our Corporate brochure

We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

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Central laboratories

Meeting the demands of today’s drug, device and diagnostics development environment requires a next generation service provider.
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Digital Technologies

Labmatrix® is an industry-leading solution developed to address some of the biggest challenges related to clinical trial sample management.
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Genomics

We offer a range of genomic laboratory services to support drug discovery, precision medicine and clinical development. Our industry-leading team advances research by delivering scientific insights that help clients maximize the value of their data.
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Discovery Sciences

Our labs bring expertise in protein production, antibody discovery, and immunogenicity to help you select the most promising candidates and reduce risk as you move toward IND-enabling studies.
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Biosciences

One of the world's largest and most respected bioanalytical and ADME laboratory networks. From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies worldwide.
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Specialty immunoassays

a CLIA-certified biomarker testing laboratory developing immunoassays used to quantify protein biomarkers in support of drug mechanism of action, pharmacodynamic, prognostic, and predictive clinical studies across all stages of drug discovery and development.
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Vaccines

Combining cutting-edge technology platforms and state-of-the-art laboratories with over 35 years of clinical vaccine development.
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Digital innovation

We have a dedicated Digital Innovation department focused on driving operational improvements and quality of our services. We’ve helped create agile and impactful solutions across the organization with the underpinnings of traceability, productivity, quality, and efficiency.
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Therapeutic expertise
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Tumor Mutational Burden Analysis

A TMB assay utilizing  a whole exome sequencing (WES) of tumor specimens for reliable quantification of TMB across various tumor indications

Tumor Mutational Burden (TMB) Assay for Response to Immunotherapy

Tumor Mutational Burden (TMB) is a putative biomarker of response to checkpoint inhibitor therapy. Our TMB assay is a component of our comprehensive immuno-oncology assay portfolio and is available for RUO or GCP applications.

Highlights:

  • TMB assay available in two formats: tumor-only specimens or matched tumor and germline control blood specimens.
  • Based on validated WES assay targeting ~60Mb of coding region of the human genome.
  • TMB tumor-only WES method modeled across multiple tumor indications.
  • High quantitative precision (CV% ≤20%) for TMB >2, suitable for TMB analysis across a wide range of cancer indications including those with traditionally low TMB.
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IQVIA Laboratories
TMB (WES)1		 1.5
(N=123)		 2.4
(N=38)		 2.4
(N=100)		 4.6
(N=64)		 8.7
(N=39)		 10.1
(N=258)		 13.2
(N=113)
Published TMB2 1.8
(N=220)		 2.5
(N=1456)		 2.7
(N=543)		 4.5
(N=7758)		 7.2
(N=80)		 9
(N=2102)		 14.4
(N=879)

 

1 Median TMB scores generated from TCGA whole exome sequencing reads through our pipeline
2 Median TMB scores per Chalmers et al., Genome Medicine 2017
3 https://gdc.cancer.gov/about-data /publications/mc3-2017
LGG=Lower Grade Glioma, CHOL=Cholangiocarcinoma, KIRC=Renal Clear Cell Carcinoma, COAD=Colon Adenocarcinoma, BLCA=Urothelial Carcinoma, LUSC=Lung Squamous Cell Carcinoma,
SKCM=Cutaneous Melanoma, BRCA=Breast Invasive Carcinoma, HNSC=Head-Neck Squamous Cell Carcinoma, LUAD=Lung Adenocarcinoma, SKCM=Cutaneous Melanoma; STAD=Stomach Adenocarcinoma

 

TMB assay specifications
Sample Types Tumor tissue (FFPE, fresh frozen or DNA specimens) Normal tissue, optional (PBMC, whole blood or DNA
DNA Requirements 250 ng DNA
Assay Method Whole Exome Sequencing
System Compatibility NovaSeq
Assay Performance >99.9% accuracy of variant calling for variants above 10% allelic frequency Quantitative precision ≤20% CV% across TMB range of 2-32
Deliverables TMB score, FASTQ, BAM, annotated VCF files

 

Immuno Assay Portfolio

 

Our TMB assay is a component of our comprehensive immuno-oncology assay portfolio which includes other assays such as Immune Landscape Signature and Microsatellite Instability.
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