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Digital innovation

Driving operational improvements and quality of our services

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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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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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Our commitment to customer success is embedded in every facet of our operations.

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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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Digital Innovation

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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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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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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Bioanalytical/ADME services

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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Biomarker analysis

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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Microsatellite Instability Assay

Microsatellite Instability (MSI) assay utilizing multiplex, fluorescent PCR and capillary electrophoresis to enable sensitive detection of five mononucleotide repeat markers

Microsatellite instability (MSI) results from an accumulation of insertion or deletion of repeating units during DNA replication in tumor cells with a deficient mismatch repair (MMR) system. MSI status is associated with response/resistance to certain immune checkpoint inhibitors.

 

IQVIA MSI assay utilizes multiplex, fluorescent PCR and capillary electrophoresis to enable sensitive detection of five mononucleotide repeat markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) in tumor FFPE specimens. Microsatellite instability at two or more mononucleotide loci is interpreted as MSI-High; microsatellite instability at a single mononucleotide locus is interpreted as MSI-Low; no instability at any of the loci tested is interpreted as microsatellite stable (MSS).

Example of Colon Cancer FFPE Tissue Specimen Demonstrating MSI-High Status

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Example capillary electropherogram demonstrating reference, normal profile in normal tissue (upper panel) and MSI-High profile in tumor FFPE tissue (lower panel). New MSI events labeled 1−5 are detected in tumor tissue.

MSI Assay Specifications
Markers BAT-25, BAT-26, MONO-27, NR-21, and NR-24 microsatellite loci
Specimen Requirements Tumor: 3 x 5um FFPE tumor slides or 3 curls or FFPE block or DNA. Minimum 20% neoplastic cellularity required. Normal: either whole blood (1-3 mL, K2EDTA) or tumor FFPE slides with clearly indicated normal tissue area or 3 x 5um normal tissue FFPE slides, curls or block. If H&E stained slide with indicated tumor normal areas is not available, will perform H&E assessment and determine specimen adequacy.
Assay Method OncoMate® MSI Dx Analysis System
System Compatibility Thermo Fisher Scientific SeqStudio Flex
Regulatory Tier RUO, GCP, CAP-CLIA
Deliverables MSI Status report. Exact number of MSI markers available as custom report.

 

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