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Driving operational improvements and quality of our services

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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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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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WE'RE HIRING

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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MASH and Liver Disease Drug Development

MASH and Liver Disease Drug Development

Metabolic dysfunction-associated steatohepatitis and steatotic liver disease (MASH & MASLD)

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a chronic liver disease, affecting up to 30% of the world population. Its effects range from simple fat accumulation (steatosis) to inflammatorymediated fibrosis or cirrhosis – the most severe form of the disease called metabolic dysfunction-associated steatohepatitis (MASH). It is estimated that 20-25% of MASLD patients will advance to MASH during their lifetime, placing them at significantly increased risk for liver failure or liver cancer.

Our expert team integrates therapeutic insights, state-of-the-art technologies, best-in-class methods and quality systems to optimize your MASLD/MASH study design, assuring high-quality data delivery and regulatory approval.

Scientific expertise

Our scientific experts include pathologists and scientific advisors in liver disease, infectious disease, translational genomics, and soluble protein biomarkers. We have participated in more than 25 hepatology studies in various capacities, and we provide custom product-specific assay support. Through collaboration with our parent organizations, we have a cross-company MASH and MASLD team with solid experience, global CRO expertise, and multiple reference testing services. This Center of Excellence (CoE) in MASH includes:

  • experienced operations
  • data management
  • regulatory support
  • medical teams
  • a MASH network of proven investigators


Innovations in patient identification using proprietary algorithms and data resources assure the completion of a MASH clinical trial on time and within budget.

Experience

We offer an extensive test menu of liver function tests – both standard and custom tests - and the strategic guidance to address your study goals to ensure better outcomes and regulatory approvals.

Resource

MASH and Liver Disease Capabilities Factsheet

As a leading laboratory services organization for trials across the globe, we integrate therapeutic insights, state-of-the-art technologies, best-in-class methods and quality systems to optimize your MASLD or MASH study design, assuring high-quality data delivery and regulatory approval.
Liver biopsy
Non-invasive biomarkers

Liver biopsy - the gold standard

Tissue biopsy diagnosis remains still the gold standard for the assessment of MASLD and MASH. The staging of the most critical component of MASH —fibrosis— is still best done at the microscope with the help of hematoxylin and eosin (H&E) and two special histochemical stains, Masson’s trichrome and a reticulin (silver) stain. Both stains are validated at our laboratories worldwide. Most patients in a clinical trial have an outside diagnosis and staging of MASH. Due to inter-observer variability, the archival tissues often need to be re-evaluated at the central lab to confirm that outside diagnosis. We have several liver-specialized pathologists who have reviewed tens of thousands of MASH cases over the last five years.

Non-invasive biomarkers for MASH

  • We have several composite biomarker tests to evaluate for MASLD/MASH.
  • Genetic factors may play an important role in determining the phenotypic manifestation and overall risk for NAFLD. We perform the testing for these genetic markers.
  • We offer the Enhanced Liver Fibrosis (ELF™) Test, a blood test to assess the risk of MASLD/MASH progression and liver-related events by measuring three direct markers of fibrosis.

Expertise and insights to optimize your MASLD/MASH study design
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Global capabilities

Our global anatomic pathology services and central laboratory capabilities provide a streamlined operational management structure to ensure continuity and process alignment. We provide the following services to address your testing needs:
  • state-of-the-art technologies
  • quality management systems
  • global capacity
  • high-quality infrastructure
  • project management
  • sample processing
  • long-term sample storage
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Standard assays for liver function
Liver Function/Test Method Aspartate aminotransferase level (AST), Alanine aminotransferase level (AST), GGT, Apolipoprotein, Glucose levels, and Alkaline Phosphatase (ALP) 
Specialized Liver function tests

Hyaluronic acid (HA), PIIINP, TIMP-1, Retinol binding protein-4 (RBP-4), Proc-3, GAL-3, YKL-40

Immunohistochemical Stains:  CytoKeratin 18, Sonic HedgeHog (SHH)

Histochemical Stains:  Masson trichrome, Reticulin, Periodic acid-Schiff (with and without diastase), Prussian blue (iron), Orcein (copper), PicroSirius Red (PSR)

Composite noninvasive biomarker tests

Fibrosis-4 score (FIB4), MASLD Fibrosis score (NFS), Enhanced Liver Fibrosis (ELF) Score, Fibro test, NIS4

Genetic markers for NAFLD predisposition

PNPLA3 - Single nucleotide polymorphism (SNP)

TMS6SF2 - Single nucleotide polymorphism (SNP)

Measurement of liver-specific miRNA levels

 miR-122, miR-34a

 

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