Featured Methods

Genomics and Molecular Assays

Testing a subject for specific genomic biomarkers can provide insight into risks for various disease states or predict response to specific treatment approaches and enable clinicians to provide personalized treatment. Pharmacogenomics (PGx) examines the genetic differences in drug metabolic pathways which can affect a subject’s response to therapeutics.

Medpace has an experienced molecular/genomic team overseen by PhD-level scientists and bioinformatics scientists with over 20 years of experience designing, analyzing, and interpreting molecular and genomic testing.

Medpace has state of the art molecular suites and cell culture labs at the US and Belgium laboratory locations.

Central Lab Services

DNA Extraction (Concentration, Purity, Yield) Next-Generation Sequencing Viral Testing by qPCR
RNA Extraction (Concentration, Integrity, Yield)          B cell / T cell receptor repertoire profiling          CAR-T cell therapy studies
PBMC Processing (Cell count and Cell viability)          Small and large gene panels (Familial Hypercholesterolemia, Myeloid panel, DNA Damage Repair, etc)          Gene Therapy studies
Companion Diagnostics          Pharmacogenomics (PGx)          Organ and HSC transplant studies
Sanger Sequencing          Exome sequencing          Viral Shedding
         Single gene sequencing or single mutation Genotyping          Whole genome sequencing          Viral Loads in multiple sample types including serum, plasma, PBMC, stool, CSF, urine
         Fragment Analysis          Germline and somatic mutations for all disease types                   Adenovirus (ADV)
         Germline mutations for all disease types          Liquid Biopsies (Cell free DNA by NGS or digital PCR)                   Cytomegalovirus (CMV)
         MLPA for gene copy number determination          Micro Satellite Instability (MSI) and Mismatch Repair (MR)                   Epstein-Barr Virus (EBV)
         NGS validation          Minimal Residual Disease (MRD)                   Hepatitis B Virus (HBV)
Recombination Competent Retrovirus (RCR), Recombination Competent Lentivirus (RCL) & Viral Infectivity in support of:          RNAseq gene signatures                   Hepatitis C Virus (HCV) Qualitative / Quantitative)
         CAR-T cell therapy studies          Tumor mutation burden for Immunotherapy studies                   Human Herpesvirus 6 (HHV6)
         Gene Therapy studies          Gut Microbiome and Metagenomic Sequencing (Shotgun and 16S ribosomal RNA sequencing)                   Influenza Type A
         TCR-based therapies          Bioinformatics data analysis                   Metapneumovirus (MPV)
                  Polyomavirus BK (BKV)
                  Polyomavirus JC (JCV)
                  RSV
                  Parainfluenza 1-4

Key Instrumentation

Abbott Molecular m2000 Illumina MiSeqDx Qubit 3.0 and 4.0
ABI-3500XL Illumina NextSeq 550 Roche cobas 4800
Aligent 4200 TapeStation Magnapure Seqstudio Genome Analyzer
Applied Biosystems SimpliAmp Thermal Cycler

Genomics and Molecular Resources

Articles

Expert Insights: Molecular Genomics Profiling and the Future of Clinical Trials

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ACC 18 Poster

Scientific Posters and Publications

Detection of Familial Hypercholesterolemia in South Africa via Cascade Screening: The Wits Find-FH...

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Whitepapers

Whitepaper: The Current Biomarker Landscape in Immuno-Oncology

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Flow Cytometry

Medpace has an experienced flow cytometry team overseen by PhD-level scientists with over 10 years of experience designing, analyzing, and interpreting multicolor flow cytometry assays. In addition to those in-house-validated ready-to-go panels (e.g. TBNK), we also offer study-specific full customized panels up to 10 colors (soon to be expanded to 20). Whether a custom panel needs to be developed or a method needs to be transferred to our laboratory to support a global clinical trial, we have the experience to quickly validate and implement the flow cytometry testing.

Medpace has global flow cytometry capabilities at the US, Belgium, and Singapore laboratories.

Central Lab Services

Analysis on sample types: whole blood, CSF, human bone marrow aspirate, and PBMCs Intracellular cytokine assays
CAR T-cell assays (PK and PD) Receptor occupancy assays
Intracellular measurement of second messengers (e.g. CAMP, Mg2+ and Ca2+) Receptor functional assays (such as phosphorylation – phosphoFlow)
Immune cell, rare cells, progenitor enumeration PNH assay (CAP PT)
Immune cell phenotyping and Immune cell function assays TBNK assay (CAP PT)
Our service is always bundled with High-Parameter analysis (FlowJo, FACSuite, FACSDiva)

Medpace has a strategic lab partnership that has extensive experience performing flow cytometry hematomalignancies, LAIP (leukemia-associated immunophenotypes), and MRD (minimal residual disease) analysis requiring a pathologist review and interpretation.

Key Instrumentation

BD FACSLyricTM – 10 Color

Therapeutic Indications Supported

Autoimmune Diseases and Allergy Oncology-Hematology
Cardiovascular Diseases and Pulmonary Diseases          Solid Tumors
Hematology          Leukemia
Inflammatory-Infectious Diseases          Lymphoma
          COVID-19          Multiple Myeloma
AIDS         Squamous Cell Carcinoma

Flow Cytometry Resources

Whitepapers

Whitepaper: Flowing with the Translational Trend

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Articles

Expert Insights: Flow Cytometry: Its Role in Clinical Trial Biomarkers

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Case Studies

Case Study: A Phase I Clinical Receptor Occupancy Assay by Flow Cytometry

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Case Studies

Case Study: A Phase I Clinical Receptor Activation Assay by Intracellular Flow Cytometry

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Whitepapers

Whitepaper: Flow Cytometry Techniques

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Preparative Ultracentrifugation (PUC)

Preparative ultracentrifugation (PUC) is the gold standard method for lipoprotein fractionation. Medpace labs is the “go-to” lab for PUC analysis for drugs in development, with capability for this very specialized and technically difficult testing in all four Medpace global central lab locations for low-density lipoprotein and other lipoprotein classes. Medpace performs PUC in high volume with over 2,000 analyses monthly.

PUC testing isolates the following lipoproteins, allowing the quantification of cholesterol, triglycerides, apolipoproteins (AI, AII, AIV, B48, B100, CII, CIII, E), phospholipids, fatty acids, and other lipid specific analytes.

Lipoprotein Fractions Isolated

Chylomicron Fraction LDL(Low Density Lipoprotein) Fraction
VLDL (Very Low Density Lipoprotein) Fraction HDL (High Density Lipoprotein) Fraction
IDL (Intermediate Density Lipoprotein) Fraction HDL Sub-fractions HDL2 and HDL3

PUC Scientific Posters Presented by Medpace

Scientific Posters and Publications

Friedewald Formula Significantly Underestimates LDL Cholesterol Compared to Preparative Ultracentrifugation below 70 mg/dL...

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Scientific Posters and Publications

Accurate Assessment of LDL Cholesterol Reduction at Levels Below 70mg/dL Has Implications in...

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Scientific Posters and Publications

Underestimation of LDL Cholesterol Below 70 mg/dL (1.8 mmol/L) by Friedewald, Hopkins and...

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Scientific Posters and Publications

LDL Cholesterol Reduction with BMS-962476, An Adnectin Inhibitor Of PCSK9: Results Of A...

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Chromatography

Medpace laboratories (central and bioanalytical labs) have broad experience in chromatographic assays supporting preclinical studies and Phase I-IV clinical trials.

Laboratory Services

Key Instrumentation
Bile Acids Nutritional Biomarkers, including AB Sciex 4000, 5500, 5600, and 6500 LC-MS/MS
Drug pharmacokinetics and metabolite profiling   Alpha Carotene Shimadzu 060 LC-MS/MS
Fatty Acid Panel   Beta Carotene Shimadzu GCMS-QP2010
Hemoglobin A1c (NGSP Level 1 accredited)   Vitamin A Tosoh G7
Retinyl Palmitate   Vitamin B Tosoh G8
Hormones, including:   Vitamin 25 OH D2and D3 Waters AcQuity UPLC
  Dihydrotestosterone (DHT)   Vitamin E Waters Xevo TQ-XS LC-MS/MS
  Estradiol/Estrone   Vitamin K1 and K2
  Testosterone Total / Free

Resources

Services and Capabilities

At-A-Glance: Central Laboratories

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Services and Capabilities

Fact Sheet: Central Laboratories

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Services and Capabilities

Fact Sheet: Medpace Labs and IHMA

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Services and Capabilities

Video: Expect More from Your Central Lab

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Webinars

Webinar: Challenges and Considerations in Designing and Conducting Immuno-Oncology Clinical Research

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Articles

Article: Non-statin Treatments for Managing LDL Cholesterol and Their Outcomes

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Whitepapers

Whitepaper: The Current Biomarker Landscape in Immuno-Oncology

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Whitepapers

Whitepaper: Non Invasive Biomarkers Of Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

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A Central Laboratory Interlaboratory Comparison Program to Assess the Comparability of Data of Forty-one Tests from Four Regional Laboratories Involved in Global Clinical Trials over a Twelve Month Period

Whitepapers

Whitepaper: A Central Laboratory – Harmonization of Data

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Whitepapers

Whitepaper: Effect of Hemolysis, Icterus and Lipemia on Chemistry Tests and Association between...

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Whitepapers

Whitepaper: Flow Cytometry Techniques

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Articles

Article: Understanding Regulation and Validation Processes for Biomarkers

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