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)
- RNA Extraction (Concentration, Integrity, Yield)
- PBMC Processing (Cell count and Cell viability)
- Companion Diagnostics
- Sanger Sequencing
- Single gene sequencing or single mutation Genotyping
- Fragment Analysis
- Germline mutations for all disease types
- MLPA for gene copy number determination
- NGS validation
- Recombination Competent Retrovirus (RCR), Recombination Competent Lentivirus (RCL) & Viral Infectivity in support of:
- CAR-T cell therapy studies
- Gene Therapy studies
- TCR-based therapies
- Next-Generation Sequencing
- B cell / T cell receptor repertoire profiling
- Small and large gene panels (Familial Hypercholesterolemia, Myeloid panel, DNA Damage Repair, etc)
- Pharmacogenomics (PGx)
- Exome sequencing
- Whole genome sequencing
- Germline and somatic mutations for all disease types
- Liquid Biopsies (Cell free DNA by NGS or digital PCR)
- Micro Satellite Instability (MSI) and Mismatch Repair (MR)
- Minimal Residual Disease (MRD)
- RNAseq gene signatures
- Tumor mutation burden for Immunotherapy studies
- Gut Microbiome and Metagenomic Sequencing (Shotgun and 16S ribosomal RNA sequencing)
- Bioinformatics data analysis
- Viral Testing by qPCR
- CAR-T cell therapy studies
- Gene Therapy studies
- Organ and HSC transplant studies
- Viral Shedding
- Viral Loads in multiple sample types including serum, plasma, PBMC, stool, CSF, urine
- Adenovirus (ADV)
- Cytomegalovirus (CMV)
- Epstein-Barr Virus (EBV)
- Hepatitis B Virus (HBV)
- Hepatitis C Virus (HCV) Qualitative / Quantitative)
- Human Herpesvirus 6 (HHV6)
- Influenza Type A
- Metapneumovirus (MPV)
- Polyomavirus BK (BKV)
- Polyomavirus JC (JCV)
- RSV
- Parainfluenza 1-4
Key Instrumentation
- Abbott Molecular m2000
- ABI-3500XL
- Aligent 4200 TapeStation
- Applied Biosystems SimpliAmp Thermal Cycler
- Illumina MiSeqDx
- Illumina NextSeq 550
- Magnapure
- Qubit 3.0 and 4.0
- Roche cobas 4800
- Seqstudio Genome Analyzer
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
- CAR T-cell assays (PK and PD)
- Intracellular measurement of second messengers (e.g. CAMP, Mg2+ and Ca2+)
- Immune cell, rare cells, progenitor enumeration
- Immune cell phenotyping and Immune cell function assays
- Our service is always bundled with High-Parameter analysis (FlowJo, FACSuite, FACSDiva)
- Intracellular cytokine assays
- Receptor occupancy assays
- Receptor functional assays (such as phosphorylation – phosphoFlow)
- PNH assay (CAP PT)
- TBNK assay (CAP PT)
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
- Cardiovascular Diseases and Pulmonary Diseases
- Hematology
- Inflammatory-Infectious Diseases
- COVID-19
- AIDS
- Hematology-Oncology
- Solid Tumors
- Leukemia
- Lymphoma
- Multiple Myeloma
- Squamous Cell Carcinoma
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
- VLDL (Very Low Density Lipoprotein) Fraction
- IDL (Intermediate Density Lipoprotein) Fraction
- LDL (Low Density Lipoprotein) Fraction
- HDL (High Density Lipoprotein) Fraction
- HDL Sub-fractions HDL2 and HDL3
Chromatography
Medpace laboratories (central and bioanalytical labs) have broad experience in chromatographic assays supporting preclinical studies and Phase I-IV clinical trials.
Laboratory Services
- Bile Acids
- Drug pharmacokinetics and metabolite profiling
- Fatty Acid Panel
- Hemoglobin A1c (NGSP Level 1 accredited)
- Retinyl Palmitate
- Hormones, including:
- Dihydrotestosterone (DHT)
- Estradiol/Estrone
- Testosterone Total/Free
- Nutritional Biomarkers, including:
- Alpha Carotene
- Beta Carotene
- Vitamin A
- Vitamin B
- Vitamin 25 OH D2and D3
- Vitamin E
- Vitamin K1 and K2
Key Instrumentation
- AB Sciex 4000, 5500, 5600, and 6500 LC-MS/MS
- Shimadzu 060 LC-MS/MS
- Shimadzu GCMS-QP2010
- Tosoh G7
- Tosoh G8
- Waters AcQuity UPLC
- Waters Xevo TQ-XS LC-MS/MS
