Featured Methods
Offering comprehensive central laboratory services across a wide-range of featured methods to meet your clinical trial needs.
Offering comprehensive central laboratory services across a wide-range of featured methods to meet your clinical trial needs.
Microbiology
Medpace’s central laboratories offer comprehensive microbiology capabilities that support the specific testing required for each study. Our state-of-the-art microbiology suites, located at Medpace’s Cincinnati, OH, and Shanghai, China central lab are equipped with advanced technology and staffed by experienced medical microbiologists, ensuring high-quality and reliable results while adhering to the strictest national and international standards.
By combining traditional microbiological methods with cutting-edge molecular techniques, we deliver comprehensive insights that drive the success of your clinical trials. Our team works closely with Sponsors to design customized testing protocols that meet study requirements, enhancing the efficiency and efficacy of the drug development process. Our labs also maintain strict adherence to regulatory standards and follows Good Clinical Practice (GCP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. For standards, we follow Good Clinical Laboratory Practice (GCLP) and College of American Pathologists (CAP).
Central Lab Services
- Traditional Microbiology
- Quantitative culture and isolation of target pathogens from clinical specimens (cfu/mL; urine)
- Semi-quantitative culture (urine, wound, stool, respiratory, etc.)
- Gram stain
- Organism identification (MALDI-TOF MS and/or biochemical testing)
- Stool EIA Testing
- Clostridioides difficile GDH & Toxin A & B detection
- Enterohemorrhagic E. coli (EHEC) – Shiga toxins 1 and 2 detection
- Campylobacter-specific antigen detection
- Re-Identification of Isolates
- Identification and/or confirmatory identification of isolates
- Susceptibility testing
- Antimicrobial Susceptibility Testing (AST)
- AST methods:
- Broth microdilution (MIC)
- Kirby-Bauer disk diffusion
- E-test
- Agar dilution
- Breakpoint interpretation using CLSI, EUCAST, and FDA breakpoints
- Customized MIC Panels – including research compound versus comparator drugs
- AST methods:
- Mycology
- Culture and isolation of yeasts from clinical specimens
- Identification of yeasts and yeast-like microorganisms
- Antifungal susceptibility testing
- Broth microdilution (MIC) – CLSI Reference Method
- Molecular Characterization
- Syndromic testing (BIOFIRE, GeneXpert, QIAstat)
- Antimicrobial resistance gene detection
- Whole genome sequencing of isolates
Lab Talk: Histology and Anatomic Pathology
Histology & Anatomic Pathology
Medpace histology offers routine and novel pathology services, including tissue processing, sectioning, general and special stains, immunohistochemistry, in-situ hybridization and digital pathology services with ability to perform select assays in a CAP-accredited, CLIA certified laboratory.
Medpace has an experienced histopathology team overseen by board-certified and subspecialty boarded pathologists, PhD-level scientists and certified histotechnologists with combined experience of over 100 years in anatomic and clinical pathology. Medpace has a state of the art histopathology suite located on the US-Cincinnati campus.
Central Lab Services
- Basic Histology Services
- Tissue Processing, Macrodissection
- Staining
- H&E
- Special Stains (Trichrome, Reticulin)
- Whole Slide Digital Imaging
- Histologic Interpretations (local pathology group with subspecialty training and expertise)
- % ROI (surface area) of tumor content
- Continuing to validate new IHC to support clinical trials
- IHC and ISH
- PD-L1 SP263 in NSCLC (non-small cell lung cancer)
- PD-L1 22C3 in NSCLC
- HER2 in BC (breast cancer)
- ER in BC
- PR in BC
- Cluster of Differentiation (CD) markers:
- CD3, CD4, CD8, CD68, CD19, CD20, CD22
- Ki-67
- LAG-3
- FOXP-3
- TIM-3
- HER2 Dual ISH in BC
Key Instrumentation
- Peloris 3 Tissue Processor
- Leica Spectra H&E Stainer
- Leica Bond III IHC Stainer
- Ventana/Roche Benchmark Special Stainer
- Ventana/Roche Benchmark Ultra IHC stainer
- Agilent/Dako Link 48 IHC Stainer
- Leica AT2 Whole Slide Digital Scanner
Related Histology & Anatomic Pathology Insights
Lab Talk: Molecular & Genomics
Genomics & 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, BAL
- 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)
- Respiratory Syncytial Virus (RSV)
- Parainfluenza 1-4
- SARS-CoV-2 (Qualitative/Quantitative)
Key Instrumentation
- Abbott m2000 RealTime Systems
- ABI-3500XL
- ABI-3730XL
- QIAcube Connect MDx
- QIAstat-Dx Analyzer
- Agilent 4200 TapeStation
- Applied Biosystems SimpliAmp Thermal Cyclers
- BioTek Epoch
- Illumina MiSeq
- Illumina NextSeq 550
- Illumina NextSeq 2000
- MagNA Pure
- QIAsymphony
- Qubit 3.0 and 4.0
- Roche cobas z480
- Seqstudio Genome Analyzer
Related Genomics & Molecular Insights
Lab Talk: Flow Cytometry
Flow Cytometry
Medpace has an experienced Multiparametric 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 in-house-validated ready-to-go panels (e.g. TBNK (IVD) and comprehensive blood subset assays (RUO)), we also offer study-specific full customized panels, such as receptor occupancy and small molecular inhibitor assay (up to 40 colors per panel). Medpace has global cell culture capacity to support assays with process controls or stimulate cell (for a specific response). 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
- Sample Types
- Whole blood
- Peripheral Blood Mononuclear Cells (fresh or cryopreserved)
- Bonne Marrow Aspirate
- Cerebral Spinal Fluid
- Available soon: Dissociated tumors/tissues
- Analysis
- Real time
- Batch analysis
- FlowJo, FACSuite, SpectroFlo
- Validation
- Global data harmonization
- CLSI H62 guidelines
- Quality Assurance review
- IVD or RUO assays
- Custom Panels
- Receptor occupancy assays
- Immune cell phenotyping and Immune cell function assays
- CAR T-cell assays (PK and PD)
- Intracellular cytokine assays
- Functional assays
- Ready-To-Go Panels
- TBNK (Whole blood)
- PNH (Whole blood)
- CD34+ stem cell count (Whole blood)
- T Cell exhaustion (Frozen PBMCs)
- CD4/CD8 (Frozen PBMCs)
- NK (Frozen PBMCs)
- DC panel (Frozen PBMCs)
- Monocytes panel (Frozen PBMCs)
- B Cell panel (Whole blood)
- Intracellular cytokines panel (Fresh PBMCs)
- T, B, NK, NKT, Monocytes, DC, ILCs and Basophils (26 Colors on PBMCs)
Key Instrumentation
- BD FACSLyricTM – 10 Colors
- Cytek Aurora (Spectral) – 40 Colors
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
Related Flow Cytometry Insights
Preparative Ultracentrifugation
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 central and bioanalytical laboratories have broad experience in chromatographic assays supporting preclinical studies and Phase I-IV clinical trials.
Lab Services
- Bile Acids
- Drug pharmacokinetics and metabolite profiling
- Fatty Acid Panel
- Hemoglobin A1c (NGSP Level 1 accredited)
- Hormones, including:
- Dihydrotestosterone (DHT)
- Estradiol/Estrone
- Testosterone Total/Free
- Retinyl Palmitate
- 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