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

 

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

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