Molecular Pathology Research Services (MPRS) & Clinical Trials

MPRS Laboratory Mission

To provide high quality, cost effective NGS services in a CLIA’88 certified laboratory in a manner that supports the patient care, research, and education missions of Virginia Commonwealth University.

The Molecular Pathology Research Services (MPRS) specializes in providing Next Generation Sequencing (NGS) services in a CLIA’88 certified laboratory for research, translational research, and clinical trials.

The MPRS laboratory provides the members of the VCU community the opportunity to incorporate the benefits of the complete list of NGS services in their individual research projects.

The MPRS laboratory is housed in the Molecular Diagnostics Laboratory in the Department of Pathology at VCU. This is a state of the art, CLIA certified laboratory that is fully equipped to provide high throughput NGS services. MPRS laboratory has PGM and Proton instruments, automatic nucleic acid extraction robots, liquid handlers, etc.

NGS Services for Researchers

The MPRS laboratory offers a full range of nucleic acid-based tests including NGS services for researchers which include: nucleic acid extraction, nucleic acid quantitation, library preparation, template preparation and sequencing.

The NGS services provided by MPRS are listed in this form.

Investigators who will be using human tissue need to bring the corresponding form signed by the IRB approved research protocol.

The Division of Molecular Diagnostics provides an extensive number of nucleic acid-based tests. Please see list of tests in Clinical Services section.

Clinical Trial Services

The Molecular Diagnostics Clinical Trial Services specializes in providing nucleic acid based testing for clinical studies of new in-vitro diagnostics tests as well as clinical trials that required molecular diagnostics and pharmacogenetic testing.

Resources

The Laboratory is housed in one of the largest and most sophisticated university-based Molecular Diagnostics laboratories in the country.

Our 6,400 square foot lab includes two large testing areas with state-of-the-art equipment, safety features, and office space. The lab operation uses progressive state-of-the-art technologies and procedures to evaluate infectious diseases, inherited disorders, oncogene copy number, and other gene abnormalities.

The use of PCR, Real Time PCR Technology, DNA hybridization, microarray technology, capillary electrophoresis and Next Generation Sequencing techniques are available, as are specific studies in Factor V Leiden, Factor II Polymorphism, T & B Cell Receptor Gene Rearrangement clonality studies, HIV Viral Load Quantitation and Genotyping, HCV Quantitation and Genotyping, CMV, EBV and BKV Quantitation, Fragile X Syndrome, bcr-abl chimeric mRNA Quantitation, Oncogenomics panels by NGS. List of MDx tests

Certifications

The Molecular Diagnostics Laboratory follows strict regulatory guidelines to ensure we provide the highest quality laboratory services.

The Molecular Diagnostics Laboratory maintains a number of national laboratory certifications.

We are certified by the Federal Government under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and are fully accredited by the College of American Pathologists and the American Association of Blood Banks. The quality of our work is continuously monitored by extensive internal quality control and participation in proficiency testing which is administered by multiple external agencies.

The most recent certifications are listed below and available upon request:

The College of American Pathologist (CAP)
The Joint Accreditation Commission for Hospitals (JACHO)

Molecular Diagnostics Laboratory Services also abides by the following global transportation regulations:

International Air Transport Association (IATA) Compliance
US Department of Transportation

Services

Comprehensive, flexible laboratory services

The Molecular Diagnostics Clinical Trial Services has supported a number of different clinical laboratory trials (references upon request).

Study design
Preparation of protocols
Review of Sponsored Protocols
Budget preparation
Generation of documents required for IRB review
Protocol testing
Sample processing and shipping
Nucleic acid isolation from different specimen sources
Data analysis
Generation of testing reports
Alpha and Beta site testing
Clinical molecular diagnostic testing
Pharmacogenetic testing
Assay design

List of MDx tests

Research

Because of our extensive experience in clinical molecular laboratory testing and the availability of considerable University resources at VCU and VCU Health System, we specialize in Molecular diagnostic testing in the areas of:

Inherited disorders
Infectious disease
Hematopathology
Coagulation
Pharmacogenetics
Alpha and beta site testing for new in vitro diagnostic products
Workflow studies
Evaluation of analytical performance characteristics of new in vitro diagnostic products