Molecular Diagnostics Clinical Trials
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.
Mission & Vision
Our Mission is to provide high quality, cost effective molecular pathology services in a manner that supports the patient care, education, and research missions of the Virginia Commonwealth University Health System and School of Medicine.
Our Vision is to become a preeminent Department of Pathology in the United States, which is recognized for excellence in biomedical research, the education of health care professionals, and the innovative application of science and technology to the diagnosis and management of human disease.
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. click here for a list of MDx tests
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
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
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
- Alpha and beta site testing for new in vitro diagnostic products
- Workflow studies
- Evaluation of analytical performance characteristics of new in vitro diagnostic products
Molecular Diagnostics Laboratory
Clinical Support Center