In Vitro Diagnostics Development and Clinical Trials

In Vitro Diagnostics Development and Clinical Trials

The In Vitro Diagnostics Development and Clinical Trials Group offers integrated services for every stage of clinical research – from development to commercialization. A results-driven academic enterprise, this group provides professional clinical laboratory medicine expertise for the laboratory diagnostics industry. The group’s clinical footprint and centralized laboratory affords near limitless resources for the evaluation of developing clinical laboratory technologies.

Services

The In Vitro Diagnostics Development and Clinical Trials Group team evaluates new In Vitro Diagnostic (IVD) devices or assays by comparison to conventional laboratory testing and/or similar molecular or analytic tests. Available services include reproducibility/precision testing, access to banks of clinical samples/tissue/microorganisms for the evaluation of new technologies, assays, antimicrobials and detection/identification systems. The research team is comprised of personnel that are ACRP/SOCRA certified with many years’ experience in all phases and processes for conducting clinical research (GCPs, IRB submissions, contract negotiations).

Partnerships

The In Vitro Diagnostics Development and Clinical Trials Group is actively involved with numerous corporations/investigators in the development of new technologies (alpha, beta, pre-clinical, investigator-initiated studies), collaborating with industrial and academic organizations on any phase of the developmental research and clinical trial process, including expert review of biopsy histopathology or cytology.

Examples of Completed Studies and Clinical Trials

Whole Blood Detection and Identification of Bacteria, Viruses, and Fungi
Blood and Body Fluid Culture Systems
Evaluation of Liquid and Solid Media for Recovery and Identification of Microorganisms
Phenotypic Identification and Susceptibility Testing of Microorganisms
Molecular Identification of Microorganisms and Resistance Markers
Identification of Bacteria, Fungi, Mycobacteria and Viruses by PCR, Real-time PCR and other Molecular tests
Evaluation of “Syndromic” Molecular Panels for Identification of Microorganisms
Traditional virus culture and Viral Load determination by molecular methods

ANAs and ENAs
HIV Testing
Fungal serology and Antigen testing

Cervical and Anal Cancer Screening (HPV-related) by Molecular Methods and Biopsy Interpretation
Tumor-associated antigens
Tumor metabolomic markers
Tumor genetic markers

Thyroid assays
Calcitonin
Pre-eclampsia assays
Procalcitonin

Troponin Assays

Automated U/A

HIT (Heparin-induced Thrombocytopenia)
PEG
PT, PTT, Thrombin factor deficiencies
Anti-thrombin

Glucose and Hb A1c
Lipid assays
Thyroid assays