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Resources and Experience

Our team evaluates new In Vitro Diagnostic (IVD) devices or assays by comparison to conventional laboratory testing and/or similar molecular or analytic tests.  Additionally, we are actively involved with numerous corporations/investigators in the development or new technologies (alpha, beta, pre-clinical, investigator-initiated studies). Our laboratories also provide services such as reproducibility/precision testing, access to banks of clinical samples/tissue/microorganisms for the evaluation of new technologies, assays, antimicrobials and detection/identification systems. We collaborate with many industrial and academic organizations on any phase of the developmental research and clinical trial process, including expert review of biopsy histopathology or cytology. Our 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).  

Examples of Completed Studies and Clinical Trials

Infectious Diseases
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

Serology
ANAs and ENAs
HIV Testing
Fungal serology and Antigen testing

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

Chemistry
Thyroid assays
Calcitonin
Pre-eclampsia assays
Procalcitonin

Cardiovascular
Troponin Assays

Urinalysis
Automated U/A

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

Point of Care
Glucose and Hb A1c
Lipid assays
Thyroid assays

In Vitro Diagnostic Development and Clinical Trials | 350 West 11th Street, RM 4020 | Indianapolis, IN 46202-4108