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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

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

 

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