In Vitro Diagnostic Development and Clinical Trials

Laboratories and Facilities

The In Vitro Diagnostic Development and Clinical Trials Group research and development (R&D) and Clinical Research Team is housed in the Indiana University Health Pathology Laboratory and at Sidney and Lois Eskenazi Hospital, both in downtown Indianapolis.

IU Health Pathology Laboratory

IU Health Pathology Laboratory is a regional reference lab serving 10 major hospitals as well as multiple smaller hospitals, clinics and outpatient facilities. This state-of-the-art central laboratory is located on the canal in downtown Indianapolis and performs more than 13 million lab tests annually and provides the most comprehensive lab services in Indiana. Accredited by CAP, CLIA and AABB.

Sidney and Lois Eskenazi Hospital

The Sidney and Lois Eskenazi Hospital is an energy-efficient, environmentally advanced hospital and laboratory, representing the largest safety net health system in Indiana. This hospital laboratory performs about 1.5 million tests each year and serves the vulnerable populations of Marion County in Indianapolis. Accredited byJCAHO, CAP, CLIA and AABB.

The following methodologies/ technologies, approximate annual test volumes, and instrumentation/assays are utilized by the In Vitro Diagnostic Development and Clinical Trials Group.

Blood cultures (94,000), urine/wound/respiratory (150,000/20,000/15,000), mycology/parasitology (14,000/5,000), TB (10,000), virology cultures (2,000).

BACTEC, Vitek, Bruker Maldi-TOF, VIDAS, WASP, FilmArray, Verigene, PNA FISH, Cepheid, Hologic, DiversiLab

Tumor markers (5,000), viruses (35,000), STD (65,000), genetics, coagulation.

BD, Hologic, Roche, Cepheid, GenMark, Luminex, Focus, Illumigene, Illumina, Immucor, BioMerieux, Promega, Qiagen, ABI, Abbott, Invivoscribe, Agilent

Metabolic analytes (300,000), blood gases, protein and immunofixation electrophoresis (20,000), mass spectrometry.

Beckman-Coulter, Siemens, Gem 4000, Abbott, ImmunoCAP, Agilent

Blood counts (250,000), Urinalysis (50,000), Flow cytometry.

Beckman Coulter, IRIS

PT/INR (120,000), special coagulation assays.


Type and cross match (10,000); antibody identification (20,000).

Immucor NEO/Echo, Ortho Clinical Diagnostics, Haemonetics TEG

Cytology (57,000-gynecologic and 8,500 non-gynecologic), Fine-needle aspirates (4,500), biopsies (89,000), Immunohistochemical stains, In-Situ Hybridization. Digene