Diagnostic Test Development

Laboratory scientists within the UNMC Department of Pathology, Microbiology and Immunology are actively involved in the development and evaluation of new diagnostic tests. Services are provided in collaboration with commercial entities or on a contract basis such as for generation of data in support of 510K applications to the Food and Drug Administration (FDA). These projects draw upon not only the extensive experience of our faculty but also the clinical specimen repositories that have been developed. Projects and services are available for anatomic pathology including such technologies as electron microscopy, immunohistochemistry (IHC) and in situ hybridization. Examples include validation of automated instrumentation using antibodies for cancer or infectious disease diagnostics. Our scientists work closely with commercial partners in the development of protocols, including IRB applications and approvals. Work can be performed on site in our Tissue Sciences Facility or through review of material generated by the commercial partner. Examples include evaluation of new chromosome translocation markers. On cytologic preparation and validation of assays for detecting EBV in solid organ transplant specimens. Departmental scientists have also developed novel assays as part of their own research efforts such as the MycoAlign assay for rapid identification of mycobacteria.

Corporate representatives are encouraged to contact our chair, Joseph Khoury, MD, or medical director, Scott Koepsell, MD, PhD, for further information.