Studies to Support Clinical Trials
The research team at IST has been conducting research and development to support clinical trials for many years. IST is currently involved in clinical trial research on a number of fronts. The IST team has more than 110 years of IVD product development and ISO9001:13485 manufacturing experience with over 200 successful diagnostic product reagents, kits, and instrument systems.
At IST’s GLP-compliant laboratories, automated assays for vaccine and/or biologics development are performed within tight specifications yielding precise and accurate findings with a fast turnaround time. This helps IST to ensure that the data collected on clinical trial patient samples are of the highest quality to support pharma investigations. Additionally, these types of assays have successfully been used to follow drug candidates through all phases of clinical trials over periods as long as 18 to 24 months, and may emerge as a companion diagnostic for therapeutic stratification or monitoring. 
IST has been chosen by world-class clinical trial and research organizations to identify and establish controls and calibrators for immune system assays, and to standardize, automate and conduct testing of patient samples from ongoing clinical trials.
As one example, researchers at ImmunoSite Technologies have been selected for numerous grant awards from early 2007 to late 2009 by a prestigious international group of medical researchers known as the CD4 Initiative. The objective of the group is to develop a CD4 cell count test that can be made inexpensively available to millions of HIV-positive people in resource-poor nations. IST has been awarded continued funding by the CD4 Initiative to further develop quality assurance (QA) material for the test, and Zyomyx Inc., a California company, was awarded continued funding to develop a simple, non-electronic, point-of-care device. The QA material is in the clinical trial phase, to ensure that the test device provides results that are accurate and precise.
Principal investigator on the CD4 Initiative project at ImmunoSite Technologies is Sybil D’Costa, Ph.D., VP of research and development. The IST team has successfully developed QA material that works well with the test device, and is continuing to test performance as they move into production.
“The main challenge for our team has been to develop a cell-based, quality assurance reagent that mimics the properties of CD4 T cells in whole blood, and will operate properly and consistently in elevated temperatures, such as those common in sub-Saharan Africa and similar countries,” said Dr. D’Costa.
Key to the success of the IST team is their extensive expertise in cellular analysis, cellular quality control material development, and assay development. Dr. D’Costa has worked together with Wade Bolton, Ph.D., president and CEO of IST, for almost 10 years developing assays for immune system monitoring and surveillance. Both previously worked together in the Custom Biopharma Solutions division at Beckman Coulter Inc., a world leader in clinical diagnostics, developing innovative cellular analysis products and reagent systems.
