SBIR Phase II: A Novel Device for Convenient Therapeutic Drug Monitoring of Tacrolimus

This Small Business Innovation Research (SBIR) Phase II project is aiming to develop and validate a point-of-care monitoring for tacrolimus, an immunosuppressive medication widely used by organ transplant patients. The product being developed combines the existing, well-developed and low cost glucose meter technology with the gold standard immunoassay platform, leading to a product that can potentially improve the treatment outcome of transplant patients. Currently, monitoring of tacrolimus level is achieved by using laboratory assays, which has a long turn-around time and frequent monitoring is more difficult. However, tacrolimus is a drug whose toxic level is only couple times higher than its therapeutic level, and current infrequent monitoring approach is less effective to ensure the most effective drug levels in patients. The Phase II project will be achieved by first optimizing the glucose meter based tacrolimus assay developed in Phase I, following by the development and validation a disposable device which will house the assay and a glucose monitor which has an improved sensitivity. We anticipated the system composed of a disposable and a reader will be developed and validated at the end of the Phase II project, preparing the technology for clinical validation. The broader impact/commercial potential of this project lies in the future development of the technology that will expand the potential test targets beyond tacrolimus. Numerous drugs currently on the market have a narrow therapeutic range, as well as many effective drugs that cannot be marketed due to lack of close monitoring methods to reduce their toxic effects. The innovative therapeutic drug monitoring device we are developing will allow many of these drugs become more available. For our current target market, with hundreds of thousands of transplant patients using tacrolimus worldwide for the remainder of their lives, the commercial potential for our product is immense. The social impact is considerable, and for just kidney transplants, 29% of the allografts will fail in the next five years due to improperly managed immunosuppressant medications costing hundreds of millions of dollars for post failure treatment and dialysis. Providing patients with a convenient tool to manage their medication can significantly reduce the number of failed kidneys, leading to better life to the patient and huge savings for the society.