Point-of-Care Multiplexed Immunosuppressant Monitoring

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Project Summary Approximately 24 million Americans require long-term immunosuppressive therapy/treatment, either due to an autoimmune disease or because they recently had a transplant, solid organ or bone marrow. The goal of immune suppression is to administer the minimum effective dose to prevent the immune system’s attack on the patient’s own tissue in the case of an autoimmune disease or prevent organ rejection in the case of a transplant, without leaving the patient dangerously vulnerable to infection. Research has shown there is a narrow window of therapeutic concentrations for immunosuppressive drugs in blood that is safely effective for a given patient and unfortunately, different patients can require dramatically different dosages to reach that optimal level. Complicating the matter further is the fact that drug levels must be measured at precise intervals after dosing to account for differences in the rates of metabolism from patient-to-patient. Unfortunately, the current technology for measuring these drug levels requires large blood draws that are only available in centralized lab facilities. So, in practice, immunosuppressive drug monitoring is logistically complicated and burdensome, in addition to being inconvenient and largely inaccessible for patients, who must: 1) arrange transportation to a blood draw clinic or transplant center, which may be hundreds of miles from home; 2) take a dose and wait around for hours for the drugs to enter their bloodstream; and/or 3) have several these blood draws. This process is unfeasible for routine drug monitoring. Electronic BioSciences, Inc. (EBS) proposes to develop a new method, based on the latest advances in nanopore technology, for the monitoring of immunosuppressive drugs. The advantage of the developed technology is that it will be as easy to obtain and use as a fingerstick glucose test. This will in turn enable readily available, routine immunosuppressive drug monitoring for these patients, at hospitals, transplant centers, outpatient clinics, or even at home. More frequent monitoring of immunosuppressive drug levels at specific time intervals will result in more accurate dosing, and consequently fewer life-threatening infections and/or episodes of organ rejection. Until a fast, easy, inexpensive test for immunosuppressive drug monitoring is developed, patients will be unnecessarily burdened and at risk, and doctors will continue to be in the dark when trying to correctly dose these drugs.