Organ transplants, cancer treatments, and therapies for chronic diseases all require repeated blood tests to monitor levels of drugs and organ function. Frequently drawing blood from a vein becomes increasingly painful, technically difficult, and potentially traumatizing—especially for children. It is also expensive.
In 2016, a record-breaking 33 thousand organ transplants were performed in the United States. An estimated 250,000 recipients of organ transplants performed since 1987 are still living. These individuals will have about 48 tests done in the year following the transplant and about twice a year from then on. These clinic visits total more than 1.3 million each year.
Costs associated with these visits are significant, and not only from a clinical standpoint. Caretakers miss time from work and children accumulate absences at school. A method for collecting blood samples at home could dramatically reduce costs, time, and associated stress. It also could lead to better compliance with drug regimens and reduced rates of rejections of organs. A team of OHSU researchers has developed, tested, and modified a prototype of such a device. The team is preparing for a study on the modified prototype
Amira Al-Uzri, M.D., a pediatric nephrologist in the Doernbecher Children’s Hospital, was part of a team that, three years ago, began developing the prototype of a device that could change the landscape of post-transplant blood testing. A number of devices have been introduced to the market, but none have proven to be practical for wide-scale use in children. The goal is a device that is accurate enough to substitute for about 60 percent of clinic visits each year. That’s more than 800,000 clinic visits. The prototype has now been tested, modified, and the team is preparing for a study on the modified prototype.
The team included co-investigator Al-Uzri, principal investigator Dennis Koop, Ph.D., professor of physiology and pharmacology at the School of Medicine, and co-investigator Andrew Chitty, program director of University Shared Resources.
The device, called TouchSpot, uses dried blood spot sampling, a technique in which a small amount of blood from the finger or heel is drawn and then dried before analysis. In order to serve as an alternative to venipuncture, a precise amount of blood must be delivered to filter paper. Collecting a precise quantity of blood and preventing damage to the filter paper are primary challenges to developing a dried blood spot sampling device that can stand in for intravenously collected samples.
The TouchSpot prototype was tested with pediatric oncology patients attending the Survivorship clinic at the Doernbecher Children’s Hospital. Al-Uzri’s team worked with children and their families to collect dried blood spots to be used in tests of kidney function. Based on the preliminary results of the study, the team is introducing modifications to the TouchSpot design, including improvements to the structure that will make the filter paper easier to dry and to remove from the device for lab analysis. The modifications also will make the device easier for use in children.
The research team’s concept for a device that could change the lives of pediatric patients—and their parents—has moved from prototype to a more advanced design. The next step is to evaluate the improved design. Al-Uzri expects to then have the data for a strong grant application to the National Science Foundation.
The Oregon Clinical and Translational Research Institute‘s Biomedical Innovation Program funded development of the prototype. Evaluation of the device was funded by a pilot grant program through University Shared Resources and the Office of the Vice President for Research. The Bioanalytical Shared Resource Pharmacokinetics Core analyzed the samples and the revisions to the prototype were made possible by funding from The Friends of Doernbecher. Other members of the OHSU infrastructure are helping move the device from prototype to commercial use. The collaborative OHSU and industry effort has included the Office of Proposals & Award Management, Technology Transfer & Business Development patent team and industry partners Simplexity Product Development and Allegory Venture Partners.