ARUP Medical Director Receives Remote and Austere Conditions (RAC) Grant From the University of Utah

Benjamin T. Bradley, MD, PhD, was awarded a $150,000 grant to study the use of a self-collection blood sample device to increase access to hepatitis C virus (HCV) testing in rural Utah counties. The grant is from the University of Utah through its Remote and Austere Conditions (RAC) Grand Challenge initiative.

"This project has the potential to revolutionize patient access to testing in rural areas by lowering the barriers to specimen collection," said Bradley, who is a medical director for the ARUP Institute for Research and Innovation in Infectious Disease Genomic Technologies, High Consequence Pathogen Response, Virology, and Molecular Infectious Diseases. "If successful, it will allow ARUP to reach even more patients and positively impact their lives."

The project uses the Tasso+ self-collection device, which collects microliter capillary whole blood samples. The Tasso+ collection kit can be shipped directly to patients, facilitating remote collection and eliminating the need for patient lab visits.

Before the RAC grant, ARUP partnered with Tasso to validate the use of Tasso+ for blood chemistry testing. The grant will enable ARUP to explore using Tasso+ for infectious disease testing-specifically for HCV.

"Hepatitis C virus can cause lifelong infections in people who don't receive treatment. This eventually leads to liver failure, cirrhosis, or cancer," Bradley explained. "This virus can have pretty big implications for folks who don't receive treatment."

HCV is a chronic infection for those who remain untreated. But there are effective treatments that can cure HCV once it has been diagnosed. One challenge for people living in rural areas is that HCV requires a two-step testing process-an initial screening test and a follow-up confirmatory test-before treatment can begin.

"The missing link for HCV eradication is that we don't have the testing capabilities we need for individuals who live in remote conditions," Bradley said. Patients in rural areas must travel to a lab or hospital for the first screening blood collection, then return home to await results. If the screening returns a positive result, then they must travel back to the hospital for a second blood draw.

"It's just highly inefficient for these people, and you can imagine there's a high rate of attrition. Folks drop out, and results don't get followed up on," Bradley said.

With funding from the RAC grant, ARUP and Tasso will collaborate to study an end-to-end diagnostic solution for HCV testing in remote areas. Bradley said the project aims to answer two primary questions.

First, will the virus remain stable enough in the collection tubes, despite shipping times and harsh temperatures, to be detectable in the laboratory? Second, can the virus be safely inactivated "so that shipping it through standard U.S. mail with normal precautions isn't going to pose a risk to anyone-without the need to develop any additional processes for handling the packages?" Bradley said. "We really want it to be as seamless as possible and built on as much existing infrastructure as possible."

Additionally, optimized testing processes will require only one patient sample instead of two. "We will take that single microliter blood sample and optimize our lab processes to be able to do the screening test and the confirmatory test on that same sample," Bradley explained. "So, it takes a single blood draw that doesn't require travel to the hospital."

Bradley called the project a proof-of-concept study that, if successful, will open the door to additional uses of the Tasso+ device, such as viral load monitoring for people with human immunodeficiency virus (HIV) or cytomegalovirus (CMV) monitoring for transplant patients. "To be able to do all that testing and monitoring without having patients travel could really be a huge benefit to them," he said.

Through ARUP's previous studies with Tasso, "we've demonstrated that the device works very well, even though it's a micro collection device," said Robert Ohgami, MD, PhD, FCAP, vice president for the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™ (R&I Institute).

"We've been able to demonstrate that for certain molecular testing and for certain chemical analytes, you don't need anything beyond those smaller volumes. It's exciting that we're now able to expand utilization of the device to other areas-in particular for infectious diseases."

The HCV project is a notable example of the valuable collaborations ARUP is forming through the R&I Institute. "The mission of the R&I Institute is to be at the cutting edge of diagnostic clinical lab medicine in partnership with industry and academic groups," said Ohgami. "That is exactly what this grant accomplishes. It's connecting ARUP's laboratory capabilities and infectious disease expertise with a fantastic startup company that has novel, cutting-edge technology. Together, that partnership is going to make a broader impact on infectious disease medicine."

Heather Stewart, [email protected]

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