Clinical Research On-Demand:

Many important research questions cannot be studied under controlled circumstances. Events like natural disasters or disease exposure often occur without warning and prevent in-person clinic visits, making timely observation difficult without a flexible approach. At the University of Washington, researchers are partnering with Tasso to study these scenarios by deploying on-demand remote testing.

The human impacts of wildfire smoke exposure are difficult to study in real time. When a fire does strike, people in range must take care to secure the safety of their family, pets, and belongings and cannot travel to a hospital or lab to take part in a clinical research study. Dr. Ashleigh Theberge, Assistant Professor at the University of Washington, was searching for a better way to study the health effects of these flash events.

Bringing the Study Home

Theberge knew that a flexible, decentralized approach to sampling would open up many new research possibilities. Remote blood collection was the key, but there were many requirements to balance in order for this methodology to succeed. The remote blood collection technology needed to be easy for subjects to use, quick to deploy, and produce a stable clinical-grade sample. Further, overall user experience needed to be positive in order to encourage completion of the multiple blood collection timepoints required.

“The nature of the studies we are performing—which involve multiple time points and samples collected soon after an exposure—means they cannot be achieved readily using clinic-based blood draws,” explains Theberge, “Tasso was the obvious choice for our remote blood collection method.” Remote blood collection has traditionally meant either mobile phlebotomy or a lancet-based finger stick, both of which have serious drawbacks. Mobile phlebotomy requires an inconvenient appointment and can be prohibitively expensive, while finger sticks yield low blood volumes and a painful user experience. Tasso’s technology was appealing to Theberge because it enables virtually painless blood collection from any geographical location with the simple push of a button, no user training or complex equipment needed. Kits are shipped directly to users and completed samples are shipped back, so participation is possible without ever leaving home. Using Tasso would produce the patient-centric sampling experience and high quality blood sample that the Theberge Lab needed.

The Theberge Lab designed a participant sampling kit, called homeRNA, containing the Tasso-SST and RNA stabilization reagents to use for their study. They have since been able to successfully collect blood samples from study participants exposed to wildfire smoke in multiple states.

A Pandemic Pivot

With the emergence of COVID-19 as a global health threat, research interest in infectious disease exploded. Studying patients that were currently or previously infected was relatively straightforward, but how could the pre-symptomatic phase of a disease be studied? Thanks to their previous investment in designing quickly deployed remote sampling kits, the Theberge Lab was uniquely positioned to investigate. In a study led by Dr. Fang Yun Lim, a postdoctoral fellow in the Theberge group, they recruited individuals that had been recently exposed to COVID-19, often sending homeRNA kits within 1-2 days of exposure.

Looking Ahead

The decentralized study design employed by the Theberge Lab for their wildfire smoke exposure study works perfectly for many other areas of research. Recruitment is easily promoted via social media and is possible across the entire country instead of a small geographical region, dramatically expanding the pool of eligible participants. Blood samples can be collected from anywhere, providing access to underserved populations and previously inaccessible participants. With faster recruitment and deployment than a traditional clinical study, researchers can start getting answers right away.

Tasso and researcher innovations like homeRNA have taken remote sampling a step further, making remote blood collection and processing easier than ever before. With Tasso, the future of clinical research is moving beyond the clinic.