Now that we’ve all lived through the pandemic and gotten remarkably comfortable (or at least familiar) sticking swabs up our noses and swirling chemicals around tubes at home, the benefits of at-home testing are clear. It’s fast, convenient, and we can do it on our own time, when we think it’s important to test.
However, despite the obvious benefits, at-home testing and sampling is still far from the norm in discovery research and clinical trials, which still use lab and clinic visits almost exclusively for blood-based sampling. But we’ve started to change that and wanted to share some insights.
At ImYoo, we’ve heard over and over again, both anecdotally and from industry data, that getting enough, diverse participants matching the right inclusion criteria is one of the biggest costs and bottlenecks of running studies and clinical trials. We’ve experienced this ourselves. In the first phase of ImYoo (late 2021), we were running a local immune baseline study at Illumina Accelerator, where participants came on-site to give their blood. We got great turnout (we were able to get a couple hundred samples banked), but there were two limitations of our study. First, we had a hard time getting diverse participants - the people who have the time and interest to drive to a blood collection event in the middle of the day are a narrow slice of the population. Second, we didn’t see good representation of people with diseases (except for the ME/CFS community, which self-organized and came to give samples, thank you!). Getting samples from lots of people in a specific disease is incredibly challenging when you’re restricted to a single local collection site.
We knew that to reach the scale of samples that is necessary to make novel biological discovery at the timescale of an early-stage startup, we had to transition to a completely at-home, decentralized model. Partnering with clinics and academics was slow and insufficient - any one center wasn’t able to provide the kind of sample flow that we were looking for.
So, we spent our R&D efforts on making sure we could get reliable single-cell gene expression data from an at-home shippable solution, complete with in-transit temperature tracking. In mid-2023, we launched our first fully decentralized study for tracking autoimmune flares. We collaborated with patient advocates and people found us online, either through their patient networks, or through ads on Facebook and Instagram. It was really cool how quickly we could find and connect with people. We were able to find participants with a very specific disease phenotype (active Crohn’s or Ulcerative Colitis, with a certain flare profile). A few months into the study, and we are at a sample velocity that far exceeded what we were able to do with a local study.
In addition to the convenience of at-home, we’re also tapping into the network effects of communities. Patient support communities and the power of social media really can’t be underestimated. In one remarkable example, we decided to expand our study to rheumatoid arthritis in February. We wanted 14 participants. On February 13, Ali DiGiacomo (@anotherdaywithra) thought our study was cool and posted about it. In less than 24 hours, we got over 100 sign-ups. 2 weeks later, participants were recruited and had ImYoo kits on the way to their house. Another week later and we’re banking our first RA samples.
At-home patient sampling is poised to generate data from novel assays at a scale and speed that is unprecedented in the current biomedical research world. As we expand to our next studies - postmarketing surveillance of therapeutic interventions, and pan-autoimmune flares - we’ll showcase the power of novel study designs that leverage the scale and on-demand sampling capability of patient scientists taking action from home.