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When we started ImYoo, we recognized a need to connect patients in their own pursuit of health with medical researchers and clinicians trying to help them. In our original 2020 Nature Scientific Reports paper we wrote “our platform makes collection and profiling of human immune cells less invasive, less expensive and as such more scalable than traditional methods rooted in large venous blood draws.”


(Image source: Science News)

Today, that idea is now a growing trend as recognized by this month’s feature article in Science News. Here’s an excerpt with a quote from CEO and co-founder Tatyana Dobreva:


“Study designs informed by patient experience often prioritize accommodations for people with different levels of symptoms or access to care, meaning a more diverse group of patients may be able to participate. With a patient led, ‘decentralized’ approach to research, ‘we can reach more people in more diverse areas’ who don’t live near medical facilities in big cities or aren’t able to travel for clinical trials, Dobreva says."


You can read the full article here.


“Patient scientist” is how we refer to our study participants - because they're not subjects, they're the experts of their lived experience, and they have to think critically to actively participate in discovery. Every patient has the goal to shed the patient label and become healthy again. Active participation in the greater scientific knowledge discovery process is one way to do that. And what we’ve learned is that when you remove the requirement of visiting a clinic to draw a blood sample and it’s coupled with high throughput single-cell analysis, we can amass greater knowledge from more diverse populations faster and with higher completion rates.


Last year, the FDA took note: “Decentralized clinical trials and digital health technologies are gaining momentum in medical research, allowing research participants to partake in trials remotely using state-of-the-art digital health technologies.”  The FDA also issued further guidance in support of decentralized trials to spur greater and more diverse patient participation. 


Geography, time and cost are the causes of major blindspots in traditional approaches to medical research. The clinical trial you could be eligible for is either in your area or it’s not. “Location” is one of the major search parameters on clinicaltrials.gov for this precise reason. You either can make time to visit a clinic repeatedly for sample collection, or you can’t. Logistics and proximity matter a lot. And of course clinics are expensive to maintain and operate.  So as a result, we simply do not collect enough data from enough people consistently to generate the data needed to drive insight and accelerate discovery. 


But that’s what we’re changing along with all our patients and partners. By prioritizing patient access, ImYoo removes the variables of location and time while lowering sampling and analysis costs. The future of medicine is at home in the growing numbers of patient scientists who are now driving smarter and faster biomedical research.


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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.

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We're halfway to meeting our recruitment goals, but we need your help!


We’re excited to release our first progress report for the inflammatory bowel disease (IBD) Flare Study since launching in June! We are at the recruitment halfway point but we need your help to finish enrolling this study.


The sooner we finish enrolling this study, the sooner we can return everyone’s results and share our findings! And did we mention we are now compensating patients who participate in the study? That’s right, we’re committed to sharing value with patients and proud to finally have the green light to do so!


How can you help?


We are looking to enroll IBD patients currently experiencing active flares.


  • Share the ImYoo IBD Flare study with your community, on social media, with your neighbor - help us get the word out!

  • See someone post about being in a flare? DM them to let that person know that they're not alone and that we've got this research study for them to join

  • You can direct interested individuals to imyoo.health/ibd

  • Share my direct email, happy to connect 1:1. emilyharari@imyoo.health

How does the ImYoo IBD Flare study work?


A quick summary on how the IBD Flare study works: Each patient will self-collect 6 samples as they experience IBD flare-ups (a group we call “IBD Active”). If they don’t flare during the time period of the study (a group we call the “Control”), they’ll only self-collect 3 samples. One example of a study control is someone in IBD remission. For more context on the study methodology, you can read our first post about the IBD Flare study. To effectively power this study, we need a minimum of 50 participants, but we’re enrolling up to 80. Here’s our progress on enrollment: How many people are enrolled in the IBD Study?



With 30 IBD Active patients enrolled, we are more than halfway to reaching our enrollment goal of 40 participants. With 2 Control patients enrolled, we are almost 30% to hitting our enrollment goal of 10 participants. We are prioritizing recruitment of IBD Active participants at this time, since flare samples are more time-sensitive than baseline samples.


Since June, we have enrolled 30 IBD Active patients and 2 Control patients. IBD Active participants who don’t flare during the course of the study will be re-classified as Controls, and Controls who do flare during the study will be re-classified as Active participants.



Who’s enrolled?


At ImYoo, we believe and invest in patient-centric research approaches that make representative patient participation possible. We’re proud to share that so far we’re seeing representative participation across race and ethnicity, gender (when adjusted for incidence), and are reaching patients in 19 states.


The above charts display our current enrollment numbers across ethnicity, gender, and geography. In 2022, the demographic distribution was reported approximately 3 times more prevalent in whites than non-Hispanic blacks. Our demographic distribution reflects 9 times more prevalence in whites. We also acknowledge that IBD may be under-diagnosed in minority populations, so we are especially focused on representing these communities. The gender distribution in 2022 was reported approximately 3 times more prevalent in females than males, which our numbers come close to. Finally, the geographic distribution is equally prevalent across all US states. We are currently in 19 of the 50 US states. (Hawaii is not depicted in the map, but we’re there, too!)


We’ve done a good job of keeping diversity in mind, but we can be better about enrolling more minorities and males. Please help us by sharing our study!


We’re also excited to announce that we are introducing new, additional compensation for participating in our IBD Flare Study. In addition to receiving your immune report at the end of the study, we will also provide monetary compensation for the time participants took to collect their samples! Patient scientists already enrolled in this study will be retroactively compensated.


The compensation will be $125 for 3 samples collected or $250 for 6 samples collected.


This compensation will be emailed to you via virtual gift card. (You can choose Amazon or Charityvest). After we’ve successfully processed your first 3 samples, we will email you a link to choose and receive your gift card. If you collect 3 more samples, we will email you another gift card after we have processed them.


Additional terms and conditions can be found in our direct communications with enrolled study participants.


That’s enough from us. Hear what our patient scientists have to say.



Snapshots of conversations with two different patient scientists in our IBD study. They were asked permission before we posted this article and we've kept their identities anonymous.


Thank you to our IBD community for your strength! We are especially inspired by our patient scientists who persevere through their flare-ups. Your enthusiasm for the research inspires our team every day and strengthens our community. Thank you!


-Emily







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