After 15 years working in molecular diagnostics, I know how far the science has come and who is doing what in this industry. And right now is an incredible time to be working in the IVD space because there is so much potential to do so much good.
In 2015, I wrote an article about the mobile health revolution for BioCoder. For better or worse, much of what I said then is still relevant now. We have solved some of the portability and cost challenges with point-of-care and point-of-need diagnostics, but not all of them. Biomeme is well-positioned to address those remaining challenges and this is why I am moving into a new role as Vice President of Next Generation Platforms.
Since Biomeme’s founding in 2012, we have kept our mission to develop diagnostics for consumer use top of mind. We are getting closer to that goal. I have learned a lot about how to build, and not to build, these types of devices.
Meet Biomeme's founders, Marc DeJohn, Max Perelman, and Jesse vanWestrienen
The next problem to solve is to develop a portable platform that is small, cheap, and capable of quantitatively testing for a large set of DNA/RNA targets using one minimally invasive sample. We want to lower costs and increase capacity so that consumers can access reliable and accurate health diagnostics without wasting time (or exposing others) at an urgent care facility or a doctor’s office.
I recently attended the Association for Diagnostics and Laboratory Medicine’s (ADLM) annual scientific meeting. I saw a lot of potential for developing an at-home DNA/RNA diagnostic platform that can test for a wide spectrum of human biomarkers, infectious diseases, non-infectious diseases, allergies, autoimmune issues like arthritis, and even cancer. There is no clear limit to what we can do with these RNA and DNA signatures. I’m most excited by Biomeme’s host response-based diagnostics and the opportunity to move it from the hospital or the doctor’s office to the home. We need to develop tools with more capacity and a broader choice of test assays or testing panels. Recently, a few groups have succeeded at reaching the at-home IVD market for a narrow choice of biomarkers. But no single platform can support all the options just mentioned. We think it's possible...
Read: Jesse vanWestrienen's notes on ADLM 2023 Annual Scientific Meeting
For example, you wake up with a fever. Instead of making an appointment and waiting to see a doctor, you can go to the kitchen and run a simple test from a nasal swab that can measure your host response to determine whether it is due to a bacterial or viral infection as well as whether it might be due to specific pathogen with clinical significance (e.g., SARS-CoV-2, Influenza A/B, RSV, etc.). 60-70% of clinical decisions are affected by lab test results, but this critical information is often unavailable to clinicians during telehealth visits (let alone at the point-of-care). This doesn’t exist today, but we are hard at work at Biomeme to develop a viable product for the home user.
In my new role, I will focus on early research and development (R&D), which is my real passion. I’ve had to wear many hats as a co-founder over the last eleven years. As we’ve grown and now begun to develop and deploy human diagnostic products there is a greater need to specialize engineering teams into early R&D, product development, manufacturing, quality, etc. I’m excited to work with an extremely talented team, many of whom I’ve worked with for years.
This next-generation platform will be the culmination of my learnings over the last 15 years of portable molecular diagnostics research. We want to develop a product the size of a toaster or smaller that is quantitative and can measure a large number of DNA/RNA pathogen targets or mRNA/protein biomarkers. If we can do that, we can offer both large syndromic pathogen panels (e.g., sexually transmitted infections, respiratory pathogens, antibiotic resistance markers) as well as host response-based diagnostic signatures. Such a platform would have an enormous impact on the consumer health market, delivering value and efficiency and improved patient outcomes at a massive scale.
Biomeme: 10 years in the making
We know consumer perception is important. Like a Keurig, SodaStream, or an electric toothbrush, this device would be there when needed, but not obtrusive. Over time, this device would evolve from a nice-to-have appliance, affordable to some, to a must-have appliance accessible to everyone. If we build a product that functions well for the consumer market, it will also be applicable to our current military and hospital settings.
What’s needed now to advance Biomeme’s mission is the ability to work at a strategic level and be even more forward-thinking. With an experienced team focused on platform innovation, we can use the lessons learned from the iterative evolution of our Franklin and Franklin ISP thermocyclers to chart the next stage of our work and tackle Biomeme’s core founding mission: Improving global health through easy-to-use, point-of-need, portable diagnostics. We want to empower the patient to take on more control over their health, and I aim to do exactly that.
Products currently under development and not approved/cleared by the FDA.