COVID-19 demanded accelerated innovation across a breadth of fields—and for one company in California, the pandemic made them think about how they could continue clinical testing remotely. Combining machine learning and at-home testing capabilities, Serimmune Inc. is seeking to help patients test for unique immune responses in their serum. Now, the team is one of 10 Phase 1 winners that have advanced to Phase 2 of the LymeX Diagnostics Prize, a prize competition to accelerate the development of Lyme disease diagnostics.

Through September 2023, the Phase 2 cohort is participating in a virtual accelerator designed to help them refine their concepts for detecting active Lyme disease infections in people. The goal of the multiphase LymeX Innovation Accelerator (LymeX) competition is to nurture the development of diagnostics toward Food and Drug Administration (FDA) review.

We spoke with Serimmune’s Chief Technology Officer John Shon and Vice President of Business Development Rocco Raduazo to understand how Serimmune’s test could recognize unique immune responses, distinguish between different infection stages, and expand accessibility for patients.

Antibody testing has been the foundation of Lyme disease diagnostics for over 25 years. Having studied Lyme disease and other tick-borne diseases for several years now, how is Serimmune utilizing antibody testing to develop an innovative new approach?
Shon: “We have a serology test where we can use a very small amount of fluid, and we look for everything—all the antibodies and what they’re recognizing in the blood. In the course of Lyme disease, you get infected and your body develops antibodies against the bacteria that causes Lyme, Borrelia burgdorferi, but the antibodies are looking at many, many other things.”

Raduazo: “And as we develop the assays of which peptides are associated with that antibody, we can then tell you whether you have had exposure to that infection.”

Shon: “What’s special about our approach is that when your body develops an immune response, that’s very specific to you. In the case of Lyme disease, just like COVID-19, some people get it and they may not even know it. Other people get it and they get a rash or not, and maybe the acute symptoms. And then some people maybe have nothing initially but then have late Lyme.

We actually published a paper that showed that we can find some potential antibody differences in folks that have late Lyme versus early Lyme. I think folks in oncology are familiar with something called precision medicine or precision oncology, where you’re treating your exact tumor type. For us, we can potentially distinguish between different subtypes of disease. It’s using sequencing technology in a way that really gives you high resolution and maybe subtypes of disease.”

Early diagnosis of Lyme disease is critical—but that means patients need to be able to access testing quickly and easily. How will you expand access to the diagnostics process?
Raduazo: “We’re working with an organization called Tasso, and it’s a little armband kit that you get with a lancet in a button. We send it to you in the mail. You have a red button, you push it, it draws 50–100 microliters of blood, and it drops a couple of drops of blood into a tube. You close it up and there’s an envelope there. You drop it in the mail to us and then you get your results two weeks later.”

Shon: “From an FDA perspective, we think there’s going to be a lot of value to having a home-based test or kit. It really decreases a barrier for people getting tested.”

Through a virtual accelerator program, Phase 2 of the LymeX Diagnostics Prize provides access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the teams progress toward FDA review. What has been most useful to your team?
Shon: “We have one technology, but having trained in medicine, coming up with solutions is not just about the technology. It’s about a shift in education and culture and operations and technology. What I’ve been really just amazed by is the different arrays of technology. What I’ve really appreciated is the ability to connect with leaders in the field.

Just to be part of a community that’s really trying to solve a serious problem—which again, I really think it needs a lot more resources than it’s getting, similarly to long COVID. It’s not about us as a company. This is a problem that needs to be tackled and it’s going to be multifactorial in solving it. And it’s better if there are multiple solutions.”

Given the multiple barriers to developing a test for active Lyme disease, a breakthrough in diagnostics could have huge implications for diagnostics innovation overall. Where could you envision your research going next?
Shon: “Our vision, really, is not just about Lyme. We’re working with multiple different groups now, looking at a broad array of conditions, because the immune response is important in almost every disease: cancer, autoimmune disease, infectious disease.

And increasingly I think what’s being recognized—it’s actually the history of medicine—infections or long-term infections lead to chronic problems like cancer, autoimmune disease, and neurodegenerative disease. There’s a huge amount of interest looking at things like the gut microbiome and Alzheimer’s disease, and it’s just a really, shockingly, poorly studied area.

Part of it is, I think, the immunologists haven’t had the tools that we have now, so we see ourselves providing foundational research insight for academics, and we have worked with institutions like Yale, Mayo Clinic, Stanford, and UCSF.”

The implications for research are clearly huge. The long-term goal, though, is of course the patient. If your test is successfully validated and approved for the market, how could your concept change how patients are diagnosed and treated? 
Shon: “While we’ve developed a test specifically that looks for antibodies against Lyme, we can also look for antibodies against any other organism, and even things like autoimmune disease and cancer.

But our long-term vision is really to see this—just like you might take your blood count—as a long-term monitoring thing. Instead of just getting one readout, we’re getting your whole repertoire of all your exposures and/or new exposures that otherwise go unrecognized.

I think most people would agree that multiple sclerosis is a result of a chronic Epstein-Barr virus infection, or that the infection precedes it, and likely with Type 1 diabetes, a lot of potential infections like Enterococcus. How that happens is not clear, but if we understand how it happens, we may get insight into how to actually treat that—and even better than treating it, preventing it.

We think that the immune system will know before either you as a patient or the physician will know that something is there. HIV and the hepatitis infections are all great examples of that, where chronic infection leads to long-term sequelae of fatigue, arthritis, cancer, autoimmune disease, you name it.”

Raduazo: “I see it as a subscription model where the consumer would pay once a year, twice a year, three times a year, then we’ll send you a kit in the mail, you send it back and we can give you a snapshot.”

Shon: “Unlike other diagnostic tests where you say it’s positive or negative, we keep this data and we learn from this data. As we grow, we’re just adding more and more panels, we’re learning more and more about the repertoire, and we get smarter and better. I’m sure you’ve heard of ChatGPT, but we are using machine learning. We will continue to use it and get better and better over time.”

Looking ahead: Expert judging panel to convene in October 2023

Following the accelerator, the cohort will submit concept papers that detail solution refinement, clinical and patient input, and a roadmap from lab to market. The competition judging panel—composed of experts across biology, clinical and technology translation, patient experience and advocacy, diagnostic science and technology, exponential innovation, and ethics—will evaluate eligible submissions according to official Phase 2 evaluation criteria. Based on the judges’ evaluations, the panel will recommend up to five Phase 2 winners of the LymeX Diagnostics Prize.

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