Sepsis is a global health crisis; without prompt care, sepsis can lead to death. HelixBind Inc. has developed a rapid test to identify early infection in the blood, receiving Breakthrough Device Designation from the Food and Drug Administration (FDA) in 2020. Located in Massachusetts, a Lyme disease endemic area, the company began to consider whether their research could be applied to Lyme disease diagnostics. 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 FDA review.
We spoke with HelixBind Founder and CEO Alon Singer and Chief Business Officer David Steinmiller to understand how the team is applying learnings from sepsis research to Lyme disease diagnostics, considering test design and functionality, and looking ahead to the next steps for the company.
Today’s Lyme disease diagnostics rely on the presence of antibodies in the blood. How have you applied your research in sepsis diagnostics to hone in on a test for bacteria?
Steinmiller: “HelixBind has developed a whole suite of technologies on a platform for invasive infections, perhaps the most important being bloodstream infections associated with sepsis. There are aspects of Lyme disease that are similar. And the announcement of the LymeX Diagnostics Prize has helped us to put a little bit more focus on this project inside the company and dedicate some staff specifically to this project.
Borrelia burgdorferi, the spirochete [a spiral-shaped bacteria] that causes Lyme disease, is in your blood at extremely low levels. Existing tests cannot detect something at that low level. What makes our technology different is we can actually sample large enough volumes so that you can detect something at low concentration.
So just to give you an example, the spirochete may be in your blood at concentrations as low as a couple of cells in a milliliter or a teaspoon of blood. Most tests can’t test that much volume. Our technology can assay large volumes, many milliliters of blood, and therefore we can detect something as low as a couple cells per milliliter.”
Singer: “From a diagnostics perspective, it’s a sense of frustration that if you have that bullseye, we know you have Lyme—but what if you have other symptoms but you don’t have that kind of textbook bullseye?
We’re not looking for the human response, we’re looking for the bacteria. So in effect, we’re looking for something right after the tick bite has occurred, or several days after when you start to have symptoms. What we’re looking for is the bacteria there as opposed to waiting for the immune response to build, then detecting it there.
Now the added benefit of that is you can imagine a situation—and this is known to be true—that if you’ve had a tick bite before or you had Lyme disease before, it’s hard to know if the current tick bite is what caused a disease; you’re always going to have that background antibody level. So people who live in endemic regions are going to have background antibody levels or background levels that say they’re positive, whereas our test will specifically detect a current infection.”
As you’ve seen with sepsis, the ability to provide an early diagnosis is critical for treatment. How will providers be able to use this test?
Steinmiller: “With the diagnostics platform, we have a disposable cassette. And the way it works is you take a blood tube from a patient, snap it into the cassette, slide in the box, and press ‘go.’
We designed this instrument in consultation with a variety of thought leaders in microbiology and infectious diseases to fit into the workflow of any hospital. But to be easy enough to use so that minimal training is required. There are multiple assay steps in our assay, and it all takes place on that disposable cartridge. All the reagents are already onboard; the instrument just monitors the cartridge.
And crucially, the technology was designed to be very flexible to be used with a variety of tests. So whether it’s Lyme disease, whether it’s a larger tick-borne pathogen panel, whether it’s bloodstream infections associated with sepsis and on and on, the platform remains the same. It’s just the reagents that are onboard the cassette.”
The Phase 2 virtual accelerator provides teams with access to a range of resources, including mentors, webinars, and networking. What has been most helpful to your team as you refine your concept?
Steinmiller: “Number one is the access to experts in the field. Because as you know, we don’t know what’s really going on with Lyme. It’s really confusing and just understanding the disease is complicated. And then how to do any sort of clinical study with this patient population is exceedingly difficult. And so having access to experts is helpful to be able to bounce our ideas off them.
And it’s helpful to do that in conjunction with other companies. For example, at the end of a webinar, there’s a question section and we get to hear the questions that other [Phase 2 teams] have and then build on those questions. Someone may ask a question in a slightly different way than we would’ve thought of asking it, or someone may have brought up a new issue, or we may bring up an issue. So the number one thing is the access to the experts, but the second is being able to discuss these things in a forum of multiple interested parties.”
You only have four months left in Phase 2 of the LymeX Diagnostics Prize. Beyond the competition, what is HelixBind looking to do next?
Steinmiller: “We have a whole pipeline of tests. We have a diagnostic platform, a little device that’s going to go into hospitals. It can also go into doctor’s offices, but it’s really focused on hospitals to start. Our first test is for sepsis. We are doing clinical studies now for that test and we will continue to expand those studies. And we should start—later this year or early next year—our studies for FDA clearance for our first sepsis test. And then we’ve got a whole pipeline of tests for other bloodstream infections on that platform.
For Lyme, what is very important for the company is to get clinical data on where our tests will be most impactful in the course of the Lyme disease treatment here. Is it in the first three weeks after a tick bite? Is it perhaps later for a patient who suspects they had Lyme disease? That’s to be decided. So understanding clinically where this test is most impactful is an important thing for us.”
The goal of the LymeX Diagnostics Prize is to nurture the development of diagnostics toward FDA review. But beyond a validated test for active infection, what impact do you hope your work will have?
Steinmiller: “Let’s start out with Lyme disease. Number one, we think our test is going to help diagnose patients who don’t know they have Lyme. We’re going to identify these cases and that’s going to lead to treatment. It’s certainly going to improve the quality of life for those patients who are treated. So that’s the number one driving issue.
We’re going to develop a stronger understanding of Lyme disease in general. So we think that’s really important, secondary to basically improving patient health. That same thing is true for our diagnostic platform; it is really going to change the way invasive infections are thought of. For example, the way you identify the pathogen associated with a bloodstream infection is you culture it in a Petri dish or in a culture bottle. That takes a long time and sometimes it doesn’t work. There are lots of cases of bloodstream infections where it’s never clear whether the patient actually has an infection because you can’t culture. There are various reasons why a pathogen may not be culturable.
Our test is going to change the way you do that because we’re going to be able to tell you what the pathogen is within hours of patient presentation, and we’ll catch those cases that are currently being missed.
So again, the driver is we’re going to save lives, because sepsis kills a lot of people, but just as importantly, we’re going to suddenly understand the disease in ways that we don’t currently understand it. And there are plenty of other invasive infections—pneumonia, joint infections—where the technology is going to be useful as well.”
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.
To receive all Phase 2 updates, subscribe to the LymeX Diagnostics Prize newsletter and follow @Lyme_X on Twitter.