Maha Sallam, PhD, President of VuEssence Inc talks about a blood test that could potentially diagnose stroke faster.
Interview conducted by Ivanhoe Broadcast News in June 2019.
Can you tell us a little bit about the test and how significant this is?
SALLAM: Yes. We are working on developing a test that is effectively a blood test for detecting stroke. We feel like there is a need for that. Stroke is a very serious disease. It affects many people every year, and it leaves a lot of disability and causes death in its wake. We feel that we could offer additional information about the underlying biology that the body’s going through when a patient is experiencing a stroke. The work that we’ve been doing is focused on turning that information into a test that can be used in the clinic.
And who would be a candidate for the test?
SALLAM: Anybody who is experiencing symptoms of stroke is a candidate. We’re targeting patients who show acute signs of stroke initially. Our test is based on doing an analysis of the blood and measuring the biology that’s happening within the body at that time. There is potential for extending the analysis beyond the acute stage to where we analyze the patients as they go through the treatment process and maybe to determine the reason behind the stroke and how to best manage the patient later on.
What’s done now with patients to decide if they’re having a stroke?
SALLAM: Right now it’s based on the clinical assessment of the patient as well as imaging. We can do CT imaging and MRI imaging of the brain as part of the stroke workup available right now, but it’s always under pressure to be done very, very quickly, as soon as the patient shows up with the stroke symptoms so that they can administer treatment very quickly. The acute nature of the disease makes it important to be able to do everything we can to find out everything we can about the patient in a very short amount of time at the beginning, as soon as they show symptoms.
So this blood test could be done quickly. You get the results.
SALLAM: That is our goal. This test is under development right now. We are working really hard to reduce the amount of time it takes to measure the gene expression in the blood, which is what we base our test on. Doing that is not simple. It is a long process, typically. But we have been successful in reducing the time it takes to be able to measure the expression value for certain genes in the blood with the work that we’ve been doing.
Is there a ballpark of how much time?
SALLAM: Our goal is to get the system to process the patient within 15 minutes. We think we can do that and we will work toward reducing that time as well. That’s really at the heart of what we do.
So once you get the results, then that’s how you dictate how you’re going to treat the patient?
SALLAM: It will contribute to the to the doctor’s decision-making process. So this is a window into what’s happening within the body and the underlying biology that they don’t have access to at this time. We’re hoping that between imaging, clinical assessment and the information about gene expression changes, we can give physicians more complete insights as to how to best treat that patient, and if the patient is actually experiencing a stroke or something that looks like a stroke. Our goal is not to replace imaging, but to add to the insights that the physician has to be able to treat the patient in the best way possible.
So it seems like time matters the most.
SALLAM: Time matters a lot. Accuracy also matters a lot. It’s a complex situation as you might imagine. There are thousands of genes that are being expressed in the blood at any one moment in time. Comparing the thousands of genes and figuring out which genes are actually significant and which ones are specific to stroke and not just for a common symptom or some other disease is also important. So the accuracy of the system, making sure that it is specific to stroke, matters. And also once we have that down, how quickly the test works is obviously critical in the acute stage.
So rewind back to when you first decided to develop this. What were you thinking? What were you hoping?
SALLAM: So I’m the founder of this company. This is my second startup. And the previous company that I started a long while ago was focused on mammography and image analysis for mammograms. My background is in engineering, so a little bit of a different area than blood analysis and biology. I had the bug to start another startup. That’s the kind of process I enjoyed the most and I love applying new technology to solve medical problems. In investigating areas that I could focus on, stroke came up as a really serious disease, but there was not enough innovation in my view that was going into dealing with the disease. So I targeted stroke and in the process of doing my due diligence and investigations, I uncovered some studies that were done at the National Institutes of Health where they had published preliminary results showing that gene expression does change in the blood when a patient is having a stroke. I was completely fascinated by the work and intrigued by the idea and I started looking into it, and that was the impetus for moving forward. We feel it will be worthwhile to pursue.
How significant do you think this is? It would be in the medical breakthrough category.
SALLAM: I think if we’re as successful as we hope we can be, and we’re seeing a lot of preliminary results indicating that we will be able to develop something that’s accurate enough and fast enough, I think it could be a game changer. At a minimum, it’s going to improve the tools that are available out there for the physicians as they diagnose stroke. Our hope is that as we do more research in collaboration with our clinical partners and specifically with USF Health, that we can actually get to a point where we can move beyond the acute stage and offer additional insight that tell the physician what’s really behind the clinical symptoms that they’re seeing in the patient.
So right now it’s in the clinical trial stage?
SALLAM: We’re preclinical trials. I would say it’s late discovery at this point, so we are still optimizing and finalizing the sets of genes and information that we’re going to incorporate into the device and also working on speeding it up. It’s still not close to clinical trials or immediate, but we’re pretty advanced in the discovery phase.
So it could be a while before doctors can use this in their office?
SALLAM: It could be on the order of just a handful of years, not much more than that because it’s a diagnostic device. It’s a little bit different than an implantable or a drug that takes a lot longer.
When you said the goal is within 15 minutes of showing signs, like clinical signs of stroke, are you talking about from the time they get to the hospital? Or is this something you could foresee in the EMS like on the truck?
SALLAM: That’s our goal. So typically molecular diagnostic blood tests are done in a lab and need a long time. Our goal is to integrate everything into a self-contained device that is able to process samples from blood to results. To the extent that the device can be robust enough to place on an EMS vehicle, it’s definitely an option. It’s something that’s always in the back of our minds. But our target right now is to get the test done in a hospital setting as soon as possible after the patient is able to contribute the blood sample.
What expertise does Dr. Burgin bring?
SALLAM: Oh tremendous, tremendous, tremendous. I mean, as I said, I’m an engineer by background. My team is biologists and technical engineers. We wouldn’t be able to develop a device that’s useful to a clinician without having a clinician who is really involved on a daily basis with our work. So the clinical expertise that he and his team bring into the process and where their points of pain are – what would be most helpful from a clinician’s perspective to make better decisions for the patient – is absolutely a critical piece of information that we need to have.
We must prove with clinical testing and show that the physician using the device does better, or maybe the patient does better with the device than without. This would be determined by the clinical studies. But for now there is every indication that the more information you know about the patient and what they’re really going through – the better the diagnosis, and the better your treatment plan would be for that patient.
And the treatment is done right there? Is it medicine treatment? What could be done differently?
SALLAM: So for stroke I’ll let Dr. Burgin talk about the clinical treatment. He’s in a better position to explain that obviously. But typically it could be medications given to the patients to dissolve a blood clot, if that’s what’s causing the stroke. There are multiple causes behind it and It can be a complex disease. Sometimes surgical intervention is appropriate for certain patients. So it takes a stroke team and a very experienced neurologist to be able to make the right judgment for the patient and to decide on the course of treatment.
So having a blood test would be one more tool.
SALLAM: Exactly. Exactly. And it’s a different type of input because now they have imaging. They see the physical structure of the brain through imaging along with functional information about the blood flow and everything, and they see the patient and the clinical symptoms, but they don’t really know how the biology in the body’s changing for that patient necessarily at that time. So we’re hoping is to add that information for them to use.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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