Early Answers, Better Outcomes: How Cx Precision Medicine Is Rethinking Alzheimer's Diagnosis From the Ground Up

[on-hold jingle] Welcome. My name is Unity Stoakes, co-founder at Startup Health. Today, we have a Moonshot update from one of the health transformers in our Alzheimer's Moonshot, Dangla Altman, who is the CEO of CX Precision Medicine. We're gonna be learning about the progress being made in diagnostics, in early diagnostics for Alzheimer's and dementia.

[upbeat music] Welcome. How are you today? Good. How are you, Unity?

I'm great. I've been really looking forward to this conversation because I think you guys have really been leading the way in terms of transforming diagnosis of neurodegenerative diseases, and it's just such an exciting time in history, I think, for where things are going. So I wanted to check in with you, have a, a full Moonshot update on, first of all, what's going on at CX Precision Medicine, and I know you've made tons of progress over the past year, and you have a lot of exciting things on the horizon as well.

So I thought we'd dig into all of that, if that's okay, and- Absolutely... uh, so maybe just to kick things off, remind everyone what your mission is as an organization and where you've started because you've got really an exciting early diagnosis for primary care physicians, which is a huge opportunity. Yeah. Thank you, Unity.

Yeah, uh, basically the diagnostic pathway for patients suffering from Alzheimer's, Parkinson's, neurodegenerative diseases is really broken overall. We all know there's a huge number of people, but it's also a very expensive journey and one that is a complicated diagnosis, and it takes so many years to access each point. In general, to the first visit from symptoms, it's six months to 12 months to even get a specialty referral. And there was actually a really interesting study that was shown last year that was one of these mega analyses.

It's three and a half years from when that patient first realizes they have symptoms and sees a physician to when they actually have a full diagnosis. So a lot of that is because patients start at their primary care physicians, and those primary care physicians really don't have the full set of tools that are really needed to be able to move those patients, really move them, uh, forward. There's no easy test. There's a lot of interesting things that are coming out, but they're hard to deploy in an environment that is very resource constrained, both in terms of the primary care physician's time, that of their staff.

So our mission has really been to use technology, AI plus blood, and provide easy-to-use tools for primary care physicians, not to diagnose the specific subtype and to do all those complicated needed things, but just to triage patients. So that has been our focus. We've spent the last year or so really working on our first test, which we call NeuroFirst Memory, which is for patients with symptoms, so it's not a screening test for non-symptomatic patients. It's really a tool for a primary care physician to take a patient that has possible symptoms and basically say, "Should they be moved on to a specialist or shouldn't they?"

So it's a very different kind of intended use than the amyloid tau tests that are really detecting amyloid tau pathology. What we're just trying to do, is this really linked from a very broad standpoint dementia that is likely caused by Alzheimer's disease? And we have a similar test for Parkinson's. So that's now moving along.

This is a rule out test right at the beginning. It's a rule out test, yeah. At primary care- Right... the first test that someone should take before you even waste three years trying to get into your specialty diagnosis.

Exactly, or figuring out if you have amyloid pathology or not, or is it tau only, or is it late, or is it all of those things which have to happen to be able to treat that patient. But it's really that preliminary test to say, "Hey, it's really a rule out. It's very unlikely these symptoms are caused by dem- Alzheimer's dementia." So if you can rule that out, then that lets the primary care physician say, "Okay, what are the other things that are going on with that patient that may be other conditions that at those early stages really look the same?"

'Cause the problem is, as you've been in this space a long time, at tho- at those early levels, the symptoms cannot really be distinguished. When, uh, you're talking MCI or early mild dementia, those symptoms can look like a lot of... can be caused by a lot of other things. It could be long COVID.

It could be menopause. Could be anxiety in patients. It could be they're not getting enough sleep, or they're having a vascular condition, or there's a metabolic condition. When they're starting to get more towards that moderate and severe, then everybody around them's starting to realize, boy, there's really a problem.

Mm-hmm. But you've missed that effectiveness window of intervention, and that's whether those are the new drugs that have been approved, whether that's drugs that are in the pipeline right now. They're all doing inclusion/exclusion criteria for people that are early. There's some great things coming, and I've learned so much being part of the startup community with people working on neurotech devices and various neuromodulation devices that can be effective.

They're also only effective early. And even when you look at lifestyle modifications, risk modifications, such as those as described in the POINTER study and in all of that great research that's coming out, those are also early. So once you hit moderate or severe, it's a problem. Mm-hmm.

Unfortunately, the primary care docs can't really-It's a lot easier sometimes to either say wait and see, or if you're waiting that three and a half years, you can miss that window and the disease is progressing. Yeah. And technology offers such a, tools that were not possible before, to be able to analyze these big databases and really figure out how to develop tools. In our case, our underlying research comes from one of the largest multi-ethnic, not just study, but multiple studies that were done at the University of North Texas and are ongoing.

So there's thousands and thousands of characterized patient samples, and that data can really, has been used to build our products and our pipeline. And our focus has been on these primary care products, first on memory, which is more sort of Alzheimer's adjacent. Parkinson's we're starting to work on, but there's some other things in there too. So I wanna make sure, I wanna double tap on a few things here that I think are very profound.

First of all, just the early diagnosis or ruling out rather, is so critical because if you can save time, then it- Yeah... opens up other potential trials or things that might be available to you, whereas if you wasted three years, they, those might not be options anymore. Yeah, absolutely. And the other thing you have to th- and think about is for the people who are ruled out, what peace of mind there is.

Because if you're a patient and you're worried about yourself, you have these symptoms, you're worried, well, what if I, uh, what if it is Alzheimer's and there's no return? So if you aren't ruled out, then that allows that accelerated path and hopefully cutting that three and a half years down and getting help at a time when treatments can be effective. But if you are ruled out, that also gives a lot of peace of mind, and then a much more accurate diagnosis in terms of, okay, you know what, it's really not your b- worst fear, good news, but here's what else is going on.

Right. Let's try to affect this. Maybe they have sleep apnea. Maybe they have hearing issues or something that have not been caught in a very short preliminary visit, but then allows a deeper dive into what are the things that are causing the memory issues.

And I imagine there's also a significant cost savings if pe- not everyone is taking- Yeah... those more expensive tests, and many of those people may not even have needed those tests down the line. Yes. Our estimate is about 80% of people will be ruled out, so these are people that are 60 and up, uh, that have some memory or complaints of...

It's subjective cognitive impairment. It's not there are people that are complaining, feel that something is off, and roughly about 80% of them are likely to be, or 75, 80%, but a large majority should be ruled out. You're absolutely right. There's really substantial cost savings from that for a payer, because if you can keep people at their primary care physician, pretty much all of those other things can be evaluated in primary care at a much smaller cost, where once they are into that other sort of specialty referral pipeline, then you're talking about specialty in the waits, and MRIs, and full neuropsychological cognitive testing, and of course the amyloid blood tests that are a small portion of that.

But in many cases they'll need a PET amyloid as well. So there's a full complex of diagnoses that end up happening, and if they've got a more unusual pathology and they don't have amyloid and they have tau, it's, there's just a lot to consider. And so there, it's just resource constraints. So yeah, it can basically save money and increase people's health.

Here's a... This might be, uh, the wrong question, but is there a world where everyone should take this test, or it's only, you mentioned specifically it's for people who are presenting. Now a lot of people are trying to increase their lifespan, they're trying to diagnose early. If someone wanted to pay, would there be any reason to take this significantly early, even if they weren't presenting, or is that just, it doesn't work that way?

It could work that way. However, we are really working on making this test accessible to everyone, and accessible means that frankly, we need insurance to pay for that test to be accessible. I see. And insurance will not pay for screening tests in general, for, especially Medicare, in particular Medicare, because when Medicare was set up in the mid-'60s, they said, "Okay, we're gonna only pay for the things we know about that are screening tests," so they'll pay for mammography, they'll pay for Pap smears, they'll pay for a certain list of things.

They don't pay for other screening tests. And so while... And I think that's been one of the challenges, right, for G- for the Galleri, GRAIL's Galleri test, which is a liquid biopsy test. They've really struggled with reimbursement from Medicare because it's a general screening test.

If it w- so from a commercial practical standpoint, we really have designed it and moving that path to make it a triage test and not a screening test. But if you ask me as an individual if this test is available to me and I'm gonna see my, a concierge physician- Right... will this accurately detect things, and let's take the insurance piece off the table, someone's able to pay, absolutely, and you're age appropriate, why wouldn't you go ahead and take that test? Yeah, I know a lot of people are through, like, function health and these places- Yeah...

they're taking tests that normally, and they're paying out of pocket, and it's, as the costs come down in particular and these things- Right... become more affordable, I could see a world where, boy, if it actually can work for everyone, why wouldn't everyone take this test many years early? No, I agree, and I can see that if you, even if you track GRAIL and, and the Galleri test, and clearly GRAIL has had a lot of money they've put in towards telling people about the test and everything else, but nonetheless, they launched as a lab developed test in mid-2021.

They are not FDA approved. They've launched as a lab developed test, which is how we're launching. It's a very common pathway. Medicare has not paid-And still from mid 2021 to full year 2024, they had 100 million in revenue.

For 2025, they had 150 million in revenue. That is only from direct patient pay, and that's for a $1,000 test. So clearly they're showing that there are enough people that wanna be able to, to find the information out. One of my, uh, husband's friends who was diagnosed with a re- pretty rare form of cancer, and luckily now has survived that, but he happened to have taken the Grail test, Galleri test.

He paid $1,000 for it. The results came in, I don't know, a couple of weeks after a lot of money and a workup at MD Anderson to say what kind of cancer he had, and that test, the Galleri test, was right on. [laughs] And he said if that had been paid for in insurance, it really would've helped. It took a while to get the results and the timing of it.

So I think that in the future, having screening tests, being able to use all that data, that's the genetic data, proteomic data, to help patients be able to manage their care is frankly, I think, the only way, true precision medicine, that we're gonna get the costs in the system down. Yeah. And I think harnessing the availability of technology to be able to do that, it - that's why I think mostly I agreed with the vision that we talked about at, uh, during the JP Morgan event- Yeah...

with some caveat. And at scale even, the cost can come down significantly more, and- Yes... it just seems like this is the trend and we're starting to see. And I, I love your vision for access through all insurance, and if we can have direct pay and everyone basically gets access- Everyone...

and the cost comes down. And the cost comes down because one of the things I'll say for how Dr. O'Brien, how Sid O'Brien, who's the sort of scientific founder, built this, ours is built on a very scalable platform in that now I need the volume to be able to run it at scale, to your point, on getting those costs down. So we don't have that in the beginning.

But at scale, we can literally run thousands of tests in a week. It's not one of these tests that you need one test at a time and someone pipetting. It's a multiplex immunoassay, and it can really be automated and run at scale. So yes, you can get the cost down over time.

Not right now, but absolutely. Yeah. I just - I love the progress you're making, and one of the other things I wanted to get an update on from you is we've been talking about your NeuroFirst memory solution. Yeah.

I know you more broadly have, uh, an amazing pipeline of innovation. I, I don't know if - what you can share- Yeah... but there's important things that I know you're working on. Yeah.

We're starting to really move NeuroFirst Parkinson's along, so also very similar to Alzheimer's. Ages are different, but the symptoms are different, but there's so many people that have essential tremors or they have other gait and motor issues that in those early times can - you can't say is it Parkinson's or is it some other things that are not Parkinson's? And it's the same problem where primary care, there's not a way to tell. People wait for a long time to get a workup.

It's also a very long time for a diagnosis. So we have started to really advance work on a NeuroFirst Parkinson's test, and have made some progress on that in the past year. So that's very exciting. And then beyond that, part of the work that we have licensed from Dr.

O'Brien's work is on, in, in the industry they almost call it a reflex test, but it's really tests around subtypes of Alzheimer's. And right now there's Alzheimer's, it historically had been defined by symptoms, but I think as we move forward, the field is finding more and more that same name has disguised many other subpathologies underneath that. And so while we're not in the direct rule-in portion, we have had success, and Dr. O'Brien's had success, in taking blood samples f- from failed drug trials and then looking at subtypes that are more neuroinflammatory or metabolic or other types of conditions.

So we have - that's the next precision medicine for us is really that next frontier in that diagnostic journey. So we're not there yet, but we're starting to think further ahead of how we can use the information we've gathered to keep moving forward. So it's exciting. We're - It is exciting, and we're at this, I think, really historic moment, if you will, in history, the age of super intelligence.

What's your kinda macro view in terms of the progress being made, the opportunity before us? You're on the front lines. You're on the frontier. You've been - This - There's a lot of research that's gone into everything you're describing.

Yeah. Where are we going? Where - what's, what's happening? I, I think both the challenge and the opportunity is on the intersectionality of all of these pieces coming together that have historically been verticals.

So the verticals have been, okay, on the investment side, we are healthcare IT, health tech investors. And there's another vertical. I know we're life sciences and biotech, and there's another vertical of we are healthcare services, and we provide services. And those are, those are as they've been for a long time.

But I think as you're looking forward to the future, the true innovation will be on connecting those different spheres and using the information that's available to really drive meaningful outcomes. 'Cause at the end of the day, it has to be about-The patient and the outcome, and the outcome for society. And that's, I think, it's starting to happen, and people are starting to bridge that. We're not there yet.

So far, the use cases for AI, it- have been large in healthcare, but they've been very focused on either that back-end administrative support- Yeah... getting pl- claims out, getting information out, decreasing the operating expenses. It's played in life sciences a bit, but on much more drug discovery. How do these proteins fold?

Can we do things on that? Not so much really into clinical trials. And so- Do you see that, that accelerating? Agree, most of what we've seen has been on the administrative cost savings- Yeah...

which makes sense, but do you see the next two, three years, that dynamic changing, where there's much more discovery happening with AI? I think so. I don't know if it's discovery. I think that where the opportunity is really using AI as a tool, not just as an agent, but using that information to really be able to inform decisions and move that forward.

That has not happened yet. There are some folks that are looking at tech plus bio together a bit, and they're talking about it, but I haven't seen any use cases yet. You have clinical decision support tools- Right... and usually those are being developed as information of primary care.

But there's been a line of, we don't know if we wanna cross over to life sciences, 'cause that's a different regulatory sphere. That's a different reimbursement sphere. But I do think that those bridges, those are gonna break down. I think that as people are starting to look at really where we can go in the future, 'cause at the end of the day, it's information, right?

And it's faster processing of information. Right. And how can we use that to provide a better outcome? So I think in the future, that's where it's eventually going.

I hope it's going that way, because I think that's an answer. To me, it's inevitable, and- Yeah... it's writ large, I think one of the best use cases for all AI is what we're talking about right now- Yeah... and solving these real impactful challenges.

And I think we can do it, and I'm just so excited about the work that you're focusing on the early side because if we, you mention outcomes, if we can just identify and diagnose or rule out early, then imagine how much time we can save to then- Yeah... have better outcomes. Yep. Uh, last question.

Where are you in the life cycle? Who should be reaching out to you? Yeah. What types of organizations or investors?

And if I'm an everyday patient, can I, when will I be able to go to my pri- primary care and kinda ask for NeuroFirst Memory? Yeah. So we are planning to launch NeuroFirst Memory as a lab-developed test but on a limited geographic basis first. Certainly, as a patient, it will depend where you live because we really wanna make sure we can scale from a reasonable sort of learn, beta test it, make sure everything is, is working.

So the beta tested version for a small group of people should be by the end of this year, maybe beginning of next, but in relatively short term, less than 12 months for... But we are sta- starting to plan for that much larger kind of rollout vision of the entire group. So from an investor standpoint, we're just kicking off a large Series A to be able to really accelerate and to do that. Exciting.

More of that to come. So that will be really... I think there's so much opportunity, and the time to really act is now. Every moment counts.

Investors out there, if you're listening, please reach out to Dengue Aultman. This is important work. We are grateful that you're part of the Alzheimer's Moonshot and Alzheimer's Moonshot community. It's just tremendous to see the work that you and your team are doing, the progress being made.

It's a novel area of focus, and it's really important to diagnose early or rule out early. Thank you for everything. And thank you so much for starting StartUp Health and putting so much of yourself in all of these different communities, and it's really, I think it's really helping accelerate change in the healthcare overall this country. So thank you, Unity.

Thank you. All right. All right. We'll see you soon.

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