Danguole Altman, Cx Precision Medicine - Proteomics & ML for Biomarkers | LSI USA '24

Danguole Altman  0:03  
I'm Danguole Altman CEO of Cx Precision Medicine. So we have a big problem that is hitting us. And that is the number of patients with neurodegenerative diseases such as Alzheimer's and Parkinson's, which are all age related, are hitting the medical system, almost all those patients start their diagnostic journey with their primary care physician. However, the symptoms of early onset Alzheimer's or early Parkinson's are really non distinguishable from a lot of other conditions. So the primary care physician has to refer to a specialist for really a full diagnosis. There aren't a lot of specialists in areas, and people have to wait four months for an appointment, usually six to 12 months. So here's our solution. It's a blood based tests at the primary care level that can say, Are these symptoms, not Alzheimer's, or Parkinson's. And if you're positive then moves on to seeing a specialist. So this is the example from Alzheimer's, there are a lot of things that cause early memory issues that are listed on this chart, there's only one that's non reversible, and that is Alzheimer's disease. And that really needs to be diagnosed by a specialist. All of the other things are reversible and can be treated at the primary care physician level. So what are our blood tests does is give a binary result, it either says that you are ruled in and that means this is the patient that really needs to move on and see the specialist or you are ruled out which means primary care doctor go figure out what are the other things that are going on with this patient. So what that means is for patients, it means that it gives them a lot of peace of mind, the number one concern for people over 50 is Alzheimer's disease. So peace of mind, if they're ruled out, they're not ruled out, it's a path for a much faster diagnosis. for primary care physicians, there is no efficient biologically based tool that they can use. So that also not only results in a more accurate diagnosis, but it keeps a lot of the care at the primary care level. And for payers, it means a decrease costs from not having to do the specialty workup. So this is an example from neuro first memory the Alzheimer's test. So step one is the primary care physician. And steps. 234 are where the patients go after being at the primary care physician. If you can do our test at step one, you can avoid those costs from step through to step four, which is between $500 and $1,000 $11,000 of savings per patient. So this is a massive total addressable market. And actually, with very conservative estimates, it's about two to 4 billion in the US alone, probably double that internationally, there are assumptions, we've done a lot of work on what the price per test would be, and what supported by current reimbursement. So we're feeling pretty confident about that. And these assumptions assume that only 10% of people with existing symptoms, and 50% of those of new cases are targets for the test. I mentioned the savings from to the system of having the avoided costs of having the specialty work workup. But there's also savings from lowering the risk of people that really shouldn't be on some of these new drugs that are coming out getting put on those new drugs. It also means an earlier diagnosis and better outcomes for those patients that do end up having either Alzheimer's or Parkinson's. So there's been a lot of work in the news on these types of tests. So we look at the competitive landscape as the competitors falling in one of two buckets. The first bucket are what I call prognostic tests, and those are usually things that say you have an increased risk of Alzheimer's or Parkinson's and they're usually based on some type of genetic factor. Maybe there's some proteomics in there, too, that they're for non symptomatic people that are worried. The other category are really triage for advanced imaging. And those are really, usually amyloid tau based tests. They've usually been developed because a drug company developing a drug was looking for inclusion and exclusion criteria. And they are meant to be done after a cognitive assessment to patients that are generally at the specialists level, and they're symptomatic. We're the only ones that are really sitting there at the primary care level that says do you rule somebody in or do you rule somebody out? So what the technology is based on as I mentioned, it's a blood based test. We're measuring multiple 21 biomarkers. It's built on a very scalable platform Illumina X platform multiplex. And then those results feed into an algorithm. That algorithm has been trained on a massive 1000s of patients database of fully characterized patients that are diseased or not diseased. And that's what determines the test result. We have a robust pipeline, we're starting with neuro first memory. After that Parkinson's tests for people 50 And up that have movement disorders are concerned about Parkinson's. And then we've licensed some patents around different Alzheimer's subtypes and also have done published work on the Lewy body dementia. So all of this comes from it's been licensed from University of North Texas Health Science Center center. Brian, who is the scientific founder is the most funded person in blood based biomarkers in neurodegenerative diseases, I think in the world is either number one or number two in the United States. 250 million of non dilutive funding. Over the last 10 years, it's been used to build multiple studies build large, ethnically diverse bio repository and a large database. over decades, we have an exclusive license with the university to commercialize the work coming out of Dr. O'Brien slab we've licensed for patent families 18 patents have been issued. We've raised a little under $7 million dollars since 2020. My own background is healthcare services and life sciences. So I cut my teeth after McKinsey negotiating payer contracts in a large multi specialty clinic and then doing physician practice management role up that included building out ancillary services. And then I've spent the last bunch of years in the life science industry in pharma. The rest of the team has a terrific background in commercializing diagnostics and also running labs, as well as pharma and clinical trials. Advisory Board is heavy into both people that have payer experience and also diagnostic experience. We had a very busy 2023 We validated all this work in a Research Use Only lab inked a partnership with a large diagnostic company and are moving towards having everything validated in a CLIA lab, we spent time developing what the payer budget impact model is to build the ground for reimbursement and then started discussions with KOLs. This is our go to market plan. We're planning to launch neuro first memory as a lab develop tests by the end of this year, and then followed by sales. Pilots, both with concierge practices and with payers, while we're working on securing reimbursement from the others and also initiating discussions with the FDA, given the regulatory landscape unclear in in diagnostics, it's kind of rinse and repeat with neurodiverse, Parkinson's after that. And then we haven't really done much with pharma, but there's some opportunity there as well. So we're raising seven to 10 million in a Series A and what that's going to be used for, for Neuro first memory to gain Medicare reimbursement, and to pilot these commercial launches with select private payers and also with concierge practices where patients would be willing to pay on a cash basis for these for these tests. The cash I have in the bank right now is what's paying for the LD T validation. So I'm racing for the commercialization. for Parkinson's, we need to transfer that those tests to the CLIA lab and have those validated as a lab developed test. We also one of the tough things in this space is being able to get blood samples that are fully characterize. So we've identified and secured access to a good number of additional samples that do need to be analyzed and so some of the funding will go there to help make our algorithm even more accurate. Thank you very much. Glad to talk to anyone