Hello, everyone, and welcome to our Aspira Women's Health Fall 2024 R&D Investor Day. I'm Nicole Sandford, CEO of Aspira Women's Health. I'm going to be your host today, joined by a number of other folks that I'll introduce in just a moment. But I do want to thank you for being with us today. We have a lot of exciting updates to provide, and we're going to jump right into it. So we'll go to the next slide. Quick reminder that we will be covering forward-looking information. Ask that you take the time to go read Form 10-K and other public disclosures to provide the context needed. Okay, so today's discussion, we're going to start with some introductions and an overview of the award summary from ARPA-H. Exciting news that we're going to share a lot of additional context.
We're going to also give you an update on our product development program, including our ovarian cancer pipeline and our endometriosis pipeline. We'll wrap up with a brief discussion of the market opportunity, and then we'll open up for Q&A. So with that, let me quickly introduce our wonderful panelists today. Dr. Richard Gersch, he serves as a senior clinical advisor for Aspira Women's Health. This is his first program with the company. Welcome to the company, and thank you for joining us. He earned his medical degree from SUNY Downstate Health Sciences University in Brooklyn, New York, completed his OB-GYN residency at Thomas Jefferson University Hospital, where he was chief resident. Dr. Gersch has 32 years' experience as an OB-GYN and extensive industry experience, including clinical and medical affairs across both pharmaceuticals and medical devices at top corporations such as Organon and Merck. Dr.
Kevin Elias serves as the Lilly and Seth Harris Endowed Chair for Ovarian Cancer in the Division of Gynecologic Oncology at the Taussig Cancer Center at Cleveland Clinic. Dr. Elias' research focuses on the pathogenesis, early detection, and novel therapeutic strategies related to gynecologic cancer. He is on the editorial board of Gynecologic Oncology and has authored more than 150 peer-reviewed articles. Dr. Elias continues as an adjunct professor at Dana-Farber Cancer Institute. Dr. Elias received his medical degree from Vanderbilt University School of Medicine. He completed an internship and residency in obstetrics and gynecology at Brigham and Women's Hospital, Massachusetts General Hospital, followed by fellowships in anesthesia, critical care medicine, and gynecologic oncology at Brigham and Women's Hospital. Dr. Elias went on to complete a postdoctoral degree in chemical engineering at Massachusetts Institute of Technology. Dr.
Sandra Milligan is a C-suite pharmaceutical executive with a unique background, diverse professional experience, and leadership, with over 20 years of experience in large companies, and now serves as our President at Aspira Women's Health. Thank you all so much for joining us. So let's talk a little bit. For those of you that are new to Aspira, I know we have a lot of our long-term shareholders joining the call today. Thanks, as always, for joining and for your input and your interest in the company. But we do have a number of folks who are new and don't have the full background. So just a quick overview of who we are and where we are as a company. We are a revenue-generating commercial diagnostic company.
Our current commercial products include an aid to assist in the detection of ovarian cancer, and we're working on, as you'll hear a lot more about today in our pipeline, adding endometriosis to our commercial platform. We've had year-over-year revenue growth and volume growth since 2020. We have exciting news of a $10 million non-dilutive funding from ARPA-H, the Sprint for Women's Health, which will be funded over the next two years. Our innovative products, which you'll hear a lot about today, include an extension of our ovarian cancer portfolio, as well as adding endometriosis blood tests to our portfolio as well, which we believe will ultimately lead to a $1 billion revenue pipeline opportunity. We are really proud of the progress we've made, especially as a relatively small company around market access and reimbursement.
Our existing portfolio is all reimbursed under Medicare at $897 per test, and we have a number of commercial and state Medicaid plan reimbursements as well, and I'm especially proud of the executive team that we have assembled here at Aspira, including Dr. Milligan, and also later on in Q&A, we'll be joined by Dr. Todd Pappas, who is our Vice President of Research and Development. Next slide, please. I know the big news is the ARPA-H award, so let's talk about that a little bit and provide some more information. This was a historic investment in women's health. Nothing like this has ever happened before. I couldn't be prouder to represent women's health and the need for better diagnostics. This was announced last year by the Biden administration.
Last week, there was an announcement of the program, which actually was larger than the original announcement of $100 million. So $110 million was allocated by ARPA-H in the Sprint for Women's Health to accelerate new discoveries and innovation. It was a great feeling to see the very first bullet under the company's receiving awards was Aspira and our endometriosis test. And it was announced at the health conference last week in Las Vegas as well by First Lady Dr. Jill Biden. Next slide, please. So this was, to say the least, a robust and highly competitive process. I want to acknowledge Dr. Milligan for her leadership in our submission. We actually had several submissions. Each company was only eligible to receive one grant. That's the one we're going to talk about here. But I can tell you it was a company-wide, all-hands-on-deck process to put together our submissions.
Certainly, Dr. Milligan's leadership was the deciding factor, in my view. There were 1,700 submissions going back to April, 45 states, 34 countries, a lot of different folks bringing different ideas to the table. Ultimately, 59 organizations were progressed to a VC-like pitch phase. That was over the summer. Dr. Milligan and Dr. Pappas represented the company, went and presented our idea in more detail, and knocked it out of the park by all accounts. That actually led us to go to the next phase, which was the negotiation phase, where we worked collaboratively with ARPA-H and the Investor Catalyst Hub to lay out the milestones and objectives for the project and to create a path forward. We learned several weeks ago that we were selected as a finalist, and it's been a whirlwind ever since.
There's quite a bit of benefit to the program and a number of submissions that are required, really strong discipline, which is something that we really welcome here as we move forward. These are the areas that ARPA-H considered for women's health. So gynecologic health was, of course, a primary focus, but not the only focus. They were also interested in looking at projects that impacted women exclusively or differently. So neurological conditions, obstetrics, cancer, pain management, menopause, and cardiovascular. So we weren't just competing with 1,700 submissions in gynecology. We were, in fact, competing with a very, very wide range of research projects and ideas, and ultimately were successful.
We believe that we were successful specifically because ARPA-H was looking for in the Launchpad category, which I'll mention, and just I'll talk a little bit more in a minute about the difference between the Spark ideas, which were eligible for up to $3 million, and the Launchpad ideas, which were eligible for up to $10 million. We were selected for a Launchpad, and I'll talk a little more about that in a minute. But we believe the differentiating factor was our ability to our demonstrated experience and ability and the infrastructure in place to take an idea from the discovery phase all the way through commercialization, drive adoption, drive reimbursement. Having that experience with the ovarian cancer portfolio truly distinguished us from many, many of the other submissions, and I believe helped us to secure the largest Launchpad award of any awardee. Next slide, please.
So the difference between a Spark idea and a Launchpad, as I mentioned, Spark ideas are earlier stage. They basically are kind of what they sound like. It's a spark of an idea, a lot of work left to do to prove the concept, to create the path forward for the product, and certainly no expectation that there is a capability on the commercial side. That's not to say that these are not commercializable ideas. They absolutely were. And if you read anything that has been published by ARPA-H about the program, one thing that's clear is this is not just about funding science projects. This is about funding projects that will ultimately lead to a meaningful improvement in women's health and will do so in a relatively short period of time, which is exciting for us.
Launchpad, on the other hand, are ideas that are far enough along in the process that they could be launched and brought to market and brought to women in relatively short order, in our case, in the span of the two years of our funding, up to $10 million, which is, in fact, what we received for the award. But again, to be in the Launchpad category is a real validation of what we've built here. Over the last two years, I've talked over and over again about operational excellence and the investments that we have made in our infrastructure on the commercial side. Our lab has always been world-class. We've never taken our eye off the ball there. Having a CLIA lab that's been running a commercial product for many years, certainly a differentiator for our proposal.
So we were excited about the award and would have been excited no matter what. But clearly, to be in the Launchpad category, we had to demonstrate a capability that distinguished us from an early-stage idea. So taking that all into account, it is truly a milestone moment for the company. Next slide, please. Well, of course, the money's wonderful, and we are thrilled to have it. But it's far from the only benefit that we will be realizing as a Launchpad program participant. As I said earlier, the recognition is that women's health products and solutions take way too long to complete. They suffer from a lack of research dollars and capital. And when putting this program together, ARPA-H really wanted to address all of the factors that lead to those things being true.
So again, they've looked at what does it take to be successful in achieving what they're looking to achieve, which is a commercial program adopted by physicians, adopted by payers in a reasonably short time. Yes, it's capital, but it's also mentorship. And that includes having a program manager who is an incredible experienced resource to us, who can help us not only to identify risks to our success and execution risks that we need to manage, but help to fill those gaps. Incredibly important. Mentorship with the other program awardees. When we participated in the first kickoff, I'm sure I speak for Dr. Milligan and myself when I say that we were absolutely blown away by the other projects that are in the Launchpad program. We know we can learn a lot from each other, and we're excited to do that.
That also goes to the last piece around the network. I'll touch on that a little more. Accelerator, they have put together robust programs around each stage of development, each stage of the program, to make sure that we have what we need. There'll be a number of virtual and in-person workshops where we can workshop, for lack of a better word, challenges, look for opportunities to collaborate and work through those execution risks. And of course, the network. So we have already identified individuals who have expertise at every single stage of development, from the scientific discovery through the commercialization and everything in between, people with experience and relationships with regulators that are going to be critical for us to meet this very aggressive launch timeline through payer community, everything in between.
So as you can see, again, the capital is absolutely critical, but it's only one piece of the puzzle when you understand how truly revolutionary this is for the company's future and our future success, and how all of these things that we will be able to access will also help us with both our existing commercial portfolio and our ovarian cancer portfolio expansion, which we're going to touch on in a little bit as well. You can go to the next slide. So this is coming soon, but you can see all the different areas of support that we will be able to access. I should have mentioned these slides that have ARPA-H on the bottom. These were the slides that were presented to us as part of our launch last week. They gave me permission to share these with you as well.
ARPA-H did a press conference last week that I encourage you all to go listen to, and you'll hear a lot more, but as you can see, they've thought of everything, and we're going to have in the six areas: manufacturing, clinical design, IV&V, regulatory, and reimbursement. Those will be areas where we can access resources, which is people, network, you name it, so all of this is sort of being built real-time. They are moving at a pace that would make anyone proud. The government isn't exactly known for moving quickly, but I can tell you in this case, they are moving very quickly and leveraging everything they can from successful programs with other parts of the government, especially the Department of Defense, but also successful venture capital programs and processes.
So that translates into, you can go to the next slide, please. Our project, which is called Cracking the Code, a blood test for the diagnosis of endometriosis with multivariate AI analytics, again, leveraging everything we've ever succeeded at as a company in the past, all came together and culminated in Cracking the Code. This is what the funding looks like. Each milestone has robust deliverables that were very clearly negotiated with the Investor Hub, with ARPA-H as part of the contracting process. So we know exactly what we need to do at each step of the way. Knowing is wonderful, but there is a lot of work to do. So Dr. Milligan's team is looking to add folks to our R&D program as soon as possible. You can see there's a number of critical threads that run through.
One of the most important is that at every step of the way, we are looking for the solution that will lead to the most commercializable, adoptable test. We've asked Michelle Snyder, who previously served as our SVP of Commercial Operations and Strategy, to step into a newly created role to be the voice of the product, to be the voice of the end user, which is the physicians and the patients who will ultimately be ordering the test from the beginning through the end. She'll be supported by a team that makes sure that we are meeting every one of those deliverables and those timelines and makes sure that we're bringing all those resources to the table.
We believe that even though I know all of you would probably love for me to put dates up here next to these, I'm not going to do that because this is still science. Some of these things may go faster. Some of them may take a little bit more time. But the goal is within 24 months to have received the full $10 million, to have launched a test in some form, and to be well on our path to making it the standard of care across both the payer and the provider world. There'll be more to do after the 24th month, I promise you that. But we will be in a wonderful place of jumping-off point. We will fund those activities to start, and then these will be funds that come back to us.
So our initial project launch milestones, we're working on the submission related to those as we speak. We expect to be able to file everything we need to file for that milestone in the fourth quarter, which, of course, we are in at this point, and would receive the funding within a reasonable amount of time after that. A key to think about is we do need to fund those activities in advance. So as we receive the $2 million, we will use that to fund the next stage, R&D scale to meet operational needs. You can see that we're also, and this is very exciting, we will receive funding to build our molecular lab. So that going forward, I think most of the existing shareholders are familiar that we've been working with a wonderful third-party partner for a number of our development and research and development program needs.
Going forward, as we look to add tests to our portfolio, we will have the capability to do that in-house in a lab that will be part of our CLIA lab, and it will allow us to also launch a commercial test in the exact lab that we were able to do the final development. It's very exciting, and we're working on that as we speak. So they're not exactly linear. Some of these things are happening now, but won't really be part of milestone one. They'll be part of milestone four or five. So as we move forward, we'll do everything we can to keep our investors informed about progress. But the key to understand here is by the end of the 24th month, it is our intention to have a test that is in the market commercially and well on its way to becoming a successful commercial product.
Next slide, please. So with that context, and again, wanted to make sure I provided that because that is certainly something that I know a lot of you are interested in learning more about. A few key takeaways. Dr. Milligan will lead our execution. The whole company is going to stand behind her, give her everything that she needs to be successful. We will keep you informed as we move through those milestones. And now with that context, I'm going to ask Dr. Milligan to take us through an overview of our products. We're going to start with ovarian cancer. There's a number of things that have happened since the last time we had an R&D Investor Day that we want to be sure you have the full benefit of hearing those things firsthand. Sandy's going to talk us through some of those.
And then she'll take us through with Dr. Gersch and Dr. Elias as well. So Sandy, I'm handing over to you.
Good day, everyone. I'm going to start out with a brief product development overview just to refresh the audience the steps that we take and the different components as we put them together for our powerful diagnostics. Next slide. Our mission is to radically improve the health outcomes for women throughout the development and commercialization of novel gynecological disease diagnostic solutions. Our AI-powered blood tests for ovarian cancer risk assessment are clinically available and have been ordered by physicians more than 200,000 times. Our commercial capabilities include marketing, field and remote sales, market access, and payer relations, and is led by an experienced team of healthcare and diagnostic leaders. In order to propel our pipeline programs forward, we need to invest in capabilities and capacities that answer the call of our research today, but also for tomorrow.
For instance, we need to build out our molecular R&D lab capabilities in order to perform the continuous clinical and technical assessment necessary to maintain our robust AI-powered algorithm sensitive to the accumulated data and continue to enhance the performance over time and data horizons. We need to expand our clinical study capabilities in order to capture the long-term clinical utility data necessary for longitudinal monitoring and prognostic determination, building on industry experience for decentralized trials and patient data collection through wearables and digital tools, and we need to collaborate with pharmaceutical and biotech partners in their quest to bring forward therapeutic solutions and leverage their studies to clinically validate our test as an initial diagnostic for the study enrollment, as well as monitoring the disease progression or improvement on the innovative therapy. Next slide.
Protein biomarker diagnostics are a type of medical test that uses specific proteins found in the body as indicators of disease or health conditions. These proteins are found in various body fluids like blood, urine, and tissue samples. The detected protein levels are compared to reference ranges or established criteria. Deviations from normal levels may indicate the presence of a disease or health condition. Examples of other protein biomarker diagnostics include prostate-specific antigen is used for prostate cancer screening, or levels of cardiac troponin can indicate heart damage. The advantages of protein biomarker diagnostics is that they are non-invasive and often involve less invasive procedures compared to traditional diagnostic methods, and they provide early detection and can potentially detect diseases at an earlier stage when treatment is more effective, and they can be highly specific for certain conditions, improving diagnostic accuracy.
Clinical and patient metadata also plays a crucial role in diagnostic development for several reasons. First, metadata provides essential context for understanding patient characteristics, disease progression, and treatment outcomes, which can identify target populations, select appropriate biomarkers, and evaluate diagnostic outcomes. Second, metadata is essential for validating the performance of diagnostic tests. By comparing the diagnostic results to known patient outcomes, researchers can assess the sensitivity, specificity, and the accuracy of a test. Third, metadata is a critical component of the regulatory submissions for new diagnostic tests. Regulatory agencies such as the FDA require robust evidence demonstrating the safety, efficacy, and clinical utility of a diagnostic test. Next slide. MicroRNAs are small non-coding RNA molecules that play a crucial role in gene regulation.
They bind to specific sequences on messenger RNA molecules, leading to either gene silencing, where the mRNA is degraded, preventing the production of the corresponding protein, or translation inhibition, where the mRNA's ability to produce a protein is blocked. This regulatory process is essential for various biological functions, including development, cell differentiation, and disease progression. Dr. Elias will be going into the microRNA science in more depth in his section of this presentation. Combining protein and microRNA biomarkers offers advantages in clinical applications and presents complementary information. Protein biomarkers reflect the functional state of a protein, such as its activity, modification, or localization, and can provide direct evidence of a biological process or disease. MicroRNA biomarkers are regulatory molecules that can influence protein expression or function and can serve as early indicators of changes in gene expression or cellular function.
By combining both types of these biomarkers, researchers can gain a more comprehensive understanding of the biological processes and disease states and can increase the sensitivity and specificity of diagnostic and prognostic tests. Next slide. Our scientific approach drives our development model, illustrated here. The foundation is an ongoing and carefully managed set of clinical studies. Diagnostic science requires high-quality data. Aspira is currently collecting data and samples from women who are in the intended use groups of our products and proposed products. This is an important study as it reflects the intended use for our multivariate diagnostics. Beyond this, we have strong collaborations and tested processes in AI development, laboratory test implementation, and commercialization, which can accelerate our production of a viable diagnostic test. We work with world-class AI development partners at Dana-Farber and the Medical University of Lodz, and we develop robust clinical platforms.
We have a clinical laboratory and commercialization capabilities to put this all into practice. This all feeds into a cycle of investigation and development, which we have completed previously, the ovarian cancer triage tests to complete the prognostic, diagnostic, longitudinal monitoring, and predictive diagnostic development that we so long to employ. I'd like to now turn over the presentation to Dr. Richard Gersch.
Hi, I'm Richard Gersch. I'm a senior clinical advisor at Aspira, and I'm going to talk to you today about ovarian cancer portfolio and the new data we have published. Next slide. I'm going to focus primarily on OvaWatch with an emphasis on the most recent data. Next slide. I think it's important to ground us a little bit so we're all on the same page here. A pelvic or adnexal mass is discovered incidentally or due to patient symptoms and almost universally elucidated with ultrasound. The combination of clinical information and ultrasound tries to categorize the mass as either benign or malignant, and when it's unable to do that, it falls into this indeterminate category, and an indeterminate adnexal mass, again, refers to one that is either near the ovary or fallopian tube that can't be clearly defined as benign or malignant.
This is a common and complex clinical scenario. It's been problematic, honestly, since when I started my residency a long time ago through my clinical years and continues to be a significant diagnostic problem as well as management. In terms of scale, approximately 20%-50% of adnexal masses detected on imaging are considered indeterminate. That also depends on the clinical setting. But you can see it's a significant number and a significant problem. While the current medical guidelines give some direction for adnexal mass triage, indeterminate mass remains a significant diagnostic dilemma. The imaging assessment of adnexal masses is an area of medicine that has remained largely subjective with little historic use of quantitative metrics. This leads us to the crux of the issue.
If you have a mass that is indeterminate, that is in fact a malignancy, and you're steering that away from surgery, the identification of that cancer could be determined or picked up at a much later stage in disease, which is going to impact on prognosis. The reverse of that is if you think an indeterminate mass is malignant and you refer it to surgery and it's benign, in fact, you're doing unnecessary surgery with those inherent risks. So in summary, the current approach is heavily reliant on subjective inputs and continues to leave room for significant improvement in patient outcomes and healthcare utilization. Next slide. And as a reminder, Aspira currently offers two products to address this unmet need in the management of adnexal masses, OvaWatch+ and OvaWatch.
Now, again, as a reminder, OvaWatch+ is for women who have a current pelvic mass that is planned for surgical management. The test itself has a sensitivity within OvaWatch+ of 96% with clinical assessment, and then the addition of Overa in the reflex process improves that specificity as well to 72%. Now, OvaWatch, in contrast, is for adnexal mass evaluation when the clinical assessment is either indeterminate or benign, but surgery has not been planned. Now, what's important to note here is this test is optimized for its negative predictive value, which is critical when trying to rule out disease, so OvaWatch has a negative predictive value of 99.4%. I'm also happy to report that on October 15th, just a short time ago, OvaWatch gained New York State approval, opening access to OvaWatch to the 10 million women in New York State.
Now, let's turn to some of the data we've generated in support of OvaWatch. Next slide, so in January of 2023, we published our findings in a real-world situation. This was a racially diverse retrospective and a multi-site prospective analysis, and overall, there were 3,000 patients in this study with a population reflective of its intended use, a higher risk cohort, and a lower risk cohort. The results showed OvaWatch provided high negative predictive values of 99% across all the study cohorts, proving its utility as an effective clinical tool to support clinicians in the clinical management of adnexal masses and to safely decrease or delay surgical intervention for masses clinically assessed as indeterminate or benign. Additionally, OvaWatch accurately identified 18 of the 22 malignancies that were missed by the initial clinical assessments, proving its added value to the current standard of care. Next slide.
Now, more recently, in May of 2024, a study was published regarding OvaWatch's potential impact on surgical triage for women with adnexal masses. In this study, 785 patients with samples and clinical outcomes that were on file were reviewed. Their OvaWatch score was calculated and reviewed along with the real-life clinical course, which is a unique opportunity to see what would have happened. In this cohort, we were able to review the surgical decisions and ultimate diagnoses for patients that had that with their OvaWatch score could have been at the time compared to the actual number of surgeries and referrals. Let's take a look at that data. Next slide. Now, assuming that a low OvaWatch score would have led to a decision for clinical management versus surgical management, we saw that utilizing OvaWatch could have led to up to a 62% reduction in patients' triage to surgery.
Now, there's lots of reasons why people will have that surgery. I mean, the most obvious one is patient symptoms like pain, and that takes that group making them a little less interesting. But I want to draw your attention to the asymptomatic cohort. Now, in this cohort, there could have been up to a 59% reduction in surgeries. Now, if you think about that in the context of how this works in the U.S., for every nine surgeries that we do, we'll find one malignancy. Now, this data shows that OvaWatch could help us realize the improvement in that number of patients undergoing surgery. Another interesting feature that we know is that OvaWatch could have done a good job in identifying low-risk masses that the predictability of the resulting triage could have actually improved things.
Now, this is because OvaWatch was identifying the masses that needed to go to surgery. So rather, it was accurately identifying the patients in this cohort that might not have needed to go to the surgery. Without OvaWatch, the reality of what happened to these patients is the chance of finding malignancy was about one in 10, which is right in line with what I just described of nine surgeries for one malignancy. With OvaWatch, that predictability could have been improved to one in two. And this data shows that OvaWatch has the potential to fill this gap and potentially drive down healthcare costs. Next slide. And lastly, the company published a paper just earlier this year looking at the performance of the test longitudinally. For the interest of time, we're going to go ahead and make that available to you and answer any questions during the Q&A.
Now I'm going to turn it over to Dr. Elias.
Hello. I'm Dr. Kevin Elias from the Cleveland Clinic, where I'm the Lillian Seth Harris Endowed Chair for Ovarian Cancer Research and an adjunct professor of gynecologic oncology at Dana-Farber Cancer Institute in Boston. I'm very excited to be here today to describe our continued development with ASPIRA. I've been fortunate enough to work with ASPIRA now for several years on both the ovarian cancer product line as well as now the emerging endometriosis development. So I want to talk about microRNAs as complementary biomarkers for non-invasive diagnostics because this is where my laboratory has really been working for the better part of a decade now. MicroRNAs, if you weren't familiar with them previously, they may have come onto your radar, especially this year, because the Nobel Prize this year was awarded to Victor Ambros and Gary Ruvkun for their work in microRNAs. Interestingly, Dr.
Ambrose and I were previously scientific advisors together for an early microRNA diagnostic laboratory-based company. So our approach to microRNAs is to combine them with machine learning, which, again, well before it became fashionable, we were working on for the last 10 years and was one of the other Nobel Prizes this year. So these two issues, which have clearly entered the public consciousness, are actually areas where we have quite a deep background scientifically. So what are microRNAs? Well, microRNAs are part of what we refer to as the non-coding genome. So these are the pieces of our genetic code that lie in between the proteins, which are known as the coding part of the genome. The microRNAs are a regulatory molecule, meaning that they help determine how our genes are expressed, both when they're expressed and at what levels they're expressed.
We often think of these as kind of the volume dials of our genome. So they help enhance or suppress protein expression at different times. And what's particularly interesting about microRNAs is that they do get out into other body fluids. So they circulate in blood, in saliva, in tears. Really, all body fluids have microRNA levels in them. But unlike other types of RNA, microRNAs are very stable at room temperature. However, they do, like other types of nucleic acids, have the ability to be amplified relatively easily. So we're all quite familiar now with using PCR for the COVID tests that we've all been taking for years now. MicroRNAs can be detected using very similar technology. MicroRNAs now are moved from being a basic science and laboratory tool into diagnostics and other disease states.
And what we know about microRNAs is, unlike other biomarkers that we might pick up, we can correlate them with actual disease biology because microRNAs regulate specific proteins. And so by correlating microRNA expression with protein expression, we can actually pick biologically relevant molecules. We can go on to the next slide. So we first reported that microRNAs in serum, so microRNAs that might be detected in blood, could be useful as an ovarian cancer diagnostic back in 2017. And this was a landmark paper for a couple of reasons. The first was it was the first time that circulating microRNAs were actually posited as a diagnostic for ovarian cancer that could work across histologic types of ovarian cancer and across stages of ovarian cancer. It was also the first paper to bring in modern machine learning techniques, in this case, neural network analysis, to look at microRNAs as diagnostic.
And it really showed that using a neural network approach to measure microRNA expression far exceeded the performance of CA125, which was the protein biomarker that's been used now for going on 40 years. And one of the things that particularly jumped out in this original study was that not only could we detect ovarian cancer generally, but particularly we were very good at detecting early-stage ovarian cancer. And again, our goal is to diagnose ovarian cancer at its earliest stage when it's the most curable. And not only did we pick up these early ovarian cancers, but we could distinguish them from benign adnexal masses, so benign ovarian cysts and lesions, as well as from completely healthy individuals at levels of sensitivity and specificity that far exceeded what were being reported by protein biomarkers at that time. We can go on to the next slide.
More recently, we've taken this one step further. By leveraging the protein biomarkers, which were already being looked at by Aspira in the OvaWatch suite, we were able to combine them with microRNAs and show that bringing these two different types of molecules together actually is more than the sum of their parts, so this was the first paper to look at protein expression and microRNA expression simultaneously in the same samples to combine them using modern machine learning approaches. And what we found is that both the proteins and the microRNAs pick up certain tumors which the other one would have missed, so they're not redundant, so what we found is that microRNAs and proteins are not directly correlated with one another, but the microRNAs which we have selected and the proteins which we have selected both have very high correlation when it comes to prediction of malignancy.
And so if we look at microRNAs alone versus proteins alone versus microRNAs plus proteins along with some of the key clinical data, mostly age and menopausal status, which come with that, we end up with an area under the curve, so a performance of the model at 0.95 on the external independent validation set, which is really best in class when it comes to this discipline, so this far exceeds areas under the curve that have been reported by other potential diagnostic biomarkers.
And importantly, it works not just for high-grade serous ovarian cancer, which we've tested more high-grade serous ovarian cancers than any other technology, but also for other less common histologies of ovarian cancer, non-epithelial ovarian cancers, as well as, importantly, early-stage ovarian cancers, stage one and two ovarian cancers, which is really the diagnostic challenge for the field and what's being demanded by clinicians is that we want to be able to diagnose women who would be missed by conventional tests and to be able to diagnose them at their earliest, most curable stages. So I'm very excited to see that this product is continuing development and that we'll hopefully be getting into the clinic very soon.
This robust approach that we use for combining circulating microRNAs and proteins into a single diagnostic test for ovarian cancer is the same approach that we are now translating into a new diagnostic for endometriosis. And this is what really underlies the technology behind the ARPA-H application, is we've shown that we can combine microRNAs and proteins into a new type of diagnostic, which we will take forward with the same technology and pipeline and methodology into the endometriosis product that we're developing in conjunction with Aspira. And so I look forward to continuing to work with Aspira to translate this technology into a new field for endometriosis, knowing that we've proven that this approach works well and will be robust in its clinical application.
As Dr. Gersch noted, we have two on-market tests that together provide the only comprehensive ovarian cancer risk assessment portfolio for women over the age 18 with an adnexal mass. OvaWatch is indicated for the estimated 200,000-400,000 women a year who proceed to surgery for their adnexal mass. The remaining estimated 1.2 million per year with adnexal masses do not proceed to surgery and instead follow a more conservative watch-and-wait approach, which is appropriate for the patient population for OvaWatch. OvaWatch's longitudinal monitoring feature allows the potential for multiple draws per year, further increasing the potential market size. We are extremely excited about our next phase of the OvaS uite portfolio, OvaInform. As Dr. Elias discussed, this blood test will incorporate microRNAs and provide increased performance for ovarian cancer risk assessment.
This product is targeted to be a true initial clinical assessment for adnexal masses prior to the surgical decision being made. As discussed by Dr. Elias, science has demonstrated that combining serum microRNA sequencing with neural network analysis outperforms traditional protein biomarkers alone. Aspira has extensive experience in AI-developed tests and proprietary algorithms. Our development program combining our proprietary protein biomarker technology with the microRNAs licensed by Dana-Farber continues to progress. Next slide. Our progress on the development of OvaInform continues. This looks different than our prior investor slide as I'm driving to transparency and clarity in the various steps and sequences of these steps in development. Recall, we have an established protein biomarker signature for our commercial clinical diagnostic. Through his scientific research, Dr.
Elias has established the importance of microRNAs, which are differentially expressed in the blood of women with ovarian cancer and can be detected in patients even with early-stage ovarian cancer. We've licensed those microRNAs from Dana-Farber and have been successful in migrating from a research testing platform to a commercial testing platform. We continue with our design verification steps, identifying the necessary inputs and outputs for final microRNA signature determination. Next slide. Shifting gears from our ovarian cancer portfolio, let's focus on our progress in developing an endometriosis diagnostic and reflecting on our recent announcement shared by Nicole regarding our $10 million funding from ARPA-H. Next slide. Aspira Women's Health submitted an application for funding to support our development of our science-backed non-invasive multi-omic endometriosis diagnostic. Endometriosis is observed in 50%-80% of women with pelvic pain and up to 50% of women who present with infertility.
It is estimated that 10%-15% of women in childbearing age live with endometriosis, and despite this high prevalence, disease recognition is inadequate, with time to diagnosis ranging from four-11 years and 65% of women being initially misdiagnosed. Late diagnosis and suboptimal disease management may foster disease progression and adhesion formation that compromises fertility and increases the risk for chronic pelvic pain. Patients are reported to be at a higher risk of other diseases, including ovarian and breast cancers, cutaneous melanoma, asthma, and some autoimmune and cardiovascular diseases, resulting in significant direct and indirect healthcare costs. Next slide. One of the challenges of endometriosis is its diverse symptomatology. Because pelvic pain is experienced in many other conditions with large anatomic variations, patients may undergo diagnostic procedures for inflammatory bowel syndrome and pelvic inflammatory disease.
Transvaginal ultrasound is sensitive but somewhat limited to detecting ovarian endometrioma or deep infiltrating endometriosis. Although effective, MRI is not routinely employed to diagnose endometriosis, but is more specifically used to evaluate cases of suspected rectovaginal or bladder endometriosis. The current diagnostic paradigm endorsed by professional societies requires a patient to undergo laparoscopic surgery. These procedures rely on visualization or biopsy and pathology for diagnosis, a practice that is challenged by heterogeneous lesion appearance, inaccessible lesion location, and surgeon variability. There are inherent risks and extended patient recovery times with these surgeries, and up to 62% of the women will require multiple surgical procedures. No medical device, whether imaging or diagnostic, has yet received FDA marketing authorization or clearance to diagnose endometriosis.
Thus far, biomarkers have not yielded sufficient performance to advance their clinical use, with a number of studies showing that a single or combination of biomarkers cannot diagnose or rule out all endometriosis with high certainty. Our approach is to correct the weaknesses of the current diagnostic paradigm. We have been successful in identifying protein biomarkers that are the signature of endometriosis on the ovary, also known as endometrioma. The addition of microRNA panels specific to endometriosis will enhance the performance of this test to an earlier-stage diagnosis agnostic to disease location or severity. Our ARPA funding will allow us to employ a multimodal approach that tracks disease progression to inform not just the initial diagnosis, but longitudinally may be prognostic or even predictive for endometriosis therapeutic innovation. You may be familiar with our earlier research in protein-based assays for severe endometriosis or endometrioma.
Although our earlier diagnostic is capable of detecting endometriomas with high sensitivity and specificity for women presenting with adnexal masses, we have deprioritized further development of this as a standalone diagnostic in order to focus on the development of EndoInform, which is the multi-omic test designed to identify all endometriosis. Our progress in developing EndoInform continues. Together with Dr. Elias, Dana-Farber, and the University of Lodz, we have identified patterns of altered microRNAs in the blood of women with endometriosis that appears to predict the disease. Once we have downselected these microRNAs, we will enter into a license for these microRNAs from Dana-Farber. We have additionally identified a set of novel serum proteins that are highly associated with endometriosis and show promise to contribute additional diagnostic information and robustness to the test.
We have a long history of diagnostic development using serum proteins, and so this plays well to the strength of Aspira. We continue our work in migrating from a research testing platform to a commercial testing platform, and we continue with our design verification steps, identifying the necessary inputs and outputs for final microRNA signature determination. We know that endometriosis affects not just gynecological health, but immune, hormonal, and endocrine health. We must shift the focus of diagnosis and treatment from a reliance on surgical findings in pelvic lesions to a holistic approach required of a chronic, heterogeneous, and complex disease. Dr. Tamika Auguste, one of our clinical advisors, referred to endometriosis as the ultimate diagnosis of exclusion and a real challenge for physicians to diagnose.
Our research underscores that physicians see value in a non-invasive diagnostic test that would speed the diagnostic process, reduce time to treatment, and determine the necessity of surgery. A non-invasive biomarker diagnostic would be an obvious win for patients who could avoid the invasiveness and cost of surgical confirmation and repeated transvaginal ultrasounds. A readily available diagnostic would accelerate the time to diagnosis and to first treatment. Importantly, as endometriosis is a chronic disease, women cycle between treatments based on improvement or worsening symptomatology and not necessarily physiologic disease burden, and it'll be important to build on our platform and progress the diagnostic to include prognostic and predictive features. We have also proposed a lifecycle of solution that addresses different aspects of clinical need in endometriosis.
Endometriosis is quite amenable to this lifecycle as it is a chronic disease paired with treatments that improve symptoms but do not necessarily affect the progression or severity of disease. With ongoing data collection and analysis, we have the opportunity to associate the dynamics of the algorithm scores or individual biomarkers that coincide with symptom relief or progression. In other words, what do the biomarkers tell us about recurrence? In turn, we believe that time to recurrence can reveal prognostic significance of our algorithm or component biomarkers. Finally, if patients experience different time to recurrence on different treatments, there is a possibility that predictive information and biomarkers can be elucidated.
So we believe that our approach will lead not just to a single point-in-time diagnostic, but actually a diagnostic platform that will build from the diagnostic to a prognostic to a predictive diagnostic, depending on the longitudinal data collection and collaborations with academic centers, integrated healthcare systems, and pharmaceutical and biotech companies. Next slide. As there are no available non-invasive or invasive diagnostics on the market, we recognize that the field is wide open for competitive technologies. However, unlike emerging competitors, our proposed solution is truly non-invasive as it is a blood draw rather than, for instance, a non-surgical endometrial brush sampling.
We believe that being truly non-invasive, but with the high performance expected of a diagnostic, we will not only become the test of choice for physicians and patients, but our ability to recruit patients to longitudinal studies in order to develop the prognostic and predictive tools will be greatly enhanced, and now I'd like to turn it back over to Nicole to wrap us up before Q&A.
Thank you, Sandy. Before we wrap up and open for questions, I do want to take a moment to thank you for your leadership. I knew when you joined the company a few months ago, it would be a real game changer for us. I didn't know it'd be a game changer so quickly, so I appreciate everything that you've done to help get us to this point and everything you're going to do to make sure that we successfully execute.
The whole company is behind you and the R&D team, but I did want to specifically mention what you brought to the table in the process and thank you for that all-consuming work over the last few months. So let's talk a little bit about our market opportunity. I think by now in the presentation, you've heard a lot about the technology, about our capabilities. All of this should be familiar then. So clearly, we've looked at the competitive landscape. We know that we are ahead of everyone else in this space, not only because of the research and the science that we are bringing to the table, but also our experience in reimbursement, in producing and running tests in a CLIA lab, and our business model, our proven ability to drive adoption in a novel test as part of OVA Suite.
So we've simplified our portfolio, and you can see on this slide, the most important update to point out is that OvaWatch with longitudinal monitoring is now fully launched in the market. The research that we spoke about earlier, Dr. Gersch talked about our new research that is helping to drive adoption of OvaWatch. Dr. Elias talked about the research that we have that will support OvaInform, which we believe will allow us to have a test that's clinically useful to physicians earlier in the process of assessing women with an adnexal mass. That technology also becomes part of EndoInform, which will also combine proteins and microRNA biomarkers and will address an even bigger patient need with endometriosis impacting about six million or more women in the U.S. alone.
So we believe all of these put together with the successful execution of our plans that we've described today will result in a billion-dollar-plus annual revenue potential for the company going forward. Next slide, please. In summary, our ARPA-H funding provides us the fuel to complete our development and to commercialize EndoInform. Our capabilities support the development of EndoInform, and our molecular lab buildout will support not only the launch of EndoInform, but also the completion of our research and development and commercialization of OvaInform. So big things coming all around in the development side. We're focused on execution. As I mentioned earlier, Michelle Snyder will be moving into a new role supporting Sandy in the execution of the EndoInform development program. We will be opening up a full search for a commercial leader.
We're very proud of what Michelle has accomplished in rebuilding the infrastructure, building a fantastic team. As we look to a new commercial leadership opportunity, we're going to be looking for someone who can take that great work and that base foundation that we have built in the commercial capability and create that inflection point that we're all working tirelessly to reach on our ovarian cancer program. So with that, I'm going to open the program to questions and answers. We'll be joined for this portion of the session by Dr. Pappas, our head of R&D. So there's a button at the bottom of your screen where you can ask a question. We're going to be taking all of our questions using that method. So if you have a question, go ahead and type it in.
I do have a few that came in already, so we'll get started while you're formulating additional questions. The first question is from Do Kim from Water Tower. Thanks for the question, Do. Todd, I'm going to send this one to you. The question is, are there significant differences in the development of EndoInform versus how OvaInform is being developed other than the associated protein biomarkers and microRNAs?
Thanks, Nicole. Yeah, regarding the development of those two tests, they both incorporate microRNAs and proteins together in interesting algorithms. Really, other than the biomarkers themselves, there's no difference in the way that these will be developed. We'll have protein sides, we'll have microRNA sides, and we'll start combining things.
Sandy, anything to add to that?
No, I think Todd nailed it on the head, and hopefully, the demonstration of the two timelines shows that the programs are running neck and neck in the sense of time and effort at this point. It's exciting to see that some of the financing that we would have needed to raise for the OvaInform product, that benefit will accrue to OvaInform from the ARPA-H funding for EndoInform, which is one of the things that we're excited about in terms of how we can continue to exponentially add to the benefit.
Yeah, and I think, Nicole, just picking up on that, if we were being more specific, I think the fact that ARPA is helping us fund our molecular lab is going to be accretive to both EndoInform and OvaInform.
I think that the experience and consultancy that we'll have with the Investor Catalyst Hub will also lend over to our experience in developing our OvaInform product, as well as just the investment in infrastructure that we're making now with whether it's capabilities, my favorite word, governance and process, but other sort of essentials, foundational elements that'll really help give us some tailwinds, I think, for EndoInform. But to your point, we'll leverage those experiences and learnings over to EndoInform.
Great. Thank you. I have another question related to EndoInform. Just a clarification that we're being asked. With the $10 million investment from ARPA-H, will you have a commercial test in two years? Sandy, why don't you take that?
Sure. So our project plan is built out for a two-year delivery of a commercial product.
Frankly, when you look at the ARPA goals, it really is to bring across winning solutions for women's health within the 24-month period of funding. We are absolutely driving to the two years. Of course, it is research and development, and there may be areas that we can accelerate our progress, and there may be areas where we find we're adjusting our progress. But the goal is to have a commercial launch of a product within 24 months.
Great. Thank you. This one's probably also for you, Sandy. Todd probably has some things to add to it. Will you need a bigger team to launch EndoInform?
Absolutely. And luckily, part of the ARPA funding, it supports the buildout of a broader R&D team as well as support from medical and thinking long-term, even in our commercial organizations.
So we are lean and mean right now at Aspira, but this really fuels our growth focused on EndoInform because that is the deliverable that we've promised to ARPA-H, but also OvaInform will benefit with those capabilities and resource capacity that we build out.
Great. There's a question here about differentiating our test from others in the space. I think I'll let Todd or Sandy, I'll let you talk about it. But Dr. Gersch, I'd actually really love to hear from your perspective from endometriosis in terms of what you've seen and what makes you excited about what we're doing here.
Sure. And thanks for the question. I think it's been sort of the holy grail all along.
And yeah, there are other folks in this space, but the idea of coming up with a biomarker test for endometriosis. I think most people, myself certainly included, believe that if you can do that, the real benefit to patients is earlier diagnosis and better management. Because right now, when you're dealing with an eight- to nine-year delay from symptoms to diagnosis, the belief is that the prognosis is getting altered. I think we're in a very nice position given that we have the experience in the biomarker space to now add the RNA. I think now you're looking at sort of maybe what will be the best of both worlds. I think we don't know. I think Sandy sort of brings that up.
We don't know if we're going to get there, but we certainly seem very well positioned, as far as I can tell, to get into this space with a huge unmet medical need.
Yeah. And if I could just add, I think, and certainly the investors who've been with us for a while know that we had a product that we were moving towards that we found the proteins associated with women with adnexal masses, but those proteins really identified women with endometrioma. And so that's only a lesser percentage of patients that are coming forward with symptoms that are consistent with endometriosis. And so I think building on that experience on the protein side and really finding what protein biomarkers are going to elucidate an endometriosis patient, no matter where that endometriosis is or what stage it is in, is super important.
And then layering on top of that, the microRNA piece is also incredibly important. So boosting the specificity and the sensitivity of the test, I think with the combination of the multi-omics. But I do think our company has an advantage at this point of already having a diagnostic in the commercial space. And so I think one of the attractive parts of our application to ARPA was our ability to have a field force that is already in place, is already familiar with OBGYNs, ready to go when we're ready to launch. And so I think that that's a really critical component. And certainly our competitors, there's good science there, absolutely. I think everyone has the best intent to get an endometriosis product diagnostic over the line to help patients. But it also, it's not good enough just to have a test.
You have to have a way to provide patient access and physician adoption. So I think we're well positioned once that test is coming forward for launch that we will be able to have an impact very quickly.
Sandy, I'd like to add something on top of that too. And something that you alluded to is that we have a test or several tests on the market, and they're algorithmic tests. So we know how to build software based on machine learning and AI algorithms. We know how to maintain those systems, which is really important. And so I think that gives us a distinct advantage in having those commercially available and having the infrastructure to build those and maintain them.
And I feel bad jumping back in, but for one last comment, and that is the other ability to be able to explain to healthcare providers how this works because it is not necessarily as simple as, "Oh, here it's positive or negative." And we live in that space very much with our current portfolio. And I think that scale, the ability to explain to clinicians isn't something that you develop overnight. And I think for us, that's something that we're very skilled at with our team.
I think it's worth mentioning that when we're talking about we, we're not talking about the royal we. I mean, we're talking about the team that we actually have at Aspira, including Dr. Pappas, who's probably one of the most experienced scientists that you're going to find anywhere.
One of the few people who has developed and helped to launch an algorithmic test for gynecologic diseases. And we have a team, and I mean the team that's on the ground currently who can explain to doctors because they're doing it all day, every day with the ovarian cancer portfolio. That has been an important tenet of our strategy from the beginning, which was the ovarian cancer tests, the Ova1, Ova1Plus, OvaWatch. Those tests create buy-in from physicians who needed to learn how to use these kinds of tools. It's very different from what they've had for other disease states. So this is a team of people from one end of the organization to the other that has done it. FDA approved, New York State approved. You can't find too many companies that can say that candidly.
I'm feeling that we have what it takes to get there. And we look forward to actually collaborating with people who have science and have insights that we can leverage as we move forward, but we're feeling quite confident in our positioning.
So do we want to talk about the team any further? I'm going to go back and do a quick look for more questions. Sorry, I shouldn't be answering and moderating. Oh yeah, there's a bunch here. Okay. So Todd, this is a technical question. So I'm going to ask you the question, but I'm going to tell you what I think it actually speaks to. You can answer the question, but I think it speaks to something broader. The question is, with PCR technology, when cycle rates exceed 30, does the amplification of microRNA make it difficult to ascertain with accuracy?
And again, I want you to answer the question, but I think what they're really getting at is, how are we going to make this work with microRNAs? How is that different from what we've done in the past?
Yeah. Okay. Thanks. This is a good question. It is very technical. And it's true that when you use quantitative PCR amplification, especially with messages that are fairly abundant, can tend to top off at a certain area. And that is you lose quantitative information as you continue to amplify the messages. But we're going to be using digital droplet PCR, and that's what we're really excited about because it's a more quantitative method. In digital droplet PCR, we're going to understand the number of copies that we have in an amount of serum. So it doesn't have the same problem in basically having a top end on its quantitative capabilities.
Digital Droplet PCR instead is going to allow us better quantitation, more sensitive quantitation, and better resolution, which means the ability to distinguish these differences much better. We've taken it down the road for Digital Droplet PCR because we felt it would be one of the best platforms to migrate our initial information from. And in fact, we have established feasibility for this platform migration in our initial ovarian cancer product. And we're very excited about how this is going. And we believe that everything will transfer over to all our products.
It's very helpful. Thank you, Todd. I have another question here that is about really the protein biomarkers from the EndoCheck test and what we learned in developing the endometrioma test. The question is, do any of the protein biomarkers for the endometrioma test also play a role in the wider endometriosis diagnosis?
And I know we're not going to get into specific biomarkers here for obvious reasons, but Todd, maybe talk a little bit about how the work we've done so far with EndoCheck actually accelerates the work for EndoInform.
Yeah. And I do believe, yeah, thank you, Nicole. I actually do believe that the EndoCheck project where we've been looking at serum proteins is going to be really helpful for us. There are, of course, methodological problems that it addresses. And I think that we've convinced ourselves quite well that we can detect proteins of interest and we can detect them reliably. And it's something that might seem trivial, but something that you always worry about in any clinical test. There are biomarkers that we've looked at and that other groups have looked at that have utility in detecting endometriosis and especially endometriosis that is more advanced.
And so we think that those may continue to serve a role in the combined microRNA and protein test. We will be testing all of these, and we'll be testing some new proteins that we're really excited about.
Great. So a few questions from the AGP team, Laura Suriel and Jim Molloy. I'm going to ask first question. I think I'm going to start asking you, Dr. Gersch, to take this first. Do you see EndoInform completely eliminating the need for laparoscopic surgeries for diagnosis?
So I think that's more of a question about uptake curve and what does that really look like. And that's the holy grail, right? We would love that. My guess is I don't know that we're ever going to get all the way there, but I think what you'll see is judicious use of it in appropriate patients and expansion.
And I'd like to think one day being able to monitor care with it and how our therapies are working. But I think that's what we're shooting for. I think that's what everybody's shooting for is the ability to do that. I think we want to temper that with a little realism about, could you ever do that? And how quickly could you convert the market to get doctors, healthcare providers to do it? And I think that's going to be another battle.
Dr. Milligan or Dr. Pappas, anything you'd add to that?
Yeah. And I think there's another to add. There's laparoscopic surgery to diagnose, and then there's also therapeutic laparoscopic surgery that some women with severe endometriosis, and depending on the location of the endometriosis, may benefit from that surgery.
So I don't think we'll completely eliminate the need for laparoscopic surgery, but you would like to see a place where, particularly on the severity of the disease and just the length of disease, can you manage with a biomarker-driven diagnostic to help women? And certainly, once we launch and we start to accumulate real clinical data post-market, we're looking to see that this test, how it performs longitudinally. And once you have a longitudinal performance, you might be able to look at a prognostic feature for the diagnostic. And fingers crossed, if we can partner with a pharmaceutical company or two in their development process for their endometriosis therapies, we might be able to get to the far end of predictive.
And so you can imagine, having been at a company where we were running an endometriosis trial, having the inclusion criteria be laparoscopic evidence of endometriosis puts a high burden on the enrollment. And then, of course, I think as Nicole alluded to in other presentations, many of the endometriosis products have a pain endpoint. And so the issue there being, of course, you don't get to go back in at the end of the trial and see if disease has progressed either in location or severity. So if you could, in the future, if we could take a diagnostic and tie it to therapeutic response, it becomes a predictive diagnostic, which I think would be just amazing for women and for physicians who are caring for these women, really understanding the progression of the disease and also when the therapeutic intervention is basically preventing disease progression.
I think there's one other aspect, and I think you brought it up to some degree, and that is, and we do this with our ovarian cancer work, right? It's triaging and deciding who's the most appropriate clinician to see that patient. And this very well fits into that space because those diagnostic laparoscopies are not the same thing as those operative ones. And that's usually a different for some folks' skill set is an entire minimally invasive skill set there. So again, I think that's a more immediate thing that you would begin to see when it rolls out.
Yeah. I'll add to that too. Something we've heard from some of the physicians that we work with, and especially our clinical advisory board, has really helped us to think about it. We can't pretend that laparoscopy is even an option for everyone.
There are plenty of women who can't afford it. There are plenty of women with comorbidities for which it wouldn't be appropriate. Those women actually don't have any option. They don't have an alternative at all. I think, unfortunately, as we've seen, those numbers are going to continue to increase in our younger populations. They don't have insurance the way we did when we were in our 20s, right? There's a lot to think about: comorbidities like obesity, other things that can make it really difficult, challenging, or dangerous to do that type of a procedure. I think sometimes we oversimplify, like, "Oh, we do this for the diagnosis." There are plenty of patients where that's not even an option regardless of its effectiveness.
There's a question about milestones. I'm going to attempt anyway. We'll see if I can do it.
Oh, no, I can't do it. I was going to put the milestone slide back up. You can get it on the website after this. We're going to post them there. But the question has to do with, and Sandy, I'll start with you on this, are there specific key milestones that you think are the most important in terms of if we can't get to X, that puts the entire project at risk? I think when I was projecting it, I was talking about how they're overlapping. They're not really sequential. They're kind of happening at the same time. But what would you say if you were going to look at the various milestones that we have and which are the ones that you would say are the most significant for gating?
Yeah. And I have to say, I don't have the milestones in front of me.
I have a big picture of you in front of me.
I know. I was going to try to share it, but it looks like that ability is no longer available.
No, it's fine. I think with any development program in the diagnostic space, getting to a prototype is going to be absolutely key, making sure that we have the analytical verification, that the test analyzes what we said it's going to analyze, the clinical validation, that the test is relatable to the clinical symptoms and presentation. So I think that those milestones in diagnostic development are absolutely key. When I think about some of the other milestones, and the milestones I think everyone recognized, they weren't a timeline. They're not a timeline-based milestone set. It really is a grouping of activities that loosely fall into different time frames.
But for instance, building out our own molecular lab, let's just say something—I don't know what would go wrong—but something goes wrong and that build-out of the molecular lab is not on time and it's delayed past the 24 months that we're anticipating launch, there are alternatives. We can contract with other laboratories to service that part of the test. I mean, so there's mitigation to that risk. And we are exercising with ARPA-H a risk assessment to really also use external experts to think about any risks that we can identify, whether it's unilaterally or jointly, and how to mitigate those risks. But the test has to work. And I have high confidence just thinking about the protein work that we've done with EndoCheck, looking at just knowing who's behind the microRNA work with someone as strong as Kevin Elias. And that work continues on.
I think that I don't want to be overconfident or overhopeful, but I would think that just like any other diagnostic development program, those are the key areas. But let me let Todd weigh in as well because he really is the scientist and developer of both OVA and Endo.
Yeah. Well, as a scientist and a developer, you did hit upon the two things that I worry about the most, and that is, what are our biomarkers saying about our disease? And I think you also rightly pointed out that we do mitigate some of the risks by looking at this in a multi-omic fashion. We have good evidence that proteins can tell us something. We have good evidence that microRNAs can tell us something. And I think that makes us more confident that we can roll forward with this.
I don't think that there are any single milestone, as I recall them, showstoppers to me. But really, what we're really aiming for is getting to that prototype and showing everyone that this is really going to change the way medicine is practiced.
And since Jim, I know Jim Malloy from AGP was the person who asked that question, I know you're also trying to think about how the funding lines up to that. And since it's not in front of you, I will say that 60% of the milestone payments are attached to deliverables that occur before that prototype milestone. So Sandy did a really strong job negotiating some early milestones, recognizing that if we do have to fund in advance of hitting milestones, we needed to front-load some of those appropriately so that we could keep going.
And I'd like to make sure that I get this across. I'm not sure if I really did in my remarks, but it's important to hear. The excitement around this program from ARPA-H, from the White House, from the Investor Catalyst Hub, from CMS, from you name it, top to bottom is very high. This is considered a breakthrough inaugural program. They are going to do whatever it takes to help us be successful. And that includes helping put their arms around us. If we need help in the design of the prototype, we will have more than enough support to find that help. And the earlier question about competitive products, I don't think any of them are where they could be or should be in order to solve for the problem in full.
But they do give you actually a little bit of comfort that we're most certainly on the right track, right? So I think what we're going to build is better, but I'm encouraged to see the other research, and it does help us feel confident that we're on the right track. But there is a high degree of motivation to make these launchpad programs successful in the timeline that we are given. And so there's a lot of support for us along the way. Hopefully, that answers the question that you have. And I think there was also a question about, will more funding be required than the $10 million? At the end of the 24 months, will there be more funding? I'll take that, Sandy, and you can tell me how I did. The answer is yes.
So the launch of the product in two years, as we've learned from our experience with the ovarian cancer portfolio, the launch is the start. There's a lot of work to do from there. So there will be some post-launch marketplace activities required, as there always is. We'll certainly want to continue to validate the product clinically. We'll certainly want to continue to gather clinical utility data. What's exciting to me is that a lot of the conversations that we have had to have post-launch with other products to understand what's required post-launch, we're going to have those earlier because we're going to have access to the decision-makers at the payers, at the providers, at CMS, etc., etc.
So we can have a better sense of what needs to be spent, how it needs to be spent, and that it will result in some outcome that has an ROI to it, right? That's been a real struggle for diagnostics overall. We're not special in that way. We've all struggled with that. And I think that recognition that we need more help to be successful there is part of the goal of the ARPA-H program. Sandy, would you—you're nodding so you're doing okay, but go ahead. Jump in.
No, you did great. No, the only thing I would add is layering on our ambition to bring forward a diagnostic that includes the longitudinal and all that includes the prognostic and the predictive factors. We don't want to be just a one-time diagnostic.
We have broad ambitions to support a woman throughout her journey with endometriosis, knowing that this is a chronic disease. So that will take additional funding. And I think it also depends on what channel we go down commercially, where we head. I think our marketing budget, I mean, I know that our commercial leader could use a little bit more capital all the time. They always have ways to spend it. But I do think that we have enough money to get the product over the line for commercial ability within the 24 months.
Great. That's all the questions that we have, which is good because it's also all the time we have. Any last comments from anyone else of the speakers?
Otherwise, I just want to say thank you.
Oh, go ahead, Sandy.
I was just going to say I'm super excited to see so many people turn out.
There were folks from Aspira that joined us today, which is just fabulous. And of course, the investor community and other interested folks. So super excited to have the support of everyone on the call.
Yeah. I have two things to say before we close. First, I know there are still a number of, I think almost the whole company joined today, which is so exciting. The excitement level in this company is off the charts. I mean, we are going to work tirelessly day and night to make sure that we are hugely successful here. It just feels so good to look around and see there's a little bit of an extra skip in everybody's step, I guess, I would say. So that's number one. And I should say thank you. If you're still on, thank you so much for everything you did to make this a successful application.
We're going to get, we're going to do great things together. Also, I wanted to point out that we have been asked to host in our Connecticut offices a press conference this Friday with Representative Rosa DeLauro, who most of you may know is an ovarian cancer survivor, but just a women's health champion from start to finish. She'll be coming to Connecticut. We've invited some of our other key stakeholders in Connecticut, including Representative Gilchrist, who on the state legislature put together an endometriosis working group that's honestly, there's nothing like it anywhere in the world. She's brought together stakeholders from all different states, not just Connecticut. So if you're able to join or to pay attention to our social media, we'll have some great information that comes out of that. And there's a lot more to come.
So hopefully, we'll see all of you on our earnings call, which we're going to announce the date here shortly. And we're back to work. So thanks again so much for joining.