Good afternoon, welcome to the Aspira Women's Health Investor Day. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the Q&A text box at the bottom of the webcast player or by emailing your questions to questions at lifesciadvisors.com. As a reminder, this call is being recorded and a replay will be made available on the Aspira website following the conclusion of the event. I'd now like to turn the call over to Nicole Sandford, President and Chief Executive Officer of Aspira Women's Health. Please go ahead, Nicole.
Thank you. Hello everyone, and welcome. Let me start by thanking you for taking time out of your day to join us. We're really glad you're here. We've created a presentation that we believe will be interesting to both new and prospective and existing shareholders. I was thrilled to see that we had plenty of both registered for today's event. If you're a new or prospective shareholder, I hope you'll leave today's presentation impressed and inspired and glad to be a part of what we're doing to change health outcomes for women. If you're an existing shareholder, I hope you recognize the evolution of our products into a cohesive portfolio of solutions for gynecologic disease detection and risk assessment.
We are, we believe, poised for breakthrough growth, and I think you're gonna see why we feel so strongly about that as we move through today's presentation. Regardless of what brought you here today, I hope you see how Aspira is bringing optimism and hope in two areas of women's gynecologic health that have given us very little reason for both of those things for a long time. We're glad you're here and we're happy we were able to pull together what we believe is gonna be a very enlightening and informative discussion. It's a very proud day for me and for the rest of the executive team. We've been working towards this presentation since the day I got here a year ago February. I thank everyone who's been on the journey with us.
Again, welcome everyone to the discussion. Let's go ahead and move to the next slide, and we'll just review the agenda for the call. Well, first, the usual safe harbor. Just to remind you, we will be talking about forward-looking information and suggest that you take care in understanding and doing your diligence and by looking at our publicly filed documents. You can go to the next one. We have two wonderful invited guests, clinicians and researchers that are joining us today to offer their insights on Aspira test portfolio. Dr. Tamika Seay, who is an obstetrician and gynecologist, founder, owner of Advanced Women's Care Center in Atlanta, Georgia. Dr.
Kevin Elias, who's Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at the Harvard Medical School and Director of Gynecologic Oncology Laboratory at Brigham and Women's Hospital in Boston, Massachusetts. Thank you both for being here today. We really appreciate your time and input. You can go to the next slide. Of course, two of the leaders within Aspira, Dr. Charles Dunton, who has been an integral part of the development of our entire portfolio, has been a trusted advisor to Ryan and the entire R&D team. He's joined us. He was recently shifted gears from being our interim chief medical officer to agreeing to chair our scientific advisory board. Thank you so much, Dr. Dunton, for continuing to support the work we're doing. And Dr.
Ryan Phan, who is our Chief Scientific and Chief Operating Officer, and someone who I've talked a lot about in the past. For those of you who have been with us for a while, he is no stranger. He'll also be talking quite a bit about the developments we have across the portfolio. With that, let's talk about. We've missed the agenda. Can you just go back and see if we somehow hopped by it? I think it was before this one, hopefully. Hmm, no. Okay. Let me just tell you what we're gonna cover. You can keep going, Tara, down to the slide you were on.
Just to give you an audible of what we'll be talking about today, we'll be covering our ovarian cancer product portfolio. We'll give you an update on Ova1 and how it's being used in the in practice. We'll also then talk about the pending launch or expansion of Ova1 as a serial monitoring test for mass monitoring. We will then move into apologies. First, then we'll talk about the expansion of our ovarian cancer portfolio through a recently announced licensing agreement with the Dana-Farber Cancer Institute. Before shifting gears and talking about endometriosis, Ryan will talk about the exciting developments and where we stand in terms of launching EndoCheck prior to the end of this year.
We'll give you an update on the sponsored research agreement that we have entered into with a consortium of world-class research and academic institutions that's being led by Dana-Farber. More to come later in the call on endometriosis. Quick update for those of you who are not familiar with Aspira. We are a company that is dedicated to improving health outcomes for women through the development and distribution of technology-enabled tools for diagnosis of gynecologic disease. We are the only company that I'm aware of, that is exclusively focused on gynecologic disease. We have a lot of reason for optimism in terms of our investment profile. Starting with the fact that we have commercial tests. We have revenue-producing blood tests that are processed in our own CLIA-certified laboratory environment.
We've seen strong growth every quarter since I've joined the company. In 2022, we saw a year-over-year volume growth of 23%, revenue growth of more than 20%, and margin growth of 18%. As you're about to hear more today, we have a portfolio of both existing and expansion opportunities for our product portfolio. The two commercial tests are Ova1Plus, which is a combination of our two FDA-cleared tests, Ova1 and Overa. That's used for surgical management of masses. OvaWatch, which was launched in December of last year, a blood test for initial clinical assessment of indeterminate and likely benign masses. 2 in development tests. One is an expansion. It's actually the same test, OvaWatch, but an expanded use for serial monitoring. That's planned for later this year.
EndoCheck will be the first of its kind diagnostic tool for endometriosis, and that's also coming before the end of the year. A lot of exciting developments that we'll be talking about today, in process for the rest of 2023. We continue to focus on reimbursement and managed care. Ova1Plus, it has Medicare reimbursement at a rate of $897. We're in the process of seeking crosswalk of coverage for OvaWatch. For Medicare, we have a unique PLA code for OvaWatch, which went into effect on April first. We have continued to look at strategic expansion of contracts with commercial payers and Medicaid around the country, which aligns with our mission to bring our tests to any woman that needs them. We have an experienced management team.
We have completely rebuilt the team since I joined the company last year. When I was looking for people to join, I focused on mission-driven executives, but people with proven track record in our industry, with micro-cap companies that have done what we've done before and have proven their ability to move quickly in challenging environments. I'm very, very proud of the team that we've put together, including our recent announcement of our CFO, our new CFO, Torsten Hombeck , who's going to join us in early June. You can go to the next slide, please. This is a snapshot overview of our portfolio. You'll see the two products all the way to the left I just talked about, OvaWatch and Ova1+. Those are the commercially available tests that we have today.
The rest of the tests on this page are planned expansions to those portfolios. We branded our ovarian cancer test as OvaSuite last year, announcing our intention to own the patient journey for ovarian cancer. We continue to look for ways to expand and enhance that portfolio. Endometriosis, second disease state that we're focusing on, we have two tests in process, both EndoCheck and EndoMDx. We'll be talking about all of these products today. You can go to the next slide, please. Just a quick overview of OvaSuite. These are the two existing tests. I'm gonna hand it over to Dr. Dunton in just a minute to overview the current standard of care. Dr.
Seay will talk about how she's used our existing tests, OvaWatch and Ova1+, in her practice to make a difference for patients. A new milestone that we can happily talk about, we've now processed or physicians have ordered more than 80,000 tests within the OvaSuite portfolio. Very exciting. That means we've touched the lives of 80,000 patients. Now we have a tool for all women who present with an adnexal mass, so exciting milestone for the company. I think with that, I'm handing it over to you, Dr. Dunton.
Thank you, Nicole. I'm gonna talk about ovarian cancer, and Dr. Seay is going to talk about how she uses the test as a gynecologist. I'm a gynecologic oncologist. Can I have the next slide? What is the issue here? We have a lot of adnexal masses. An adnexal mass is anything that's beside the uterus, the ovary, the fallopian tube or surrounding tissue, and almost 20% of women will have an adnexal mass at some point in their life, and they're almost always benign. However, if there is a malignancy present, getting the patient to a gynecologic oncologist has been shown to improve not only the care, but the survival of 25% survival advantage if you get the woman to the right surgeon who's a gynecologic oncologist.
Healthcare providers need a reliable, non-invasive tool to distinguish these two things. You know, there are maybe over 1 million adnexal masses diagnosed, usually on ultrasound, and there's 200,000-400,000 adnexal mass surgeries but only 20,000 malignancies. It's important that we have tools to find where we're at and get the patient to the right thing. You don't wanna send all these to gynecologic oncologists because then you'll be operating on benign cases and they may cause a surgical backlog. Next slide. The problem is really an indeterminate mass. You'll see ultrasounds where it's most likely benign, a simple cyst, and you can watch for waiting with that patient or manage their symptoms. Many of the surgeries are done because the mass is causing pain.
You can go to clinical management and follow the patient up. Likely malignant on an ultrasound should be referred to a gynecologic oncologist and undergo surgical management by that person. In the literature, it says that there's 25% of masses are indeterminate. We have data that shows that in most clinical settings, and this has been my experience, that when I get an ultrasound report, it's not definitive in most of the cases. What's the risk if they're wrong and the cancer is not detected on the ultrasound? What's the risk if a woman has to undergo surgery for an indeterminate mass, most of which are benign?
Next slide, please. We looked at over 1,200 radiology reports from, you know, known surgical specimens that were part of Aspira, you know, previous studies. We had them reviewed by 2 of 5 experienced clinicians. 3 of us are GYN oncologists, 2 of us are long-term practicing gynecologists. There are ways to look at ultrasounds with certain simple rules, but they're generally not used in the community. When we looked at these, we found that over 50% were agreed by both reviewers to be indeterminate, 548. This is where biomarkers come in to help clinicians decide, do I have to send this patient to a gynecologic oncologist? Can I follow them? Can I operate on them?
This is where the problem is that this is a real-life experience. This was presented at the Society of Gynecologic Oncology recently. Next slide. Without a good diagnostic tool for patients, if a malignancy is present and it's considered a low risk, there could be a delay in treatment leading to worse outcomes. If the patient is high risk and there's no malignancy present, maybe unnecessary surgery or longer wait times for needing specialized care. For physicians, this means lower quality of care, referrals of patients out that they could care for as a gynecologist, and for healthcare payers, higher costs for unnecessary surgery or cost of treating advanced care. I'd like to turn it over to Dr. Seay to explain how she uses these tools in her practice. Next slide.
Dr. Dunton. Thank you so much. As Dr. Dunton discussed, the OvaSuite products that are in usage now in private practice, including the Ova1Plus, as well as OvaWatch. Just as Dr. Dunton suggested, these are for patients who come in with the suspicious lesions, suspicious adnexal masses. We, as the general gynecologist, are trying to figure out where exactly does this patient go? Does this patient need to be managed by the general gynecologist and surgery? We need to wait to perform surgery because this patient obviously potentially may have an indeterminate or a benign mass, or do we go ahead and send those patients over to our colleagues like Dr. Dunton and perform surgical management for them because of their suspicion for malignancy is much higher.
Today I'm gonna talk with you more about how we use these in our clinical setting here in a private practice office with a generalist. This slide just talks about the typical management that a patient will come into the office who has a potential suspicion for ovarian cancer or adnexal mass in general. Patient usually comes, and they usually are complaining of some vague symptoms, abdominal bloating, sometimes pelvic pain, pressure. These symptoms are recurring, so that's what brings them in to see their gynecologist. Of course, by this time, they've already gotten on the Internet, and they've started to research potential reasons as to why they're having this pain. Of course, it could be due to IBS, it could be cancer.
Of course, the patient now is extremely frustrated, confused, and anxious about the symptoms that they're having as they present to the gynecologist. Of course, they go in, they get an exam that may or may not be, you know, show any signs, may be completely unremarkable. Then, of course, the gynecologist at that time will go ahead and put ovarian cancer on a differential diagnosis. Usually we'll perform some other blood tests, get an ultrasound, to kind of understand exactly what's going on with the patient. While the patient's waiting for her appointment, the patient starts to worry, consults family and friends, Dr. Google, of course. We get the ultrasound results back, and we see that the patient has a 6-centimeter adnexal mass.
There are some features of it that look possibly could be suspicious, but overall, the lesion doesn't look overtly malignant. This is where the problem for the general gynecologist comes in as to whether or not this is something we take care of here in our office or is this something that we will send to a GYN oncologist for further management and treatment. We rule these adnexal masses as indeterminate. Of course, unfortunately, many providers are gonna say, "Hey, it's better to be safe than sorry," and go ahead and schedule surgery, and usually we'll perform a bilateral oophorectomy at that time because of the adnexal mass and potential risk for recurrence of another adnexal mass on the contralateral side.
That goes back to Dr. Dunton's slide, where he showed that, you know, we have all of these adnexal surgeries, but the majority of them are likely benign and very few of them are malignant. Next slide. How does OvaWatch change our ability to give these patients a different perspective? Maybe this patient does not necessarily need to go to surgery. Are there some parameters? Is there a test? Is there something that we can do to determine whether or not this patient needs to have a surgical intervention or can we do, quote-unquote, watch and wait? At this time, the patient has this 6-centimeter mass, is ruled indeterminate. In this patient population, we would order OvaWatch. That's to confirm malignancy risk.
You wanna, of course, order the OvaWatch, and this will allow for you to have a good low probability for malignancy. When we order this test, this is for patients that we are triaging to not perform surgery because there's nothing that is overtly concerning. The patient may have some vague symptoms, but there's nothing that is pushing you to take the patient to the operating room. Is this mass something that I can just watch and wait? The OvaWatch is perfect for those patients. Because it allows for them to have a little bit more definitive information about the mass without necessarily feeling as though they are waiting for ovarian cancer to occur, so to speak. What does this do for the patient? Next slide. This is getting into our Ova1Plus.
Go back to the next slide for me, please. Sorry about that. Yes. Other things that patients may note that could be beneficial. Of course, this decreases unnecessary surgical procedures on patients with likely benign disease. Keeps Dr. Dunton's office free and clear of a lot of benign adnexal masses, so he doesn't get that backlog and take care of patients that actually truly have cancer. Allows for there to be actual data, like I suggested, to support the decrease or delay of the surgical procedure. Also allows for there to be increased patient satisfaction. This is also very important for patients as far as their lifestyle is concerned, as far as, you know, being able to take off work, loss of pay, loss of work, having to schedule surgery.
These are things that patients, you know, have difficulty with. If we have a test that allows for them to feel a little bit more secure about, the findings that we find, and not have to undergo surgery, this is also beneficial for the patient. OvaWatch, which I think is probably even the most beneficial in the private setting, is that you have patients that are truly not excellent surgical candidates. You want to make sure that you are doing what you need to do in order to make sure that the patient doesn't have ovarian cancer, you know, do the OvaWatch screening. These are patients that you kinda wanna watch and wait because they're not the most excellent of patients, as far as surgical intervention. They may be, you know, morbid obesity.
They may have issues with diabetes control, you know, severe hypertensive. These are patients that have a high comorbidity for anesthesia. These are gonna be the patients where you may wanna provide an OvaWatch to say, "Hey, we likely think that this is benign. Has an excellent negative predictive value of 99%." We can watch and wait until symptoms either progress or a resolution of the cyst occurs. Next slide. The next topic we're gonna discuss is the Ova1Plus. Let's say you have that same patient. We have that 6-millimeter mass that we've been watching with OvaWatch. After 4 years of stable follow-up with the patient, she starts to now have severe pelvic pain. Surgery is actually indicated for the patient because the pain has worsened. We do another transvaginal ultrasound.
We see that the mass has gotten larger, but it still does not show an overtly malignant potential to it. It still falls in that potential indeterminate range. In this situation, an Ova1Plus would be beneficial because now you are triaging the patient to surgery. Now we really need to know whether or not the surgery needs to be performed by a generalist or do we need to go ahead and send that patient over for a consultation with a gynecologic oncologist. Next slide. This is an actual patient from my office where I have actually utilized Ova1Plus. This is a patient, 51-year-old Caucasian post-menopausal woman who presented with severe bilateral lower quadrant abdominal pain. She had a previous hysterectomy that was performed with a right oophorectomy. She presented to the emergency room.
She had a CT scan that was performed that showed acute appendicitis, actually. They also saw this left ovarian cyst that was about 4 centimeters. Patient was taken urgently for a laparoscopic appendectomy by this general surgeon. They saw the cyst during the surgery, but they're like, "Okay, she can just follow up with her, with her primary GYN for that. We don't see a need to have a GYN come in as a consult for this cyst." She came back into the office after her post-operative recovery from her appendectomy, and she was still having pain. We repeated the ultrasound in our office and saw a 4.2 centimeter ovarian cyst with some hypervascularity and daughter cyst.
These are those signs that there could be something suspicious going on, but there's not enough definitive information to say that this is overtly malignant. Patient still, of course, complained of pain and desire to have surgical intervention for the ovarian lesion. An Ova1Plus was ordered for the patient. Next slide. Her results actually came back. Her score was 4.7 with a reflex Overa that helped with the sensitivity and specificity with a score of 5, which was an elevated risk for her age population and for the signs that we saw via ultrasound. She actually had an ovarian cancer risk of about 5-16.5%. At this time, this was my cue to send her over to a GYN oncologist for additional evaluation.
This was not gonna be a ovarian mass that I wanted to embark upon because if it was ovarian cancer, of course, we want her to have the best definitive surgical management that she can. That would be via a gynecologic oncologist. Her final pathology actually was still benign. It came back as a cystadenoma. Next slide. The next presentation will be Serial Monitoring and Research Update by Dr. Phan.
Thank you, Dr. Seay. Thank you, Dr. Dunton. You all, thanks for everyone listening. You just hear the two commercially available product from Aspira, and we hear from perspective from two clinicians. One is a gynecologic oncologist, and the other one is a general gynecologist. You can see that how the portfolio been utilized in the clinical practice. What I'm updating you for the next step will be the OvaWatch Serial Monitoring . What does that mean? As you hear from Dr. Tamika Seay, currently you have an approach that the patient when, if they're not candidate for surgery, they can be, quote-unquote, on a wait for a wait-and-watchful approach. There is currently no available clinical assay to support clinician to monitoring these adnexal masses.
OvaWatch we intended initially as a one-time use, but as you can see, we have a potential to extend the application into the mass monitoring process. In fact, OvaWatch will be the only clinical assay available to assist provider to monitoring this patient with adnexal mass that are not selected for surgery for several reasons, like Dr. Seay mentioned early on. We are continuing to monitor and peri-periodically collect a blood sample from patient enrolled in this clinical study to support patients that are being managed non-surgically or have been wait-and-watch approach. We plan to submit our manuscript for this study in sometime in Q3 2023, and expand our application of OvaWatch to serial monitoring test later this year. Next slide, please.
What it looks like for an OvaWatch clinical report when the application for serial monitoring look. In this example, it's not the real patient report, but you can see the patient will be collected a blood several times a year to monitor their adnexal masses. Physician will receive this report indicated the OvaWatch score would correspond a negative predictive value at the time of the patient being tested. In this plot, you can see beside the most recent update OvaWatch score, physician can also see the previous testing patient, OvaWatch score. Allow the provider can monitor this score trends over time to support that how to medically correctly manage the patient, whether they should be continually monitor or they should be a candidate for additional workup, including, for example, MRI or repeat ultrasound if you need it.
or a patient with genetic testing, including assessment for patient family history as well. This will be the first clinical assay support provider in this aspect of monitoring the patient presented with adnexal mass not selected for surgery. Next slide, please. In addition to the planning for expanding the OvaWatch as serial monitoring assay, I'm happy to share with you that the company recently have three abstracted abstract accepted for publication in ASCO meeting coming up in a few days. Listed here is the three abstract available to view on ASCO website. Number one is show that OvaWatch is reduce the surgical backlog through the reduce of preventive surgery for ovarian cancer, because of our risk assessment that allow that approach for clinician to triage whether the patient should wait or should be considered for additional work-up.
The second abstract that been published in ASCO meeting this year will be to show that the progress of our serial monitoring study that will be fully submitted and a manuscript for peer-review publication later this year before we launch in OvaWatch serial monitoring. The last, the third abstract that have been accepted for publication to show that OvaWatch is actually performing superior compare to any available ovarian cancer risk assessment of indeterminate mass available in the market today, including some of our known individual biomarker as well as other combination of biomarker. We show that actually OvaWatch monitoring the patient with a low risk of ovarian cancer more accurately than any available tool. Next slide, please.
Before I move forward with the microRNA and ovarian cancer, basically this, you will hear in the next few minutes from our collaborative investigator, Dr. Elias, at Harvard, about the platform that we're exploring to see how the new molecular-based technology can contribute and even enhance the performance of our current ovarian cancer research assessment portfolio. I will turn over now to Dr. Elias.
Thank you, Ryan. I'm really excited to be able to share some information about our research collaboration with Aspira. I'm gonna talk about different class of molecules that may not be familiar to some of those attending today, which are microRNAs or miRNAs. We really look at these as complementary biomarkers to traditional non-invasive diagnostic technologies. Now, for an introduction for microRNAs, it's important to understand how the human genome is constructed. When we think about the protein coding part of the genome or what we're usually referring to as genes, there's regions of DNA which actually results in a protein, that's less than 3% of the human genome.
The vast majority of our DNA is actually comprised of what are called non-coding regions of the genome, and some of those do get transcribed, meaning turned into RNA, pieces of messenger. Those fall into either small non-coding RNAs or long non-coding RNAs. Now, here I'm talking about the small version of those, and these are what we know as microRNAs. microRNAs are sequences of nucleic acids, usually from about 18-25 base pairs in length. Now, the way that microRNAs work is they're sort of like copyright editors of the genome. They bind to the messenger RNA, which codes for proteins, and they will prevent those messages from actually reaching the ribosome being turned into protein. Now we know that microRNAs have several advantages over protein diagnostics. One is that they're detectable in all body fluids, including blood.
Unlike circulating DNA and other types of RNA, they're extremely stable, even at room temperature. You can leave microRNAs on the benchtop for several days, and they won't degrade. Like most nucleic acids, however, they have a detection advantage in that they're amenable to amplification through PCR. We can take very, very small quantities of microRNAs and detect them using amplification technologies. That also allows them to be multiplexed quite easily. Because we can match the sequence of a microRNA with the protein coding sequence that it targets, we can actually correlate these to disease biology. We can pick microRNAs that we think are quite likely to be involved with, say, ovarian cancer biology. Next slide. In my laboratory, we have shown that microRNAs can be used to identify cases of ovarian cancer.
We described this in a publication originally from 2017, where we looked at the ability of microRNAs being analyzed through a neural network type of machine learning compared to a traditional protein biomarker like CA 125. We found that the neural network using microRNAs significantly outperforms CA 125 in terms of picking up which women have ovarian cancer and which ones don't. Unlike CA 125, microRNAs are particularly useful in both pre and post-menopausal women. One of the problems with traditional protein biomarkers is that they tend to be much less specific in pre-menopausal women.
We then followed this up with an independent study of 275 subjects, 75 of whom had only early stage ovarian cancer, so stage 1 and 2 cancers, 100 women with benign types of adnexal masses and 100 healthy controls. We found that we were able to diagnose about 3/4 of the very early stage ovarian cancers, which again, are typically very difficult to diagnose with protein biomarkers and had high specificity for distinguishing these from benign types of masses or otherwise healthy women. This microRNA technology is now part of a patent that we've reached an agreement with Aspira for licensing in order to bring it into the market. Next slide.
Now what we're working with is how do we take the existing Aspira portfolio and improve that by adding in microRNAs. Here, we performed a study looking at more than 400 test subjects with 10-fold cross-validation to see what happened if we combined microRNAs with protein information. What we can see is that when we have both microRNAs alone or protein and the clinical metadata alone, those work fairly well. When we combine all three of them together, we were able to boost that sensitivity quite considerably. What we're mostly picking up are the earlier stage ovarian cancers, as well as ovarian cancers in some of the less common histologies, which make up about 15%-20% of all ovarian cancer types.
Can I take the next slide? Hand it back over to Ryan, please.
I think this one is me.
Wonderful.
Thank you so much, Dr. Elias. Appreciate you being here. Obviously, our partnership with you and with your team has been extremely rewarding for all of us. We're excited to see how our portfolio can continue to evolve and help women, as you said, that have either rarer cancers or are pre-menopausal. I talked earlier about rebranding our portfolio as OvaSuite. This is one of the reasons that we did that. We want to keep looking for ways to enhance the performance of those testing tools. Appreciate the opportunity to work together, and we're looking forward to taking the next steps with you.
We're gonna shift gears now and talk about endometriosis, and I'm gonna give a quick overview before I hand things over to Ryan to talk about where we are in the development. For those of you who don't know, endometriosis is a debilitating disease that affects more than 6 million American women. That's an estimate of how many women right now are walking around with this terrible disease. It's a condition in which tissue that is similar to the lining of the uterus grows outside of the uterus, and continues to behave the way it did when it was inside the uterus, which causes a lot of issues and problems for women, including pain, excessive menstrual bleeding, digestive distress, and if left untreated in the long term, can cause infertility.
Right now, the only way that endometriosis can be diagnosed is through an invasive procedure. Laparoscopy provides strong sensitivity at 90%, little less strong on specificity, but still 40%. That is the only existing way for a clinician to diagnose a woman with endometriosis. We've heard over and over again, clinicians, patients, everyone is looking for a non-invasive alternative with similar performance. That is the goal. That is what we have been working towards. And it's even more exciting now because there's been developments in terms of therapies that are available to treat women with endometriosis. There's 2 that are mentioned here, one from AbbVie and one from Myovant.
This is exciting for us because not only are we looking to provide a diagnosis that doesn't require an invasive procedure, but we recognize that patients who want to take advantage of these new therapies need to be diagnosed in order to secure coverage for those drugs, which can be quite expensive. That represents an additional opportunity for a non-invasive diagnostic aid like the one that we've been developing. You can go to the next slide, please. I'm not gonna spend a ton of time talking about endometriosis, because you can learn an awful lot with a quick Google search. This is a top of mind issue for women. It affects a lot of women. In addition, there are a lot of women who think they have endometriosis as well.
you know, pelvic pain, which is something we have a lot of experience with, you know, we see a lot of conversation about endometriosis out there. You can go and look yourself, but this is a top of mind issue for women, and we know that there is a clamoring from the marketplace for a better alternative. Ryan, I'm gonna hand it over to you so that you can talk more about our position to take advantage of this opportunity and the development of our products.
All right. Thank you. Thank you, Nicole. Next slide, please. As you see, you know, endometriosis is one of the diagnoses, one of the greatest unmet need for gynecologic disease right now. Why we believe that Aspira is in better position to tackle this issue. The reason for that, because we familiar work and utilize with FDA-approved platform throughout our process with various experience in both, develop FDA-cleared assay as well as, lab-developed tests that have been proven to be successful in term of both technology and application for patient care.
On top of that, unlike most of the company in this scale, we have a highly regular environment, in fact, that with a clear certified CAP-accredited clinical laboratory setting where we perform testing for patient, but at the same time also validated any new product in that successfully. For that, embody on the Aspira enormous experience in this field, we believe that EndoCheck will be a life-changing experience for patients who have endometriosis symptom. As you hear earlier on from Nicole, these diseases would take 6 to 9 years, sometime even longer for patient to be accurately diagnosed. Several times require surgical intervention to find out that actually a patient have endometriosis or not. The burden of healthcare on that is tremendous for this patient.
we will be the first to launch in a product, is a non-invasive blood-based that utilize in multiple differentiated biomarker where we have experiences. we developed the proprietary algorithm based on Aspira technology, this will be unique to Aspira with a blood-based assay. The development of this assay is from what, patient with and without endometriosis as a control cohort. we have a histology confirmation for this patient when we develop the assay, we have been utilized at the very last cohort, I will tell you in few minutes. the assay will be validated, has been validated, tested in a CLIA certified environment where we'll be performing the commercial testing. Next slide, please. before I talk a little bit about this, first time, presented here the performance of our in-development assay.
I want to remind a few people on this call may be familiar with. When I joined Aspira with a mandate to lead the innovation team to launch OvaWatch, both in term of one-time use as well as a serial monitoring assay for lung cancer assessment. I also have at the same time, leading the team to innovate, develop, and testing the endometriosis, and then go back and review, investigate it, and learn from our past experience as well as some other what would work and what would not work. Why I need to express that? This assay, it's these are complex diseases, heterogeneous population. The clinical symptom may be overlap with other diseases. We have learned so much through our development. We expand the spectrum of our biomarker in this assay development.
We optimize and we test the signature into appropriate qualified patient and control cohort. This signature have been developed with appropriate large patient cohort for improve both effectiveness and efficiency. We believe that our test result will provide a highly reliable result to support clinician to accurately diagnosis without intervention by surgery. I show you a snapshot where here the in-development EndoCheck assay performance. Our assay at the sensitivity and specificity is outperform the current standard practice of laparoscopy. On the right side, you will see a range of specificity and sensitivity of this assay. We will optimize them with the intended application as we see fit. We believe this assay will be the life-changing for diagnosis for patient with symptom.
Also qualify those patients to be available for medical coverage by approved medication available on the market at this point. Next slide, please. What the timeline for this launching of EndoCheck? EndoCheck is currently being validated in our CLIA lab. That will be the same lab that process commercially when available for the assay in later this year. Completion of validation is anticipated in Q3. We supported with our multi-cycle clinical study that launched last year. We'll provide additional clinical data to support the launch.
We plan to submit the manuscript before the end of the year, the study will be continued throughout 2021 beyond to support additional endometriosis products, including, you will hear in the next few minutes in our collaboration with a consortium academic institution led by Harvard Dana-Farber Cancer Institute. Currently, the commercial activity related to reimbursement, pricing and marketing, and partnership are in process. Next slide, please. Now I will turn back to Dr. Elias to discuss a little bit the future direction of microRNA and endometriosis.
Thanks so much again, Ryan. As I mentioned before, my laboratory here at Brigham and Women's and Dana-Farber, we really focus a lot on microRNAs as novel diagnostic tools across a lot of diseases. A lot of the lessons that we learned in developing a microRNA assay for diagnosis of ovarian cancer, we've been able to bring those same technologies to bear when it comes to the problem of diagnosing endometriosis. Can I get the next slide, please. We've learned over time kinda how to make a pipeline along around this. We started with building a classifier that would combine microRNAs and protein and clinical metadata, because as Nicole mentioned, endometriosis is a disease that has quite a lot of symptomatology that comes with it.
Selecting women likely to have endometriosis and then figuring out how we can bring biomarkers together to help secure that diagnosis. We did this in a discovery-based approach, so using samples drawn from our biobanks here at the Mass General Brigham. We sequenced the circulating microRNAs and performed a large-scale protein-based screen to look at potential biomarkers. We then went through the charts one by one of these individual study subjects, picked out patients with endometriosis that was surgically confirmed versus those who were initially shown to have absence of disease.
In total, used our machine learning technologies that we've developed for ovarian cancer, looked at more than 7,000 proteins, almost 3,000 microRNAs, and almost a dozen clinical variables that are predictive of endometriosis, and we're able to use our machine learning approach, cross-validate that in order to refine a model to distinguish well with endometriosis from those without endometriosis. Take the next slide. This is our approach so far. This is our initial take at this. This is combining a series of microRNAs and proteins and some clinical data.
For those of you familiar with the area under the curve here, this is quite highly significant, given the fact that the way that clinical practice works right now is that when a gynecology physician who's an expert in endometriosis takes a patient to the operating room for suspected endometriosis, they only find endometriosis 50% of the time. Really even in expert hands, the diagnosis of endometriosis is about a coin flip. Here we're looking at a test with, you know, an accuracy of about 85% for selecting those women who do have endometriosis from those who don't. I would just say this is highly encouraging for us to be able to refine this further, and we look forward to working with Aspira to do so. Next slide. Hand it back to Nicole.
Okay, thank you so much. Lot to be excited about when we look at the endometriosis portfolio, and then some of the things that both Ryan and Dr. Elias said were really important to keep in mind as we go through the market opportunity. The first one being that we worked hard to optimize the selected assay for our first generation test that we're going to launch later this year to optimize it both in terms of the commercial application, but to make sure that it was efficient and to, if possible, launch it in the lab that we already have and that we already use to perform our OvaSuite testing. Happily, we were able to achieve all of that.
At the same time, we're gonna continue to develop the second generation assay, working with our partners at Dana-Farber and the other institutions that are involved, so that we can continue to make sure that we're developing the most, the most useful tool for clinicians and for patients. Much to be excited about even as we move forward today for the rest of the year. What I wanted to close out before we open up for questions, talking a little bit about how all of this translates into the opportunity for Aspira. If you can go to the next slide. What we've done here is taken the full portfolio, both in terms of the OvaSuite portfolio and the endometriosis portfolio.
You know, the punchline is that we believe that we are looking at a total revenue potential, annual revenue potential for this portfolio of over $1 billion from things that are either already in the market or are near-term opportunities that will be launched this year. The two on the left, as we've talked about several times and should be familiar to you now, are currently commercially available OvaSuite tests, OvaWatch, the single-use test, and Ova1Plus, the surgical triage test. These numbers have been talked about previously.
We believe that there's more than 1 million, 1.2 to 1.5 million women a year who will be diagnosed with an adnexal mass. Those patients would all be appropriate for one of those two tests as part of their initial clinical pathway. When we move on to OvaWatch serial monitoring tests, we believe those patients could be appropriate for 2 to 3 additional tests as part of a serial monitoring program, which would drive additional revenue potential of $560 million-$660 million annually. You can see some of the assumptions we have here. We have not baked in a large improvement to AUP in this assumption.
Although we all feel very confident that we will continue to see that number grow as we execute on our reimbursement strategy. For purposes of this estimate, we even kept that flat, and you can see that we still have a very attractive addressable market here and revenue potential. Moving on to endo, it's a little challenging to say right now because we know that there are at least 6 million patients that or approximately 6 million American patients right now who are suspected to be suffering from endometriosis. We think there'll be an initial push to try to help those people, those women to understand their endometriosis profile and then additional women as we move forward. What Dr.
Elias said that was really compelling when you think about the opportunity and the revenue potential for EndoCheck is half of the women who go to surgery now for suspected endometriosis do not have it. You could see a scenario easily where those women who are currently going for laparoscopic surgery and turn out they don't have endometriosis are having an EndoCheck test first and never going to surgery because they don't have endometriosis. The women who do in fact have endometriosis and then would be appropriate for some treatment which may or may not include surgery. We believe that that is at least a $500 million opportunity. Again, we're looking at a 50% penetration across the patient populations.
We're assuming for that purposes, that it would be 1 million tests per woman per year for women with chronic pelvic pain for EndoCheck. Frankly, I think that's a very conservative estimate. All in, we believe that we're looking at a $1 billion in revenue opportunity from our products that we are going to have in the market by the end of this year. You can go to the next slide, please. I'll just wrap up by saying that, you know, our path forward has not changed. We are going to continue to focus on growth and execution, continue to grow Ova1Plus, which has experienced a 20%+ growth rate year-over-year, quarters-over-quarters.
We want to continue that growth trajectory. We're going to continue to focus on adoption and reimbursement for OvaWatch and of course, accelerate the development of our next two tests, OvaWatch and serial monitoring tests and EndoCheck this year as well. Do all of that while staying focused on prudent conservation of our resources and containment of costs in these very challenging times. That's all we have for prepared remarks. Hopefully at the beginning, I said that I thought you would all have reason to be optimistic about the prospects for a brighter future for gynecologic disease diagnosis in ovarian cancer and endometriosis. Hopefully, you found that to be the case.
We're going to open up for questions, and if there's anything that we didn't cover about the products we talked about today or anything else, the floor is open.
Great. Thank you, Nicole. Please hold for a brief moment while we pull for questions. Our first question comes from Ross Osborn, from Cantor Fitzgerald. Please go ahead, Ross.
Hi. Thanks for taking our questions. I really enjoyed the presentation today.
Thank you, Ross.
Maybe starting off with, Dr. Elias, if I pronounced your name correctly. You mentioned that miRNA or microRNA are detectable by all bodily fluids. Assuming the project makes it out of the research phase, could a future test be a stool or saliva-based test? I guess why or why not? If so, do you think patients would prefer these compared to a blood-based test?
It's a great question. We do know that microRNAs are detectable in saliva and stool, as well as urine, tears, sweat. It's possible that microRNAs that are diagnostic for endometriosis could translate over into another biological fluid like saliva. I think the difficult thing is that saliva has its own challenges as far as potential degradation of biomarkers. We have much more experience clinically with using blood-based biomarkers than saliva-based biomarkers for this context. I don't rule it out as a future technological development.
Okay, great. Thank you for that. One more, if I may. Maybe can we walk through the next steps for EndoCheck post the validation submission? I'm just trying to get the path to seeing reimbursement there. Just kind of curious what you think you'll need to demonstrate from a clinical data and an economic data perspective to receive reimbursement from both the public and private payers.
Ryan, do you want to start with that, or would you like me to start? I think you're still muted.
You can go ahead, Nicole.
Okay. All right. Ross, we're already focused on reimbursement for EndoCheck. It's going to be a very similar test in terms of how it's run and the way we develop the algorithm that we already have a lot of experience with Ova1Plus and OvaWatch. The clinical study that is ongoing, we believe is going to provide all of the information that we need to support both payer adoption and provider adoption.
It will be interesting to see the push from the consumer space, which is very different from potentially from our ovarian cancer portfolio because there's just so many women who are affected by endometriosis and who are out there already in these chat groups and working together with advocates for a solution that would help them to just get to diagnosis faster. I think we will actually see much more of a pull from patients for an endometriosis test like EndoCheck. I think that we may actually see a faster adoption from a provider perspective. We are already talking with payers about EndoCheck and reimbursement.
Yeah. I can add color into that for us. As you'll hear today, you know, endometriosis take a long time for accurate diagnosis. That put a extra burden on healthcare, both in term of patient and also the system as well, et cetera. When they go to referral for.
Ryan, you might have to repeat that. I'm sorry.
The cost for that surgical-.
Sorry, Ryan, we had a little bit of an internet glitch there for a minute. You got very robotic for a second. You wanna just go back and repeat that last piece again? Sorry.
Sure. I just mentioned to Ross that you're here today, that you know, about the difficulty of diagnosis of endometriosis and the waiting time for patient to get to that stage. It's a significant burden for both the patient themselves as well, the healthcare system. We don't see any reservation about having access into this assay when it's available. Having said that, additionally, right now, there's available medication that are proved to reduce endometriosis symptom. However, insurance require the accurate diagnosis before those medication been approved for coverage. We believe that having this EndoCheck assay available for both, accessible for patients as well as the healthcare provider gonna be a great effort, but also for reimbursement as well.
That's gonna be a plus for everyone because they believe that the insurance can see the reduction in the healthcare costs, as well as less frustrating for patients and provider alike in terms of having a accurate diagnosis and early.
Got it. Thank you for your insights.
Thanks for the questions, Ross. Our next question comes from Andrew Brackmann from William Blair. Please go ahead, Andrew.
Hi. good afternoon and thanks for all of the information today. I echo Ross in saying it was super helpful here. maybe to follow up on his line of questioning there, I may have missed it, but in the early data that you showed for the in-process test performance, can you just clarify if that was or was not a prospective study? If it was, can you just sort of reiterate sort of why this should be enough to sort of get payers on board? If it was not, just how do you sort of think about running a true sort of prospective study here to sort of really drive home the performance level? Thanks.
Thank you, Andrew. I assume that you asked about endometriosis EndoCheck assay.
That's right. Sorry, I should have clarified.
That's okay.
All right. That's a great question.
Why don't we go back up to 31 while you're talking and then 32 so we can reiterate, 'cause we did go through them kind of fast. Go ahead, Ryan.
Yeah. This assay, we are already developed and tested in the system, and we do have a large patient cohort for both retrospective biobank data but also external team, provider as, you know, additional cohort, if you will. We continue to collect patient sample through the clinical study to validate this and further product. We believe that this product actually meet the performance criteria, but also not only just that, but also feasible for putting into the clinical care due to the number of relevant biomarker and have the highest performance at this point.
On the next slide, if I'm not mistaken, Ryan, we plan on publishing data that would include both the retrospective data and the patient data from the clinical study, the ongoing clinical study.
That's correct.
Okay, that's clear. Thanks for that. Then maybe on OvaWatch, the serum monitoring test here, can you just sort of maybe talk about some of the considerations around sort of what goes into your assumption for, I think it was 2 to 3 serial tests per patient? I guess, how should we sort of think about the timeframe that you expect patients to get tested here? Is it once a quarter? Is it once a year? Any considerations there might be helpful. Thanks for the question.
Thank you, Andrew. That's a great question. You know, as you know, to be able to launch a product at the serial monitoring for adnexal mass, there's two questions come in mind. One of which is what the frequency of this OvaWatch is useful for clinician. Number two is when you have that subsequent testing, the chain of OvaWatch score, how does that mean clinically for the patient? We are working on that. I don't have a definitive right now until we get published paper, but I can show you that is markup of an example to see that we'd likely that to align with the current standard of care for the patient who currently not selected for surgery and been on sort of quote-unquote watch and waiting approach.
We will have modified a frequency when we launch in the test, and we also have provided exactly what the OvaWatch score change gonna mean for patients. Our clinical study continue to collect the patient and, according to protocol, and we believe that we have that patient data gonna be supported. We do have an abstract with our early preliminary data that been published in ASCO of this year and give you a sort of, a glimpse into what the outcome of that study, a final study looked like. We believe that we have that. At this point, we will say that, probably two to three times, as we can see that annually per patient, depend on how the clinician view it, depend on the patient. Also take into account the patient, presenting symptom at the time of visit to clinician.
Dr. Seay, did you wanna add anything to that? I mean, I know the serial monitoring test isn't out yet, but just sort of conceptually, what do you think?
Usually from the time of diagnosis of an adnexal mass to the time where we need to make a decision about any definitive treatment, the majority of time you're gonna do another ultrasound or do some type of radiologic screening within a 3-month window after the diagnosis of an ovarian lesion. Of course, that does depend on, as far as, you know, what size the adnexal mass was at the time of diagnosis. Do we have any of those concerning characteristics that need to be monitored a little bit closely? Of course, you know, 3 months is relative and, you know, if you're just looking in general, I wouldn't say that a test would be necessary any more frequently than a 3-month timeframe. Anywhere between 3-6 months, depending on the stability.
Thank you. That's what drove the assumption, Andrew, which is, you know, you know, maybe 2 or 3 draws for a patient before the doctor feels like they have enough information to sort of conclude if they're on the right path that Dr. Dunton showed us at the beginning, that you kind of have to decide with these indeterminate masses, a path. You know, there's an amount of time after where the doctor is still collecting that data. You know, we're making the assumption of 2 to 3. Ryan alluded to the fact that there's early data to support that based on the abstract that was published. That's sort of where we're standing right now. Hopefully, that answers the question.
It does. Thanks for the questions today.
Oh, thank you for being here. Do we have any other questions or any coming in online?
Yes. I'm gonna hand it off to Monique Kosse of LifeSci Advisors to moderate the written portion.
Hi, everyone. Yes, we do have a few questions from the audience here. The first one I'm gonna toss to management, but it might be a question for our physicians and clinicians here. Are you getting any pushback from doctors in using OvaWatch? If so, what's the criticism or pushback of the OvaWatch?
Dr. Phan just came back from ACOG, so maybe you wanna talk a little bit about what you heard then, maybe we can also ask for any clinician feedback from the doctors on the call.
Sure, I can share that, and I will leave it for three clinician here to add on to it. I was able to attend two major conference this year, the SGO, the Society of Gynecologic Oncology, and the most recently is as ACOG, American College of Obstetrics and Gynecology. There's significant interest in OvaWatch, particularly because many clinicians have been using OvaWatch, and I'm familiar with OvaWatch product. There's one unmet need that the clinician need the most. It's not about referral patient to surgery, about how to have a clinical tool that support the decision to wait for the patient. Either request that the patient themself or because that's not necessary at the time that the patient visits. There's no available tool except for a few imaging data.
As you hear from Dr. Dunton today, the imaging is indeterminate or sometimes is not concordant between the different provider interpretation. OvaWatch has garnered significant interest in those clinician. We have several requests, particularly because many of them have not heard OvaWatch before. It wasn't a surprise because we just launched it late last year. One more interesting part was that clinician were really pleased to hear that American Medical Association provide a specific PLA code for OvaWatch, indicating that, the test itself qualify medically for the patient care. I have seen so many discussion. We have a chance to provide that portfolio, in depth with OvaWatch, both in term of the usage, but also the clinical validation that we just published, and, looking forward to interact more with clinician across the country.
I haven't seen anything, but only the positive comment from OvaWatch, in addition to Ova1Plus. Dr. Seay, Dr. Dunton and Dr. Elias, feel free to comment on this one. Particularly Dr. Seay, you are the one who present the case that, you know, We have significant interest in the population in Georgia. That's why we have Dr. Seay who actually provide a couple KOL event for us, simply because he's very familiar with the portfolio, but also utilize the test and want to share that experience with the clinician across the country.
Absolutely. I'm in the southern portion of Atlanta where there is a lot of issues with access. We have several counties in the community near us that don't have any gynecologists, let alone GYN oncologists. Utilizing this battery of tests that we have here allows for patients not to go so far out of the way in order to see a specialist if it, if it's not indicated, especially if they have a benign lesion. Of course, Ova1Plus, you know, it's, I mean, there's a balance of its utility in regards to triaging those patients in regards to surgical management. I think OvaWatch is excellent in the sense that, you know, we haven't had a clinical tool like Dr. Phan said.
We did not have a clinical tool that corroborated with our wanting to watch and wait. The issue that may be, I guess, some pushback from some physicians is, you know, you have a patient that is perimenopausal, menopausal coming in with a sizable adnexal mass. The majority previously would have opted to go directly to a surgical management for the patient, irrespective of, you know, the patient's desire for surgery, whether or not the patient was an excellent surgical candidate, what have you. That was just kind of the mainstay. Now having an actual data point, an actual clinical tool that we can reference to say, "Hey, just because you're 56 years old with this adnexal mass, it does not necessarily equate to a surgical intervention for you.
In fact, we have this clinical tool that can watch and monitor, and if things change, then yes, we can start thinking about, you know, potential surgical intervention, but it's not always indicated. As Dr. Dunton said, a lot of surgeries that are performed by the gynecologic oncologists have been for benign disease. Allowing for there to be a clinical tool that's gonna allow for, you know, his caseload to be improved and for us to just watch and monitor those patients, I think the OvaSuite is excellent for that.
I think that, you know, it's pretty much what I've seen in my practice from gynecologists. If I said we can watch and wait on this case, previously with other biomarkers, in the past, we would generally repeat the biomarker to make sure it's stable. You know, my thing would be to do another ultrasound and a biomarker in 3 months. This is a better biomarker than what's been out there before. I look forward to the publication, and the data was very good. I think that that's what's gonna happen.
Thank you.
Great. Thanks. I'll move on to the next question here. It touches a little bit on the PLA code, Ryan, that you mentioned. Says you announced late last year that the AMA quickly assigned OvaWatch a unique PLA code that goes into effect in a few weeks or sometime in April. Can you walk through the impact this should have on coverage and reimbursement?
Sure. I can take on the first part, then I have Nicole to add on some color into reimbursement for that. When we prepared to launch in OvaWatch, when we writing the manuscript of publication of a multistandard clinical study, we also submitted the dossier to AMA to request for PLA code. PLA code is basically a CPT code for billings purposes, also qualify uniquely for particular test that we request, not like everything else. You can see that some of the well-known clinical assay available that have their own unique code, not just the CPT A-one-something number. AMA review our dossier, they review our clinical study and review our data with publication and approve this because it certified that the patient, the merit for this test will have that particular unique code.
This unique PLA codes is certified medically for the patient that should be qualified the physician order for coverage. Having said that, it will be add on additional layer, a qualification for payer to review and approve the for the coverage. Not many of the tests available out there have a unique PLA code like we have with OvaWatch. We believe this gonna be a significant impact in our reimbursement. In fact, one of our largest, national payer, one, understand that our publication with the PLA code already approved the coverage, and Nicole can add on some information.
Yeah, I mean, that was a great summary, Ryan. You know, I think it adds a layer of credibility behind the test that AMA assigned a unique PLA code. I think it does inherently recognize the uniqueness of this tool and the fact that there is nothing like what we have launched available for this clinical use. You know, it's obviously extremely helpful. It did go into effect on April 1st. What it typically means from a reimbursement perspective is when you launch something new and coverage is still sort of, you know, out there or contracting is still sort of in process, you know, you're more likely to get paid for a test that is run through its own unique PLA code.
There is generally less requests for medical records or medical necessity, and it sort of takes away the answer of it being an experimental test, which is usually a challenge to get over when you have a new test in the market. You know, while I don't really wanna go into a lot of details about specific collection since it went into effect, I will say that the benefits that we expected appear to be making themselves known, let's say. We do think that it's going to be incredibly beneficial to us as we move forward.
Okay, great. One more question here, and it relates to volumes. Your 1Q23 volumes were up 29%. Surprisingly, Ova1Plus was the big driver, as you didn't see much impact from your newly launched OvaWatch. As OvaWatch starts to accelerate, do you expect much cannibalization of Ova1Plus?
No, we do not expect cannibalization. When we created the requisition form for the test, we did so in a way that we made sure doctors truly understood and healthcare providers truly understood when they were ordering the test, the benefit or the intended use of each, so that there couldn't be a lot of confusion between which one to order. It's pretty clear, based on the situation, which test, you ought to order. They are not, they are totally different tests with completely unique algorithms and completely different science. You know, we have not seen any reason to be concerned with that. I'd be happy to hear from any of the clinicians who wanna comment on that as well.
If this gets to be the day where I get three doctors to say I did a perfect job, I'll take it. Go ahead, Doctor.
No, no, you actually did do a perfect job.
Oh, thank you.
I think the biggest thing is, of course, when the patient comes into the office and they show signs and symptoms of the need for surgical intervention, I think it's very clear that we're gonna pick Ova1Plus as the biomarker screening to perform for that patient. I don't think that there would be a lot of confusion in regards to the implementation of OvaWatch. Those are definitely gonna be those patients who have, you know, very indolent symptoms. They have some, you know, mild amount of suspicion in regards to the adnexal mass, but they're not a patient that's gonna definitively need surgery within the next 36 months for an adnexal mass. I think as a general clinician and general gynecologist, those patients are very distinct.
I think the utilization of the 2 biomarker screenings is also going to be very distinct and physicians won't get confused.
I concur. Well said.
Great.
Excellent. I have no further questions or written questions that have come in, so I turn it back over to you, Nicole, for any closing remarks.
Great. Well, we covered a lot of ground today. There was a lot of information. I wanna thank our clinicians for joining us, and I especially want to thank Dr. Elias for the partnership. It's been a wonderful relationship for Aspira, and we appreciate having the opportunity to continue to work with you on expanding the portfolio. We'll make the materials available to anyone who wants to take a deeper dive into the data. We really do appreciate you taking the time to join us today. We're incredibly proud of what we've accomplished, but the second half of the year is critically important, and we're gonna keep, we're gonna keep our shoulder in it and keep moving forward. Thanks so much for your time.
Thank you.