Good afternoon and welcome to Castle Biosciences ' DecisionDx-SCC Launch Conference Call. As a reminder, today's call is being recorded. We will begin today's call with opening remarks and introductions, followed by a question-and-answer session. I would like to turn the call over to Frank Stokes, Chief Financial Officer. Please go ahead.
Thank you, Operator. Good afternoon, everyone. Welcome to Castle Biosciences' DecisionDx-SCC Launch Conference Call. As with most presentations, the following discussion contains forward-looking statements, and our actual results may differ materially from those discussed here. Additional information concerning factors that could cause such a difference can be found in the disclaimer slide included in the presentation and the company's quarterly report on Form 10-Q for the quarter ended June 30, 2020, and the annual report on Form 10-K for the year ended December 31, 2019. I'll now direct you to our agenda today. We appreciate your interest, and we will go through several presentations and allow for questions at the end. In addition to Derek and me on the call today, we have the additional Castle Biosciences attendees listed on the slide here. They're available for questions if needed, but won't have speaking parts during our presentation.
We're excited today to be joined by Dr. Ashley Wysong from the University of Nebraska Medical Center in Omaha. Dr. Wysong is the founding chair and William W. Bruce, M.D., distinguished chair of the University of Nebraska Medical Center Department of Dermatology. She earned her medical degree at the Duke University School of Medicine, where she was also valedictorian. Dr. Wysong completed her MS in epidemiology and residency in dermatology at Stanford University, where she also served as chief resident. Her fellowship in procedural dermatology and Mohs micrographic surgery was completed at Scripps Clinic under the direction of Dr. Hugh Greenway in Mohs surgery, Dr. Victor Ross in laser and cosmetic dermatology, and Dr. Leland Houseman in veins. I'll now direct you to the next page of the deck, and I'll turn it over to Derek Maetzold, Castle's President and CEO.
Thank you, Frank. Good afternoon, everyone. Before we get started here, I think it's worth taking a moment or two to recognize the fact that Castle is now moving into its third chapter of hopefully a multiple-chapter life, and it's appropriate to recognize those individuals that have gotten us to where we are today. Chapter One, when we launched the company in the latter part of 2008, we were focused on providing solutions, diagnostic test products to meet unmet medical needs for patients diagnosed with rare cancers. DecisionDx-UM for patients diagnosed with UV melanoma is the legacy of that initial focus. Chapter two began with the initiation of our own internal R&D program. The first program that we worked on is what we now call DecisionDx-Melanoma for use in early-stage cutaneous melanoma.
Chapter Three, in my view, represents our move from offering a single product or a single solution to serve patients diagnosed with skin cancer to having the opportunity by year-end to serve three areas of unmet clinical need: that of patients with early-stage cutaneous melanoma with our DecisionDx-Melanoma test; early-stage but high-risk cutaneous squamous cell carcinoma with the DecisionDx test, SCC, which is the focus of our discussion today; and a third test for use in patients who were biopsied to rule out melanoma, but in which the diagnosis remained suspicious or difficult. As you know, we have completed validation of our Suspicious Pigmented Lesion Test, and we are on track and expected to be commercially available in the fourth quarter of 2020. Now, how did we get here? I think there are three groups that we should be recognizing.
First and foremost are the patients who agreed to participate in our clinical research programs. Without their tumor specimens and their associated clinical outcomes data, we could not perform the work necessary to get us from an idea to a clinically validated test. Second is our collaborators, like Dr. Wysong, who you'll meet in a few minutes. In the case of our DecisionDx-SCC test, we now have over 92 collaborating centers who have contributed samples and data on over 1,400 patients. The data that Dr. Wysong will be walking through today is focused on the 420-patient cohort that were part of the clinical validation study.
The third group that needs to be recognized and thanked are our employees, from our strategic individuals who framed out the clinical need to our R&D folks who thought through the study protocol approach, including gene selection and analysis approach, to our clinical research operations group who contacted, contracted, and successfully worked with our 92 collaborating centers, to our laboratory group, including IT, who developed assay procedures during the discovery phase of the program that were able to move and translate over into our clinically validated test. Of course, to our commercial and reimbursement teams who pulled together what we are seeing as a successful introduction of a much-needed test, one that will dramatically improve the accuracy of the likelihood that an individual patient diagnosed with localized but high-risk SCC will or will not metastasize.
To these three groups, I personally thank you on behalf of the patients that we will serve from this day forward. We would not be here today without your decision to support the development of our SCC test. I thank all of you, our patients, our collaborating centers, and our employees. Some of you may not be totally familiar with the Castle story. Let me spend a couple of minutes on this slide here about who we are, what we do, and where DecisionDx-SCC fits into the Castle equation. First and foremost, we are a diagnostics company that focuses on developing solutions for unmet needs in patients diagnosed with dermatologic cancers. Thus, we innovate.
Once we identify a test that adds substantial value to clinical decision-making, we then commit to investing year after year in clinical research to confirm the accuracy of our tests, as well as to build out evidence on how to get the best value out of our tests. How do clinicians and patients best get value out of our tests? Thus, we develop evidence. In fact, between January 2015 and August 2020, there were over 26 peer-reviewed publications that supported the use of our DecisionDx-Melanoma test, and there are more to come. That's going to be the hurdle we set for ourselves for DecisionDx-SCC. We believe that this commitment to evidence translates into appropriate adoption by our clinical customers and reimbursement by Medicare and commercial payers.
We believe that the output of focusing on these first two blocks is what has put us into such a strong financial position. Next slide. As a reminder of our position today, I wanted to spend one minute here on our 2Q 2020 financials. This represented, obviously, second quarter performance and performance through 2Q, although you could argue it was the first quarter of the COVID pandemic. As a reminder, we achieved $12.7 million in revenue in 2Q 2020, which represented growth over 2Q 2019. We also saw continued lift in gross margin that we expected, which came in at 83%, and we ended 2Q 2020 in a very strong cash position with cash and cash equivalents of nearly $180 million and adjusted in-period operating cash flow of $3.3 million.
Our team has executed extremely well over the last couple of years, from the lead-up to our IPO in July 2019 through to today. I'll just highlight for you that we set out to achieve certain milestones in early 2020. We have already hit two of them and are on track to hit the rest of them, not only hit them on time, but early. As I alluded to on the prior slides, I expect us to turn the page at the end of this year, December 31, 2020, having moved from a single dermatological product, DecisionDx-Melanoma, to having three clinically actionable proprietary gene expression profile tests available for clinical use. This is a great way to end a great year. This slide turns the columns on the prior page into rows and adds some perspective. I'm only going to comment on the last two rows.
We currently have two primary customer groups for our DecisionDx-Melanoma tests: medical dermatologists, including Mohs surgeons like Dr. Wysong, and surgeons, some general, some surgical oncologists, some plastic surgeons who perform sentinel lymph node biopsy surgical procedures and wide local excisions on patients with early-stage melanoma. The dermatology audience, as you may recall from earlier calls, is responsible for about 80% of our test orders. We do call on two additional groups of physicians: dermatopathologists so that they and their teams understand why their referring dermatologist, our joint customer, is ordering our DecisionDx-Melanoma test, and medical oncologists to locate those oncologists who will manage a DecisionDx-Melanoma high-risk patient as a high-risk patient.
I mention these points because we will be in a unique position in that the primary target for our DecisionDx-SCC test is that same medical dermatologist, including Mohs surgeons who we call on and work with today. In the last year, over 4,200 of them have reviewed, considered, and acted upon the value of DecisionDx-Melanoma test, what that value can bring to their patients in the management of their cutaneous melanoma disease. We expect that many of these same clinicians will favorably review our DecisionDx-SCC test for their patients who are diagnosed with one or more high-risk factors. The call point for our test for suspicious pigmented lesions also overlaps well with our current call base. Specifically, we received tissue specimens for clinical testing from over 1,900 dermatopathologists in the last 12 months.
Again, our initial launch targets will be these same dermatopathologists with whom we have developed and had relationships over the last several years. A couple of brief comments on what the DecisionDx-SCC is and the workflow. Our test has been validated for use in a patient who has been diagnosed with invasive cutaneous squamous cell carcinoma or squamous cell carcinoma of the skin and one or more risk factors. As you may recall, there are well over 1 million invasive SCCs diagnosed per year, but we currently estimate that only 20% or 200,000 patients present with one or more risk factors on an annual basis. This is our target patient population. Once diagnosed, a clinician can order our test, DecisionDx-SCC, via fax or uploading an order form into our secure HIPAA-compliant portal. From there, our client services team in Phoenix takes over.
They will reach out to the respective dermatopathology lab where the tissue specimen is located or resides and request sections from that tumor specimen. These are then received in our laboratory, and we begin the RNA extraction and purification process to prepare for the expression of 40 genes, 34 that are discriminatory between a low and high risk for metastasis and fixed control genes. The output of this qPCR step, the expression levels of those 40 genes, are then fed into our proprietary trade secret algorithm, and an output is generated that we will report as Class 1, Class 2A, or Class 2B, with Class 1 representing the lowest risk of metastasis, Class 2A a moderate risk, and Class 2B a high risk of metastasis.
Of note is the fact that while these were all patients with one or more risk factors, which put the patients in the high-risk category according to NCCN guidelines, approximately 50% of the time, these patients had a Class 1 or low-risk test score, meaning that they have a biologically low risk of metastasis despite having high-risk pathology features. This percent is obviously significant as it can allow a patient and their clinician to discuss the option of watching and waiting as opposed to proceeding forward with interventions meant for patients with true high-risk SCC. On a final note, I think it's important to emphasize that while the order form for DecisionDx-SCC will naturally look a bit different from the order form for DecisionDx-Melanoma test, all current customers will see this process as identical to that existing test.
The same goes for the dermatopathologist laboratories that we'll be working with to secure tissues in a rapid fashion. The same goes for our internal laboratory processes, from accessioning to wet lab processes and reporting. In other words, low-risk launch, low risk for confusion, high likelihood of satisfied customers. How do we get to where we are? At the discovery phase, we employ several principles as a company. The first principle starts with a core belief that we should only work in a specimen type that will fit right into the current workup of a patient. Thus, while it may be scientifically pure to start with fresh frozen specimens, we believe that whatever we discover must work, in this case, in FFPE tissue or formalin-fixed and parapigmented tissue, as that is how all SCC biopsies are preserved.
Our starting material throughout the entire discovery to develop the validation process or program has been to limit our work on FFPE tissue, the kind of tissue we'll be testing clinically. We use two approaches to identify candidate genes for DecisionDx-SCC development: a targeted approach and a global approach that employ deep learning. Some of you may commonly call this AI. From these efforts, we identified 140 gene candidates and then moved to the development stage. Our development stage involves selecting a training cohort of 122 samples with known long-term outcomes, then starting again with deep learning. With neural networks, we were able to reduce the genes of interest to 34 and finalize and lock a particular algorithm for independent validation. Dr. Wysong will walk you through the validation cohort data.
Over the last 12 months, we've been able to successfully complete a number of studies and have them published. As you see in this slide here, we have generated peer-reviewed publications that support both the clinical validation of the assay and the intended clinical use of the assay in the last 12 months. With that, I'll turn it over to Dr. Wysong, introduce her as the Chair of the Department of Dermatology at the University of Nebraska Medical Center in Omaha, Nebraska. Dr. Wysong?
Thank you so much, Derek, and excited to be talking to you guys today about our newly developed test for cutaneous squamous cell carcinoma. As you all have heard, cutaneous squamous cell carcinoma is one of the most common cancers that we treat in the United States and really globally. Approximately 1 million patients are diagnosed with squamous cell carcinoma each year in the United States. As Derek had mentioned, approximately one-fifth of those or 200,000 patients are identified as high risk based on multiple different factors. We take those risk factors then and look at our national guidelines to ultimately develop treatment recommendations based on these risk factors.
What we've learned, and by treating these every single day, I recognize the downfall that traditional clinical pathologic-based risk factor systems suffer from what we think of as low positive predictive value, meaning that many more patients are actually classified as high risk than they are, and then those that actually go on to develop metastatic disease. What this means is we often can lead to overtreatment for these types of patients or even undertreatment for a substantial number of patients that are identified as low risk but really are at higher risk for metastasis. Moving on to slide 18, this is one of my favorite slides to really look at when we try to assess the overall impact of cutaneous squamous cell carcinoma.
What we're seeing here in blue is a typical cancer, the cancer numbers that are maintained by the SEER National Cancer Registry. When you actually stack up squamous cell carcinoma over the top five cancers that are measured by the SEER database, which includes breast cancer, lung cancer, prostate cancer, colon cancer, and melanoma, we see that there are more cutaneous squamous cell carcinomas than all the rest of those combined, which is pretty impressive when you think about it across the board. Moving on to slide 19, I want to take you through what the typical patient journey looks like for a patient that gets a new diagnosis of squamous cell carcinoma and really where DecisionDx-SCC will play a role.
The typical patient, as Derek had mentioned, is seen for a suspicious lesion on the skin, often by the patient themselves or honestly a spouse or family member or potentially when going in to see a primary care provider. The patient is then typically referred to a dermatologist who performs the skin exam. As mentioned previously, around 80% of those patients are seen primarily by a dermatologist. The patient undergoes a typical history and physical examination. When we're concerned about squamous cell carcinoma, we will often perform a regional lymph node examination. The true diagnostic component that comes in will be the skin biopsy that happens. When the skin biopsy comes back with the diagnosis of squamous cell carcinoma, the typical dermatopathologist will look for some "risk factors" that we see in squamous cell carcinoma, which we're going to talk about.
This is where it will really trigger a board-certified dermatologist or a surgeon, primary care physician, or a Mohs surgeon to really start thinking about DecisionDx and what we can do now that we know we have a diagnosis of squamous cell carcinoma that is considered high risk with one or more risk factors. Moving on to slide 20. Honestly, like all cancers, SCC management plans are guided by the risk of metastasis and ultimately utilizing tumor staging. Traditional tumor staging is what we call the TNM model or tumor factors, nodal, and then metastatic disease.
Now, as we've kind of discussed previously, the reliance really on the clinical or pathologic risk factors, whether or not you incorporate them into staging, can be really challenging for patients who have high risk factors but do very, very well because we can unfortunately overstage those patients and treat them when they may not need a more complicated treatment. It really makes it difficult to personalize or to really target or trigger a patient's management plan based on a risk factor alone. Moving on to really the clinical problem. I think as many of you know, and we have talked previously about the DecisionDx-Melanoma prognostic study, melanoma has been traditionally viewed as the most deadly form of skin cancer. This is absolutely true relative to the overall incidence of melanoma.
I mentioned we treat about a million squamous cell carcinomas a year in the U.S., and we treat around 80,000 melanomas. Now, as the incidence of squamous cell continues to grow rapidly with the aging baby boomer population and in general, as individuals are living longer, we see that the number of SCC patients that are actually dying from squamous cell carcinoma is now surpassing that of melanoma. This really concerns myself as well as all of us in the field when we're thinking about the management of squamous cell carcinoma because it's now obviously a very significant clinical issue. This is really where DecisionDx-SCC comes in. It obviously now has gone through discovery phase, development phase, and now validation to predict the metastatic risk for an individual SCC patient that has one or more risk factors. This is really important.
Our studies overall have found that the DecisionDx-SCC gene expression profiling test is truly the most powerful predictor both in univariate and multivariate analyses, which we are going to go through. Ultimately, we know that incorporating DecisionDx-SCC and tumor biology along with our clinical and pathologic risk factors really provides a superior classification to utilizing either one of these alone. One of the reasons that I have been really excited about DecisionDx-SCC is that this truly is a development program that was initiated based upon the recommendation of clinicians. In fact, a little sidebar, I remember sitting in a melanoma meeting in San Diego several years back and saying to one of the Castle reps, "Man, this melanoma test is amazing.
We really need to look at developing this in squamous cell carcinoma." The reason why is because given the poor predictive value of the clinical and pathologic factors alone, we knew very early on that if we could develop a similar test for high-risk SCC like was developed for melanoma, it really has the potential for a major impact in our skin cancer population. Moving on to slide 23, this really goes over the typical risk factors that we see in squamous cell carcinoma. DecisionDx's intended use is for patients that have one or more of these risk factors listed on the slide. As mentioned by Derek, DecisionDx-SCC is a 40-gene expression profiling test that actually uses a patient's individual tumor biology to go on and predict that specific patient's individual risk of squamous cell carcinoma metastasis.
We know that squamous cell carcinoma metastasis is the biggest predictor for death in these patients. This is extremely important to be able to identify. Ultimately, the test result, as mentioned by Derek, stratifies patients into a Class 1A, Class 2A, or Class 2B risk category and ultimately is meant to be used as a prognostic method for determining the risk of metastasis and ultimately management in association with the other risk factors. Now, four peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk. Ultimately, integrating DecisionDx-SCC with current prognostic methods and clinical risk factors actually adds positive predictive value to clinician decisions regarding staging and management, which is really important. Moving on to slide 24, this actually highlights our overall validation study. Derek mentioned the discovery and development phases.
This is the independently performed validation study. It involved 420 participants over 33 centers. All patients met NCCN criteria for being high risk in squamous cell carcinoma. 65% of the tumors were on the head and neck, and a quarter of participants were immunosuppressed, which is what we're seeing in a lot of our patient populations, particularly as the number of organ transplants and other immunosuppressive medications are going up. In our cohort overall, we saw a 15% metastasis rate. This is ultimately what we want to see when we're developing a prognostic test. We want to almost oversample for a higher rate of metastasis so we can ultimately develop a prognostic test and validate its use in this study. The overall median time to metastasis for this patient population was 0.9 years, with 95% of them metastasizing by 2.7 years.
Moving on to slide number 25, which is really the money slide when we're looking at the validation study. This is a Kaplan-Meier analysis for metastasis-free survival for the validation study in the 420 patients with high-risk SCC. In the validation study, metastasis was defined as a regional or distant metastatic event. Importantly, local recurrence of the tumor was actually excluded from this definition. We think that local recurrence can have other factors involved rather than just tumor biology alone, including the way that the patient was treated. Really, as you can see here on the Kaplan-Meier curve, there is a strong separation between Class 1, 2A, and 2B results. As a reminder, the overall risk of metastasis in the patient cohort was 50%.
As you can see here, patients with a Class 1 result have less than half the metastatic risk seen in the overall study population, half, which is really important to identify these patients who may otherwise be overtreated based on having one high-risk factor. When you look at Class 2A, these patients actually behave similarly to those with most adverse traditional clinical pathologic risk factors, such as deep invasion or poor differentiation. The 2A is similar to the strongest clinical pathologic risk factors. It is about where they are performing from a biologic standpoint. Now, Class 2B, in this case, these patients have an over 50% risk of metastasis. It is really identifying this most worrisome group. The other really important component is this has the highest positive predictive value, higher than anything that we have seen before.
Overall, what's kind of important to know with this large validation study of high-risk SCC is that half of the patients will end up being Class 1, which is the low biologic risk. Approximately 40%, less than half, will end up as Class 2A, that moderate biologic risk. About 1 in 18 will have a Class 2B result with that high risk of over 50% metastasis. Moving on to slide 26, when we actually look at univariate and multivariate analyses involving Class 2A and Class 2B gene expression profiling results, we see that overall, Class 2A and Class 2B perform beautifully in univariate and multivariate analyses compared to other common high-risk factors that we think about in squamous cell carcinoma.
Kind of as a baseline, an SCC with deep invasion is about 2.1 times more likely to metastasize than an SCC that does not have deep invasion. When you add a Class 2A result to that, it really shifts to more like 4.8 times more likely to metastasize. If you get a Class 2B result in a patient with one high-risk factor, it's going to shift that to 14.5 times more likely to metastasize. You can really see the power of that gene expression profiling and the tumor biology being added to classic clinical pathologic risk factors. Moving on to slide 27, how do we envision using DecisionDx-SCC? Ultimately, again, we have a group of patients, SCC patients with one or more risk factors, which is about 200,000 patients a year.
We utilize DecisionDx-SCC and add that to our traditional prognostic risk factors to ultimately come up with a low, moderate, and high-intensity treatment plan. It is really going to, I think, help us with developing follow-up and surveillance plans. For example, someone with a high-intensity or a Class 2B result, in addition to surgery, which is a baseline for pretty much all cutaneous squamous cell carcinomas that are operable, these patients may need nodal imaging and staging in addition to a multidisciplinary approach utilizing radiation oncology, medical oncology, and even surgical oncology, depending on the patient and the individual tumor.
Surveillance plans also might be increased significantly, whereas a typical low-risk squamous cell carcinoma might be seen every six months, a patient with a high-intensity or Class 2B result could be seen as frequently as 4-12 times a year, meaning monthly, for a period of up to three years. They will often undergo baseline CT or nodal examinations and may do so typically every three to six months for two years. This is a drastic difference in treatment plan as well as surveillance, depending on our DecisionDx-SCC tumor biology result. Moving on to slide 28, I honestly am just so excited about the integration of DecisionDx-SCC into the clinical care of my patients.
I have to tell you, I called the company immediately when I heard it was being released and said, "I need the order form." This is the reason why, because when you really think about the way that we treat cutaneous squamous cell carcinoma and really all cancers in the United States today, it's a combination of the patient factors, the things that the patients were born with, their age, their underlying immunosuppression, other things that might put them at higher risk for developing squamous cell carcinoma. We take our typical clinical and pathologic tumor characteristics that are used commonly in the staging systems we use today. The real power in my mind comes with that personalized precision medicine approach when we're able to integrate tumor biology into our daily decision-making.
At this point, I'll go ahead and pass it back to Derek for a summary of today's discussion.
Thank you, Dr. Wysong. I'm on slide 30. To preempt a couple of expected questions, which I think will be, "How does launch look so far?" which you may not answer, by the way, I thought it was worth sharing with you a little bit about what we did do preparing up through August 31 st of 2020. First, I again have nothing but praise for our employee group, our consulting groups, our industry partners, and pulling off a well-coordinated training and launch preparation. We were far enough ahead of the game in training earlier this spring that we were actually able to successfully pivot and use some of the COVID-related stay-at-home time to accelerate disease state training in the second quarter. That made for a much more efficient training session at last week's virtual national sales meeting where we completed training.
We were also able to successfully train a number of speakers who will help launch this program from a peer-to-peer opportunity beginning Monday, August 31st, going forward when it was available. Finally, of course, we were able to develop and complete, I think, a very nice orchestrated effort from both website activity, slide decks for speakers and our sales force and our medical science liaison group to use, and an order form and a report form that we believe will be self-explanatory to dermatologists and Mohs surgeons who will be explaining the results of our tests and the implications on their patient care going forward. Congratulations on a really, really perfectly ineffort from a team standpoint.
In closing, the Castle team together with our patients and collaborators were successful in efficiently discovering and validating our DecisionDx-SCC test for use in patients diagnosed with invasive squamous cell carcinoma of the skin and one or more high-risk factors. We are launching into a market that we believe contains 200,000+ patients per year. Assuming achievement of an average solid tumor reimbursement level of $4,200 represents a U.S. TAM of approximately $820 million. We have already developed and published evidence for studies in the last 12 months. We are well on our way to building out additional evidence. Finally, we are able to launch this test to the very same clinicians who adopted our DecisionDx-Melanoma test.
Our hope will be that these same customers will already be oriented towards knowing the value of biology of their patient's tumor through a test provided by Castle Biosciences, with the end result being that patients will have more accurate, more appropriate treatment plans. Operator, we'll now take questions.
Thank you. To ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question will come from the line of Sung Ji Nam from BTIG. You may begin.
Hi. Thanks for taking the questions. Congratulations on the launch. Just a couple of clarification questions for Dr. Wysong and then a follow-up. Dr. Wysong, I was curious about how this test might be used in conjunction with the existing AJCC and Brigham staging systems, if they will be used concurrently. I'm just kind of curious as to how much do the clinicians currently rely on the AJCC and Brigham systems, given the limitations there?
That is a fantastic question. Actually, if you read our manuscript, we did multivariate analyses comparing the Castle Class 2A and 2B results against both AJCC and Brigham and Women's staging. The DecisionDx-SCC test outperformed both Brigham and Women's as well as AJCC and added an increase in positive predictive value overall, which is really, really exciting. That being said, I don't think in any way, shape, or form that gene expression profiling is meant to replace staging. It's really meant to be in partnership and an adjuvant to clinical staging. Really, clinical staging, again, is reliant on pathologic and clinical risk factors.
I think we've known as physician scientists for quite some time that the missing piece there is the tumor biology, just based on anecdotally what we see in our patients, but also just in terms of what makes sense for metastatic risk. Overall, we're very excited to be able to integrate the gene expression profiling tumor biology data with what we know about our current AJCC and Brigham and Women's staging.
Great. That's very helpful. Just another clarification question. In terms of the 20% of the squamous cell carcinoma patients being classified as high-risk, how robust is that, the criteria used, the NCCN and others? I'm just kind of curious if there is a significant cohort among the other 80% that end up metastasizing as well.
Yeah. That's a great question. There are cases, obviously, we know of patients that don't have one of the NCCN, AJCC, or Brigham and Women's high-risk features but do go on to metastasize. Honestly, that's a study that I would, that's a group that I would love to be able to study further. That being said, 20% of a million, that's a pretty high number. We also don't want to get into the situation where we're overtreating patients that were otherwise low-risk. I think there is a subset of patients, I would say probably less than 5% overall in that 80% group that might go on to metastasize.
What we find, at least clinically, is those are often patients that have multiply recurrent disease based on persistent tumor that was left behind or patients that might have underlying immunosuppression or other patient-specific risk factors that could be impacting that as well. Tumor biology would be extremely helpful in those types of patients. That is a group that we would love to study further and figure out how to integrate this kind of testing.
Great. Lastly from me, this is not related to the product launch, but kind of curious, in light of the pandemic, I was kind of curious to hear your observations in terms of patient flow during the pandemic, maybe at the start of the pandemic compared to during the summer months. As you look out into the fall, do you anticipate, I'm just kind of curious as to kind of what kind of trends you're seeing in terms of patient flow. There are concerns about patients delaying their diagnosis and treatment in oncology in general. Kind of curious what your thoughts are there.
Yeah. Great question. Absolutely. Really through the months of March and April across the country, obviously, we saw a delay of care with people appropriately being unwilling to come out during the pandemic and the high-risk times. In addition, what were considered elective surgeries were postponed during that time. We were still treating high-risk squamous cell patients and melanoma patients, what we would call medically necessary patients during that time. Nonetheless, I think particularly through the months of May, June, July, we saw a pretty significant increase in volume of that backlog. I would say, at least throughout most of what we're seeing in the Midwest and what I'm hearing from most of my colleagues across the rest of the country is most of us are back to about 90% of pre-COVID volume to 110%.
We're a little over 100% of pre-COVID volume because we're still just a little bit backlogged. I think what we've learned, and I will tell you, the University of Nebraska is kind of ground central for emerging and infectious diseases. We have really been on the front lines of this. As you may remember from the footage, we received the Diamond Princess cruise, the very first COVID patients here in the U.S. We have really been involved with this from every level. What we're seeing is we've gotten a lot better at learning how to safely treat our patients, and particularly when it comes to skin cancer patients. The vast majority of those are done in the outpatient setting under local anesthesia and very safely in the time of COVID.
I really don't see there being major shifts over the next 12 to 18 months in terms of delay of care, particularly when it comes to kind of more aggressive and high-risk squamous cell carcinoma. I did just want to also follow up and answer your question. I pulled up the exact numbers so you can have it. We did a multivariate Cox regression analysis of risk for metastasis utilizing the 40 GEP validation cases and multivariate regression with AJCC as well as Brigham and Women's T stage. When you put AJCC8 into the model with gene expression profiling, what we found is that the high-risk AJCC8, which is considered to be T3 or T4 tumors, had a hazard ratio of 2.68 for developing metastasis compared to the Class 2B result, which had a 9.55 hazard ratio for metastasis.
Very similar results that we saw when putting that multivariate model with Brigham and Women's staging, which looking at high-risk BWH staging, which would be considered T2b and T3 tumors, T2b and T3 tumors had a hazard ratio of 2.03 for metastasis compared to 8.72 for a Class 2B DecisionDx-SCC result. Really, we're finding that that increased ability to predict metastasis utilizing tumor biology and the DecisionDx test.
Great. Thank you so much.
Mm-hmm.
Thank you. Our next question will come from the line of Puneet Souda from SVB Leerink. You may begin.
Yeah. Hi, Derek and Dr. Wysong. Thanks. First, let me cover a few questions, Derek, with you and then with Dr. Wysong. Just on the initial centers, how are you targeting? Are you specifically looking at certain Mohs surgery academic centers first and then expanding broadly? Just walk us through how are you thinking geographically and the number of salespeople that are getting deployed in those geographies?
Yeah. The input to our targeting efforts was a combination of existing customers and call points with our DecisionDx-Melanoma test. We were able to secure some third-party billing data that was able to identify relative volume. The physicians who use that billing software system for the diagnosis of SCC, we overlaid that against our known data sets. We also looked at some Medicare claims, largely against cutaneous melanoma because SCC is a little more dicier in some of the data we pick up out of CMS and overlaid that. I think the field left the virtual national sales meeting last Friday, I think, with a solid list of people who we have data on.
We're undoubtedly missing some out there, but they're going to go out or they have been going out beginning Monday in a targeted fashion to, of course, first priority is to regain the sort of pre-COVID growth of a DecisionDx-Melanoma test and then introduce the DecisionDx-SCC test. I think it's natural that one goes to where clinicians have already reviewed cutaneous melanoma and thought about the value of incorporating tumor biology, as Dr. Wysong said, into what they already have and complement to help them make a more accurate and more informed decision.
My belief is that the early sort of adopters, if you want to call that, would be those who have already thought intellectually through and believe that adding the tumor biology data afforded to them through our DecisionDx-Melanoma test, that individual should be already oriented towards the value of getting more information to make a better decision in squamous cell.
Okay. That's helpful. If I could sort of if you could give us a view about the potential adoption and trajectory here for the assay, should we assume that this is going to be similar to cutaneous melanoma? Obviously, those were different time points. And your experience with gene expression profiling and adoption and recognition of Castle in dermatology practices was different back in the day. Considering a different time point today, how should we think about adoption of the assay over the next couple of months into 2021?
Yeah. One, I want to give you no quantitative data you'll hold until later. Second, of course, is that when we completed our initial validation for our DecisionDx-Melanoma test, I think we had three people who we would call sales representatives in the company, and now we have 32. Far different. Of course, nobody knew who the name was or what even a gene expression profile test meant in dermatology. We had no name recognition, no targeting data, and no awareness of kind of what goes on in breast cancer for the average kind of dermatologist out there. Dr. Wysong probably was one of the first doors we actually knocked into in San Diego there so many years ago. Anyways, I anticipate that we will try and hold ourselves to reporting reports out the door as opposed to orders in.
That would mean just having a test available here at the 31st of August, we'd be able to report some tests that are ordered in the next two weeks before the end of September, but most of them will end up being fourth-quarter reports. I'm not sure if we'll adjust on a one-off basis for the third quarter, but my personal perception is that without knowing the impact of COVID on openness to a longer educational discussion with our field forces, is it going to take us all the way through the end of the year to really have most current customers be aware of the test, or is it going to be compressed? I don't have an answer for that.
Our internal expectation here is to really kind of watch the sort of remainder of the year as a single unit as opposed to third and fourth quarter. I think by the time we close out the fourth quarter, we'll have a good early indication of what we've sort of seen in terms of numbers of doctors evaluating our test, i.e., ordering it once. I think the most important point from there is probably looking at our second quarter performance against the fourth quarter, and that would at least show us some velocity growth numbers that should help us project what we look like in 2022 and 2023. That's my current thinking about the data. I know I avoided your question as best as I could here, but I really don't have a handle on what we'll be seeing.
I think that's dependent upon really having time in front of clinicians like Dr. Wysong and working through, "Here's what we saw as an issue clinically. This is not the 80% of the people out there. It's the 20%. Here's the data that we developed, and here's how we believe your peers are thinking about employing biology with the clinical and pathologic features." That'll either be a one or two sales call and educational effort, or it's going to be three or four. I would really discard anything that we see in the third quarter. Fourth quarter might give us an inkling, but really, I think it's fourth quarter compared to 2Q 2021.
Okay. That's still very helpful, Derek. Dr. Wysong, on the current guidelines, just wanted to get a sense of if you look at the current Brigham and Women's guidelines, what are some of the blind spots, and how well is the recognition that those blind spots exist in the current guidelines? I mean, how well is that recognition among the Mohs surgeons and just the broader Mohs surgeons into the community setting? Any view there?
Yeah. Great question. I would say among Mohs surgeons, for sure, the awareness is very high. We all see these patients every day that maybe have one high-risk factor, and they're kind of on the edge, and we don't really know what to do with them. What I always say is it's extremely hard to predict which one of these patients is going to be fine, go home, we just watch and wait, or someone that's going to rapidly metastasize in three months. Yes, the factors that have come out over and over again for Brigham and Women's staging and AJCC include depth of invasion, perineural invasion, size greater than 2 cm. Those are kind of the key ones. Now, we know that those are independent predictors of metastasis. Those have been shown in the literature across the board.
When we actually in our new paper that's about ready to come out, when we actually compare individual risk factors, again, to tumor biology, tumor biology really outperforms any one of those individual risk factors when it comes to predicting metastasis. It just makes sense, right? Because when we take one slice of a tumor, whether it is a size or the depth of invasion, there are all kinds of ways that that might be misdiagnosed. Depth, for example, is really challenging to actually measure in squamous cell carcinoma. Number one, the vast majority of tumors are transected on biopsy. Number two, the vast majority of these tumors are treated by Mohs surgery, which allows for complete margin assessment, but does what's called en face or horizontal sectioning. It is really challenging to get a final depth of invasion.
There are a lot of what you would call blind spots to staging because we do not always get the final, we cannot always tell for sure whether or not they are the final depth of invasion. Perineural invasion is another extremely challenging one because unless a tumor is sent off for exhaustive vertical sectioning, we can often miss perineural invasion. There are lots of challenges about the size of the nerve, how many nerves are involved, what the depth of the nerve is that is involved. It is not a black and white risk factor in and of itself. I think across Mohs surgeons, to directly answer your question, I think we recognize that there are a lot of holes in traditional staging, and that comes up over and over again.
I would say the population that probably needs a little bit more education is going to be the general dermatology population. However, again, and/or the non-dermatology population is going to need to have a little bit more education around risk factors. Again, I would say the majority of SCCs, particularly on the head and neck area, are going to go to a Mohs surgeon or a surgical oncologist for treatment, primarily though Mohs surgeons. Further education of our entire colleague group is going to be important for sure.
Okay. That's very insightful. I am wondering if you look at the cutaneous melanoma AJCC existing guidelines, they're fairly ingrained in. Compared to that, how would you say are the current guidelines in squamous cell carcinoma? How well are they ingrained in? Is it what is it going to take in order to sort of push it over the chasm, if I was to say, in order for broader adoption into the marketplace among the dermatologists and across the board? Is it data? Is there more to this? Can you elaborate on that?
Great question. I think there's been a lot of movement around high-risk squamous cell carcinoma in the last five years alone. I think there's increasingly an acknowledgment of the fact that we have not done a very good job at assessing these typical clinical or pathologic risk factors. CAP is a group that comes out for the National American College of Pathologists, and they are now recommending actually doing the typical measurements, Breslow's depth for squamous cell carcinoma, looking for perineural invasion. The latest NCCN guidelines—I'm sorry. Yes, the latest NCCN guidelines also look at when you look at pathology for squamous cell, are recommending that. Now, the adoption of that, I would say, is a different thing. I would say most major academic medical centers at this point are doing complete staging for squamous cell carcinomas, particularly if there's any risk factor of any kind.
I would say larger adoption around staging for squamous cell carcinoma is definitely behind melanoma nationally, but I think we're getting there, both in terms of just ongoing education of colleagues as well as just more and more data coming out about the importance of staging squamous cell carcinoma. I really do think that DecisionDx coming out is really going to help us, again, look at, well, now we've got a prognostic method that can really help us do something about it. It's even more reason to be staging, to be thinking about these single identifying these risk factors so that we can ultimately go on and better predict these patients that are going to be developing metastasis and ultimately poor outcomes.
Okay. Great. That's very helpful. I look forward to your papers. Thanks, Derek.
Thank you, Puneet.
Thank you. Our next question will come from the line of Catherine Schulte from Baird. You may begin.
Hey, guys. Thanks for the questions. Congrats on the launch. Thanks to Dr. Wysong for your contribution to today's call. It's been super helpful to hear your perspective on this. I guess first for Derek, maybe, have you done any survey work with your current ordering physicians to see what portion of your ordering base would be interested in the SCC test? I'm just trying to get a sense of what kind of pent-up demand there might be in your existing customer base and what portion have been aware of this upcoming launch.
We have done work. We haven't disclosed. We did not signal launch timing to a broad group, mainly because we weren't quite sure what the daily news role of COVID might push back or accelerate launch timing. I think that if you call 10 dermatologists in Nashville who might be customers of ours and say, "Hey, you heard about the squamous cell test?" I think the answer will largely be somewhat no, except they got an email pushed from their local representative on Monday morning at 8:00 A.M. Maybe that changes. We did not want to, I guess, overpromise the timing of launch given we were trying to balance having a test out there ethically for patient care against the ethicalness of maybe balancing safety of our representatives and our customers. That part.
Now, that being said, I think that if I look back on the market research work that we've done and the individual clinicians who chose to participate in kind of one-on-one or group calls, I can't think of a single clinician who has not said, "This is something I need. This is something we'll be using." I don't want to give you any more quantitative than that because we'll try and maybe roll it out here with having more packaged up for a subsequent call, Catherine. That's not necessarily surprising, right? I think people who have thought through the value of tumor biology and melanoma, I think it's not that difficult to conceptualize that over to a squamous cell.
I think what is surprising and the reason why slide 26, for example, was put into this presentation deck looking at univariate and multivariate analysis compared to individual risk factors is we originally assumed that the majority of clinicians were sort of formally staging using AJCC or, as Shung Ji indicated, hospital system, BWH system. As we got deeper into the research, we realized that, yes, there are pockets of clinicians who are following that or have been following that pathway. The majority of dermatologists and Mohs surgeons that we've talked to are thinking in terms of the presence or absence of individual risk factors. Now, that, of course, rolls up the staging. Unlike melanoma, where I think they put that in sort of a staging bucket intellectually, that seems to be not quite at least it's very early on, as Dr. Wysong said, in SCC.
Does that answer the questions without answering the question?
Yep. Yep. Very helpful. I think you talked about there being somewhere around 10,000 clinicians you're targeting on the cutaneous melanoma side. I believe there are about 2,000 or so Mohs surgeons out there. Can you just help us think about how concentrated? I believe there are about 2,000 or so Mohs surgeons out there. Can you just help us think about how concentrated SCC is versus cutaneous melanoma from a pull point perspective? Is it those 2,000 Mohs surgeons handle 70% of cases where a patient has a high-risk factor? How penetrated are you within that Mohs surgeon category through your CM product?
Yeah. I'll answer that. I asked Dr. Wysong to correct me publicly here if she has a different viewpoint kind of. One is that Mohs surgeons are fellowship-trained surgeons, of which I think 100% are dermatologists first. Mohs surgeons are really part of that 10,000 number if that's a real number, not an addition to. Within that 10,000 number, I think there are also a number of physician assistants and nurse practitioners who work in dermatology full-time. Of course, there are also probably some people who are doing more cosmetic work as a practice versus medical derm, but people who go in to see a dermatologist for cosmetic purposes also, by the way, get skin cancer. There's some overlap there. Our perception of the kind of normal patient journey—and this is where I'd like Dr.
Wysong to correct—is if it's kind of a non-skin cancer patient who goes in for a skin exam, has a biopsy by a dermatologist as their frontline skin doctor, comes back squamous cell carcinoma of the skin, my presumption is that at least that 20% with high-risk factors, if not, I don't know how many more, they're going to have their definitive surgical, the removal of that primary tumor, performed by a Mohs surgeon. Mohs surgeons, to my knowledge, are nearly 100% skin cancer surgeons. They're looking at basal cell, squamous cell, and melanoma. Now, an existing patient who's had squamous or basal melanoma and had that tumor removed by a Mohs surgeon, I think you see a mixture out there where you see some Mohs surgeons that essentially do surgery and don't really do follow-up care for patients depending on practice referral patterns, etc.
You have other Mohs surgeons there who actually maintain patient follow-up and care. I don't have a handle on the proportion of that number or not. Maybe Dr. Wysong, you can add some clarity here.
No. I think your assumptions and numbers are right on. If Mohs surgeons are included in that 10,000 number, and I think you mentioned earlier about 80% of that 10,000 is dermatologists. Is that right?
Yes.
Yep. Exactly. I mean, to me, that's really going to be encompassing the people that are treating squamous cell carcinoma. Now, melanoma overall, as you mentioned, 92% of all melanomas are localized on presentation. A very high percentage of melanomas are still primarily treated by dermatologists or Mohs surgeons. I would say a higher percentage are involving our surgical oncology or head and neck oncology surgeons to do sentinel lymph node biopsy on appropriate patients. Whereas with squamous cell carcinoma, I would say a very high percentage of those are treated by the dermatologist or Mohs surgeon. In terms of referral patterns for wide local excision by a dermatologist for a Mohs surgeon, that really does vary by region and by practitioner.
However, I would say the vast majority of people, if it's a squamous cell on the head and neck, hands, feet, or other high-risk areas based on Mohs-appropriate use criteria, the vast majority of those are going to be treated by the Mohs surgeon. I would say that's probably about 85% of squamous cells out there, to be honest, maybe even closer to 90% depending on the patient age and population. I don't know. Derek probably has better data on this, but I would say the awareness of Castle in the Mohs surgeon population is very high.
Okay. Very helpful. Maybe one follow-up for you, Dr. Wysong. Just as you talk to your colleagues and peers about this type of test and its use case, what are areas of pushback either that you hear or that you think Castle might hear as they start marketing this test?
Great question. I think everybody wants to know kind of how it's going to work in terms of billing for patients, insurance, what the process looks like in terms of the day-to-day. I think overall, Castle's done a fantastic job of making it really easy for the physician or clinician's office. As Derek mentioned earlier, we basically fill out a form and kind of sign it, and it gets faxed off, and then Castle really takes over from there. I would say kind of patient education and being able to very easily say to patients what it's going to look like and how their insurance is going to be billed, which, again, I think Castle's done a very good job of, is extremely important. I think how quickly can we get this information back, those types of things.
I would say, as Derek mentioned earlier on, overall, the integration of tumor biology and gene expression profiling into oncology across the board is relatively well accepted at this point. I do think, and I've felt this way for years, and this is why I'm so passionate about this project and about this company, is because this is an area of just complete need within dermatology and I would argue within oncology across the board. As mentioned, we treat a million squamous cell carcinomas a year. When you look at 20% of those are high-risk, that's a very, very high number of patients and people that we're dealing with. While as an individual doc, I may order the DecisionDx-Melanoma test a couple of times a week, I'm seeing a lot higher number of squamous cell carcinomas in terms of just sheer number of patients.
I think the need is enormous, and I'm really, really excited for this to launch and to ultimately see how it impacts our patients. Again, I think squamous cell carcinoma is an area where patients may get increased amounts of radiation, increased amounts of whether it's true radiation or CT scan radiation based on a single risk factor or kind of gestalt is really going to be replaced by evidence-based medicine and precision medicine utilizing that patient's very own tumor biology. This is absolutely the way of the future. You can tell I'm excited. I just can't wait to integrate this into my patient population, honestly.
All right. Perfect. Thank you.
Thank you. Our next question will come from the line of Max Mazzucci from Canicore. Please go ahead.
Hi. Thanks for taking the question. First, for Dr. Wysong, so a DecisionDx-SCC test result can be useful for multiple different decision points, including decisions about surgery, about imaging, and about adjuvant therapy. Can you just walk us through the value DecisionDx-SCC provides at each of these decision points? I guess more specifically, just whether you think any of these three decision points may be utilized more than another. Thanks.
Fantastic question. This is literally what we're mulling over all of the time. I think you are right on in that there are multiple decision points where DecisionDx-SCC can be helpful. Really early on, when you're trying to decide the initial surgical treatment modality and whether or not this is a high-risk tumor, that can really help push maybe a general dermatologist to referring to Mohs surgery for comprehensive complete margin assessment. It's going to also then, I would say, help us decide whether or not we want to consider nodal imaging or formal pathologic nodal staging for that kind of moderate to high-intensity or 2A, 2B group. You're absolutely right.
It might be that sometimes we do not find out until after surgery that there is a higher risk feature or this ended up being a lot larger, a lot deeper than we thought. Even post-operatively, if it has not been ordered, DecisionDx-SCC could absolutely be ordered at that decision point as well, which would impact, again, need for nodal imaging, nodal staging, or adjuvant radiation or other therapies. The final part is for that high-risk tumor that we have already kind of placed maybe into a 2A or a 2B group. These are the patients where I literally say to myself, "Okay. So it is not a matter of if.
It's a matter of when the cat gets out of the bag." If I've got a patient with one or more high-risk factors, clinical pathologic, and now all of a sudden I've got a Castle 2B result, you better believe I'm thinking about other types of adjuvant therapy. I cannot wait for the investigator-initiated studies and additional studies that are going to be coming down the pipeline to really look at prognosis of DecisionDx-SCC in terms of predicting patients that might benefit from further adjuvant treatments, whether radiation or adjuvant systemic medications as well. Yeah, we're already thinking down the line about how to utilize this. I really can't wait to see how, again, integration of tumor biology is going to absolutely change the way we manage patients.
I think the best thing is identifying that group of patients that really can benefit from some additional therapy where those additional risks, those side effects are worth it for those patients because we know the cat's out of the bag or on its way. I'm really excited about where we can utilize DecisionDx-SCC and multiple decision points along the way for these high-risk SCC patients.
Great. That perspective is very much appreciated. Maybe one for Derek or Frank. Can you just help us understand how the economic benefit of DecisionDx-SCC compares and contrasts from DecisionDx-Melanoma and just if there's any differentiating factors that might be in play here? Thanks.
Yeah. I think nice question, Max. The economic model that we've shared with and used with Medicare shows such a high extraction of being able to reduce unnecessary sentinel lymph node biopsy procedures in people with a very, very low likelihood of being node positive and couple that with a very, very high likelihood of being alive at five years without that procedure, no intervention being done. That shows tremendous extraction out of the Medicare trust fund, assuming that clinicians follow the results of the test as part of the treatment plan. For squamous cell carcinoma, I think we'll be generating some confirmational data here in the next sort of three, four, or five, or six months.
I think, one, it should be a positive extraction story because you're going to be able to eliminate or reduce, I would say, early use of radiation therapy, early use of systemic therapy, maybe reduce some of the nodal staging or the sentinel lymph node biopsy procedures being done, as Dr. Wysong said, in more of the academic centers that's also spreading out. Being able to kind of downregulate or de-escalate care in somebody with one or two or three high-risk features who actually has very low-risk biology. I think that's a pretty easy cost extraction. That being said, I think we're going to also find, though, that there are patients with one or two high-risk factors or more that are sitting in a Mohs surgical practice who maybe that Mohs surgeon is a little more conservative. I don't mean that in a negative manner.
Just medicine is medicine. Maybe the sort of standard care of a high-risk patient had been a watch and wait because if I'm only using something like NCCN criteria for high risk, that means that there's only about a 14-15% chance of metastasizing. You have seven high-risk people in your waiting room. I'm certain that there are some clinicians who are saying, "Do I actually send all seven when only one needs it?" That is a difficult risk-to-benefit ratio. Whereas if you have one high-risk feature or two or more and a high-risk class 2B signature, you have greater than 50% chance you're going to metastasize within three years, and half of those occur about 11 months out.
That's a much different equation to say, "Man, we should send that patient to a surgeon and see if we can find a positive node and maybe qualify them for PD-1 inhibitor therapy today and/or radiation to slow that train wreck down a bit." I would hope that we would see an increase in expenses in some patients because they're actually getting treated more properly. I think the biggest impact will be able to support a de-escalation of interventions in people who might appear high-risk on pathology, but maybe the best choice is much more of a low-intensity follow-up and care pattern. Does that answer the question clear enough? Dr. Wysong, do you want to jump in and correct this slightly or?
No. I would completely agree. I think the cost savings is really going to be the de-escalation of care of those low-intensity or Class 1 patients or even Class 2A that otherwise has a lower risk or moderate risk tumor biology, but that may have multiple clinical or pathologic risk factors. That de-escalation of care goes beyond, I would say, also the financial. There are a lot of side effects that come with radiation. There are a lot of side effects that come with chronic imaging with CT scan. There is multiple follow-up. If we're seeing them four to six times a year, that's a lot more time from their lives as well. I think that de-escalation of care is going to be fantastic economically on our healthcare system.
Then simultaneously, yes, there's going to be an increase, but in a much smaller number of patients, and it's going to be a targeted approach to the more aggressive management strategies such as radiation, PD-1, or other targeted inhibitors that we don't even know about right now. While sentinel lymph node biopsy may be one thing to consider, if we know based on the multiple risk factors plus a Castle 2B signature that there's a 50% risk of metastasis, whether or not that sentinel node is positive or negative, I would still argue that that patient still may very well benefit from some kind of systemic treatment. I think there's so many exciting unanswered questions that I can't wait to start working on.
Great. Thanks for taking the questions and congratulations on the launch.
Thank you.
Thank you. I am not showing any further questions at this time. I would like to turn the call back over to Derek Maetzold for any closing remarks.
Okay. I want to just first say thank you to Dr. Wysong for moving her surgical schedule around and being available to participate in bringing in an opinion of one of the leading Mohs surgeons across the U.S. One of the things she did not disclose to you was that when we were setting up our initial program to see if we could actually accomplish what we have accomplished, Dr. Wysong was one of the first individuals referred to us saying, "If you want to get critical feedback on somebody who balances science and clinical output, you have got to somehow suck Dr. Wysong into your program." She very nicely accepted that invitation, by the way, and has been one of a small group of our steering members to really provide consistent input and pushback.
As you heard her say now, the next exciting part is mapping out the next stage of evidence development so we can really make sure that clinicians and patients are maximizing the value of our test results. That is exciting. Thank you for that, Dr. Wysong. Of course, to our patient base and our other collaborating centers and our employee base, it has been a wonderful couple of years going from a concept to a clinically available product, and we are looking forward to the next several years going forward. With that, I thank you for your participation and for dialing in to the webcast, and wish everyone a healthy and safe Labor Day. Bye-bye.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.