Good afternoon, everyone. Thank you for joining us today, and thank you for your continued interest in IMOUVIA. Today's quarterly report presentation is a historical one as it is the first presentation as a commercial company. We have now passed a pivotal milestone in the company's history. Immunovia Inc.
Has launched IMRAPAN can D as a laboratory developed test in the U. S. This is a major achievement for all of us here at immunovia and provides an opportunity for doctors, patients and their relatives to access the first blood test for early detection of pancreatic cancer. It is truly groundbreaking. My name is Patrick Dalleen.
I am the CEO of IMMANOVIA, And I will be presenting the quarter 2, 2021 results for IMMANOVIA. Together with me on the call It's also our Medical Director, Doctor. Thomas King and Cindy Callahan, our Senior Marketing Director at immunovia Inc. Tom and Cindy will give some additional color on our Imre pan Candi test and its launch in the U. S.
Next page please, Page 2. Here you can read our disclaimers and forward looking statements, and I encourage you to read these at your leisure. Next page please, Page 3. Today's agenda is as follows. I will start by giving you a summary of Q2 highlights and updates on post period events.
Obviously, the launch of IMRAP and Candi in the U. S. Is the key event at this time and marks a significant milestone for IMUNovia. Then I will hand it for IMUNovia. Then I will hand it over to Tom for a discussion on MIMRA P and Candid testing in the U.
S. And he will give you an update on the test performance and the next steps. Next, Cindy will discuss the marketing activities that we have initiated to ensure successful launch of IMRAP and Candi in the U. S. I will then comment on our pipeline projects in discovery stage.
Following that, I will briefly touch upon the financials for Q2 2021. And following financials, we will go into a Q and A session. Next page, please, Page 4. Now I will move on to discuss Q2 2021 highlights. Next page please, Page 6.
The Q2 of 20 21 was again a very busy quarter for immunovia. Immunovia Inc. Received a clear certificate of registration, which is a prerequisite to receiving a clinical laboratory licensure, the Massachusetts State Department of Public Health Approval that was received after the end of the period. We are extremely proud to have achieved this pivotal milestone. It means a lot to us as a company.
It means a lot to people working in the field of pancreatic cancer And it means a lot to individuals who have a family history of pancreatic cancer or have a genetic predisposition and therefore are at risk of pancreatic cancer. As a result of the updated guidelines from U. S. Preventive Services Task Force, The National Comprehensive Cancer Network, American Society of Clinical Oncology and the International Cancer of Pancreas Screening or caps. We presented an updated assessment of the total market size for familial hereditary pancreatic cancer risk group in the U.
S. Immunovia's new estimate shows that 315,000 to 350,000 individuals have a familiar hereditary risk of pancreatic cancer and would qualify to be included in surveillance programs. This means that with twice a year testing, the total number of tests would be 700,000 tests per year. If in the future, the new recommendations to test all individuals with just one first degree relative affected by pancreatic cancer were to be implemented, the number of individuals at risk increases to roughly 1,500,000 individuals in the U. S.
Obviously, it is of tremendous importance that key opinion leaders continue to drive this new inclusion criteria, And it is evident that a blood based test such as IMBRATE and Candi is a prerequisite and a key enabler for managing such large surveillance groups. In the quarter, we also reiterated the road to reimbursement for IMRADE CARCANDID as a laboratory developed test in the U. S. Immunovia Inc. Will start by exploring a positive Medicare coverage and the aim is to obtain coverage and reimbursement agreements with the majority of U.
S. Payers prior to year end 2022. Thus, we have a clear strategy and a clear path towards reimbursement. Furthermore, immunovia hosted a key opinion leader event for investors on the clinical need and use of IMRAP and 10b. 3 prominent experts participated and presented their perspectives on how the test can be used in clinical practice.
Doctor. Steven Perera, Professor of Hepatology and Gastroenterology, University College London Doctor. James Farrell, Professor of Medicine at Yale School of Medicine and Director of Yale Center of Pancreatic Diseases at Yale New Haven Health and Doctor. Jeffrey Burns, MD from Renaissance Family Medicine of Wellesley, Massachusetts, U. S.
The conclusion from the discussions were very supportive of the use of Imre Pancandi for early detection of pancreatic cancer. Not only in the high risk group of familiar and hereditary, but also in the early symptomatic individuals. Thus pointing to the future potential of IMbrey PANCKD as a widely used test for early detection of pancreatic cancer. Imre Pancandi was highlighted at the seminar organized by the largest patient organization in the U. S, the Pancreatic Cancer Action Network.
Doctor. Rosalie Sears, Co Director of the Brandon Carlson Center for Pancreatic Care and Professor at Oregon Health and Science University as well as advisor to PAMCAM expressed her enthusiasm for the test's accurate ability to detect early stage 1 and 2 pancreatic cancer. Next page please, Page 7. After the close of the quarter, we, of course, announced the most significant event in the history of IMUNovia. On August 3, Immunovia Inc.
Received a clinical laboratory licensure from the Massachusetts Department of Public Health. This means that immunovia Inc. Has been approved to begin commercial testing with the IMRAP and can D test in the U. S, exclusively through the laboratory in Marlborough, Massachusetts. The first tests have already been sold.
The first tests have now been analyzed in the laboratory and the first invoices have been issued. Next, IMUNovia provided 2 updates regarding IMRAP and NT test. First, the test is launched at the list price of US9.95 dollars per test. Based on feedback from the payer study, we saw a clear chance to adjust the price as there seems to be a relatively large price elasticity among payers for a blood based test for early detection of pancreatic cancer in the U. S.
In comparison, the price for MRI and endoscopic ultrasound scans are in the range of US5000 dollars to US6000 dollars 2nd, the test is launched for those individuals with CA99 levels greater than 2.5 units per ml. And Tom will dive deeper on that subject in his section. The overall sensitivity of the test then improves to 89% in Stages 12 and 92% in all stages. The specificity of the test is 99%. Next page, Page 8, please.
And now I hand it over to you, Tom. Tom, will you tell Tom will tell us about the Imbere pancreptending testing in the U. S. Tom, please?
Thank you, Patrick. I'd now like to update you on our clinical operations in the United States through Immunovia Inc. Slide 9, please. Our laboratory is now licensed in Massachusetts as Patrick has indicated And that authorizes us to perform patient testing not only in Massachusetts, but in 44 other U. S.
States that do not require in state licensure. While our CLIA certificate from the federal government was issued in the expected timeframe, The Massachusetts state inspection that is required for state licensure was substantially delayed by COVID issues in the state bureaucracy. At the time of our inspection on August 3, we also found that Massachusetts procedures for laboratory licensure have changed with COVID. In the past, the initial inspection would have been followed by reinspection in 90 days with biannual inspections thereafter. These processes have now been eliminated and we expect no further state inspections of our laboratory.
We filed our College of American Pathologist application very soon after we received the state licensure And we expect a visit from the College of American Pathologists within approximately 6 months for that accreditation inspection. Slide 10, please. I next wanted to speak in more detail about how we are applying IMRAPAN Candid in the U. S. As you know, CA99 is an important component of the Emray Pan Candi signature.
CA99 is an oligosaccharide that is formed by the sequential addition of different sugar units to form a tree like structure. The final sugar addition that is required to form CA19-nine It's catalyzed by an enzyme called the lewis antigen because it also plays a role in blood transfusion immunology. In this diagram, the lewis antigen is indicated by the large lsmalle in the illustration. If an individual has 2 defective copies of the Lewis antigen gene, they are then unable to add this final sugar to form CA99. And the lack of CA99 expression will affect the results of the MRAPAN Candid test.
The frequency of individuals with this genotype vary substantially in different ethnic groups. So test performance could be Affected substantially in different ethnic groups. Slide 11, please. We found from the literature that Genotypic analysis has shown that individuals who are deficient in the Lewis antigen gene have very low levels of CA99 measured in their serum compared with individuals with 1 or 2 functional copies of the gene. This then provides an opportunity to provisionally classify individuals with CA19-nine levels below 2.5 units per milliliter It's Lewis antigen null.
Slide 12. Based on this information, we've Examine excluding Lewis antigen null individuals from IMRAY PancAD testing. This improved test performance and our blind validation quite substantially, increasing test sensitivity from 85% to 89% for early stage PDAC And from 87% to 92% for all stage PDAP without compromising test specificity. I feel that this is an essential step for the clinical application of Imri Pan Candide because it both improves its clinical performance and avoids providing inferior results to some ethnic groups in the U. S.
Slide 13, please. These sensitivities and specificities that I've described imply positive and negative predictive values that are shown in this slide for at risk populations with prevalence of PDAC of 1% 3%. As you can see, the negative predictive value exceeds 99 percent in both groups. The positive predictive value nears 75% for early stage TDEC in a group with 3% prevalence and nears 50% in the group with 1% prevalence. I feel that this test performance We'll be very helpful in guiding clinical decisions in at risk individuals.
Slide 14. I'd now like to say a bit about our next steps or steps that are in progress. As Patrick mentioned, we have now vetted all of our sample receipt, Analysis, reporting and billing operations and are currently performing patient testing and will continue to do so as new orders are received. We are nearing completion of a manuscript of our blind validation study for peer reviewed publication. This work has been accepted in abstract form for presentation at the American College of Gastroenterologists meeting this fall.
Analysis of pan pan samples has begun in IMUNovia Inc. And we anticipate completion of this analysis in 2021. Evaluation of IMRAPAN can G performance in individuals with pancreatitis is underway with one of our key opinion leaders in the U. We are also preparing to evaluate newly collected samples from symptomatic individuals to confirm and extend results reported from the lung laboratory in 2020. Based on our initial results, we are optimistic that these findings will support Offering Imri Pan Candi to symptomatic individuals.
I'd now like to turn the discussion over to Cindy Callahan, our U. S. Marketing Director. Slide 15, please.
Thank you, Tom. Hello, I'm Cindy Callahan. I'm the Senior Director of Marketing for Immunovia Inc. In Marlborough, And it's my pleasure now to review the launch and marketing activities for the Imre Bank Lending Test. Next slide please, Slide 16.
Well, we certainly had a lot to introduce and reintroduce to the market on August 4, a new laboratory, a new test, a new tool for the early detection of pancreatic cancer. We want to introduce Immunovia Inc. And the Imri Pan can key test with a new look and feel versus Immunovia AB. If you haven't visited our website, I invite you to take a look at immunoviainc.com. You'll see we made 3 very important commercialization very clear and easy to find on the homepage.
Pay My Bill where patients can pay for their test, the provider Portal where ordering providers can place orders electronically as well as receive their results in the same manner and a test requisition to either download and print Or complete the fillable PDF. The goal of the website was quite simple really, appeal to patients and physicians without complexity. We at Immunovia Inc. Do imagine early detection and the hope that comes with that and we feel the brightness of the entire site along with the splash of color, Including purple, of course, demonstrates that. Immunovia Inc.
Also launched brand new social media accounts on Facebook, Twitter, Instagram and LinkedIn. This engagement strategy is designed to appeal to all those out there with a hereditary or family history of pancreatic cancer and educate them on their elevated risk for developing the disease. Last, as important as a test for the NYTAN-1D test is, it really requires a logo. So with the launch of the website and social media campaigns, we also introduced our new Emray PanCandy logo. Next slide please, Slide 17.
From a 4 page brochure designed with a position in mind to collection kit Objections for the phlebotomist. Our goal is to provide all the key stakeholders with the information they need in order to understand the inripecan testing test And the logistics associated with ordering it. The patient flyer provides information on risk groups associated with pancreatic cancer. And as patients, we know conversations with doctors can be intimidating and that's why we created some helpful tips that can be used When a patient talks to their doctor about the IMRAPAN can be passed. Patients can feel empowered when speaking to their physicians when they have factual information they can share to improve their health.
We also created a 1 page what to expect flyer, so patients know exactly what to expect after the test is ordered. This piece includes information regarding the collection kit, remote phlebotomy, result reporting and invoicing. These materials are all available on immunoviainc.com and we always encourage people to contact our customer support team to answer any questions they may have. Next slide, Slide 18 please. So while we were well prepared for the launch of the IMRa Pancandi test, it didn't prevent us from being a little busy the 2 weeks.
The anticipation had been building, which made the launch even that much more exciting. We've always envisioned a campaign around imagine early detection. And after attending dozens and dozens of pancreatic cancer awareness walks, we had a pretty good understanding that early detection and the importance of it meant different things to different people. So we reached out to those folks who met at WACC and asked them simply, what does early detection mean to you? We had an overwhelming response and no two sponsors were alike.
This Imagine campaign, as we call it, became our launch campaign. We're told time and time again how relatable it is. It's not just about maybe living longer, it's about the little things in life, a phone call with your mother, tea time with your grandfather, teaching a grandchild to play the piano. So it's been a very powerful campaign for us. Next, I'll talk a bit about our pancreatic cancer awareness night.
Boston, as you know, is home to some of the best hospitals in the country, Mass General, Beth Israel, Dana Farber to name a few. It's also home to some of the best sports teams. One in particular is the Boston Red Sox, which is a baseball team. Strangely, people all over the country follow the Red Sox and they call it Red Sox Nation. There's even a few pancreatic cancer survivors and patient organizations who call Boston home.
Generating awareness is tricky to measure, but we figured since we're in the Boston community With all these resources around us, we've tried something a little different. We partnered with the Red Fox to have a pancreatic cancer awareness night at Fenway on August 13. This included purple ribbons for the game day staff, a pregame ceremony honoring some survivors, a table in the concourse with information on the IMRAY Pancandi test and a commercial that played on a large screen. We also invited local members of patient organizations, Organizations like the Pancreatic Cancer Action Network, the National Pancreas Foundation, Force, Deepak Together and the Pancreatic Cancer Alliance. That night generated more buzz than we ever imagined.
Many of our KOLs were following the night on Twitter and I even received text messages from acquaintances in Denver, Colorado Same they saw Immunovia Inc. And the pancreatic cancer awareness line, SNH. Social media metrics for the night and many days after had been significantly increased. We even had people in the stands requesting purple red socks IMUNovia T shirts so they could wear them proudly. Next, the pancreatic cancer network, as Patrick mentioned, is by far the most influential patient advocacy group in the pancreatic cancer space.
They have over 1,000,000 constituents and support patients and their families in many different ways. Because of the services they provide, they have a fairly large service patient services team to answer incoming calls. On August 11, we proudly insert in service Pancan's patient services team on the MRI Pancan D test. They were provided with all of our marketing materials and of course the phone number for our customer support team. PANCAN will be highlighting the launch of the IMRAY PancAN D on their website.
Last, about a week ago, Doctor. Tom King was interviewed by a news anchor for a U. S. Network called Spectrum TV. We interviewed with Aird across the country and will be featured on our website and social media channels.
Next slide, Slide 19. For several months and for some of us for several years, we've been engaged with many physicians who run surveillance programs. And now that our tests have launched with a sensitivity of 89% in stages 12 with a specificity of 99%, It's really important for us in marketing to get feedback on how these ordering providers will use the test. I won't read all of these, but just to point out a few. We had one physician say and I quote, I have been following immunovia for years and I'm impressed with the data.
I am committed to sending at least one patient test Per week as I have many worried individuals that don't fit surveillance program criteria. It is tough to get an MRI coverage for that type of patient And Imray Pan Candi is a good option. Another quote I'll read aloud is from Doctor. K and it reads, I don't believe current imaging options are very good and believe mRADE pan candy should be run on every individual with 1 first degree rifle. Next slide please, Slide 20.
Prior to launch, Immunovia Inc. Has always had a presence at relevant conferences in the spring and fall. And I'm very pleased to say that we will have a booth at all the conferences in the fall, whether live or virtual, and we also have several presentations planned with KOLs. However, with the increasing numbers associated with the delta variant, we're unsure if some of these live programs will be switched to virtual. We will have to wait and see on that.
Next slide, Slide 21, please. Some of the other activities that we are planning in the coming months include A ribbon cutting ceremony or a grand opening in IMUNovia Inc. At the end of Q3 or Q4. As far as World Pancreatic Cancer day is concerned, we've become known for getting building that purple in world pancreatic cancer day. Last year, we were involved with over 300 lightings And this year our goal is to beat last year's number.
We will continue with the Imagine campaign, but we will shift gears a little bit and invite people to submit pictures and quotes To the question, what does early detection mean to you? And this will be strictly a social media campaign. We have numerous advertisements planned for social media and Google. Those will begin launching over the next week or so. And we have a number of webinars that we are coordinating with patient organizations, which will be posted on Immunovia Inc.
And social media. We continue to receive requests for interviews from different media outlets And those will also be communicated on all the digital channels. And with that, I will hand the presentation over back to Patrick. Slide 22, please.
Thank you very much, Cindy. And on Slide 22, we'll say a few words about our pipeline. Next slide, please, Slide 23. Our main focus has been on the launch of IMRAPAN can be for early detection of pancreatic cancer, and this important milestone has now been achieved. There still remains work to be done for IMMANOVIA in the area of pancreatic cancer, such as more clinical studies, particularly in the high risk group, new onset diabetes or NODs, U.
S.-based studies for reimbursement purposes, confirmatory testing of the symptomatics and so on. There are great opportunities for immunovia to continue to dive deeper in the pancreatic cancer space. We also obviously continue to evaluate our discovery platform in other clinical areas. We currently perform early stage discovery studies in the area of rheumatoid arthritis and lung cancer. We have established key opinion leader networks for these discovery studies, both to secure we have the right knowledge mass and of course to secure high quality samples from well defined disease cohorts.
As you know, collection of samples is still affected by the COVID-nineteen pandemic, a pandemic that in the world now is on its 4th wave. As these are discovery studies, meaning they are in early stage of our R and D model, it is not my intention to give firm timelines on these 2 discovery studies at this stage. We will report data when we have new data and information. Next slide, Slide 24. Briefly, a few words on financials Q2 2021.
Next slide please, Slide 25. Our net sales in Q2 2021 was SEK 38,000. This is some minor royalty income. Net earnings in the quarter was minus SEK 49,000,000. Cash flow in the quarter was negative we had a negative cash flow of SEK 44,000,000.
Cash and cash equivalents at the end of the period was SEK382 1,000,000. Based on current burn rate, we have a run rate of over 1.5 years at current full year levels. These projections do not include cash contributions from sales in Q3 nor Q4 2021 nor for the full year 2022. We will report sales numbers for the first time in our Q3 report. As we present Q4 results for 2021, we will give sales guidance for the first time on a forward looking basis for full year 2022.
With this, I want to turn to the next page, Page 26, and open up the call for Q and A. Operator, please.
Thank
IMUNAVIA. Our first question comes from the line of Victor Sambhai of ABG Sundal Collier. Please go ahead. Your line is open.
Yes. Hi. Thank you for taking my questions. So two first, if I may. So on the last changes you made to exclude individuals deficient in the Lewiston, what will be the implication on that the prospective studies currently recruited or ongoing, will you go back in, for example, PanFam and remove samples that you collected with a low C99 value?
Or can you Go through how this knowledge impacts the prospective studies or future studies going forward? Thank you.
We always when we Ron, thank you, Victor, for your questions. Always when we run the analysis, we start by running the CA99 value. So we will know that the individual has a low CA99 value and then not proceed from there if it's a crucial study. But maybe, Tom, it's better for you as you are deeper into the details to respond to the question. Yes,
certainly. We're running the panfam samples exactly as we run clinical samples. So for reporting purposes, if the CA99 is below 2.5, we reported as tests not performed. Actually though, from the preliminary analysis of our blind validation, individuals with very low CA19-nine levels, If we remove the CA99 from their signature, there still was substantial predictive value from just the MRA portion of the assay. So we're looking at that to see if there's a possibility for a companion assay to be paired with it.
If that's the case, then I think it makes sense for us Collect that information from the Panfam subjects as well as we may be able to use some of that information going forward.
Okay. Thank you. Great. And on CAP that is now filed, is that Would you say critical for a larger sales uptick from here? Or do you see it more as a, if you will, nice to have feature with regards to the uptick of your text?
Thank you.
Well, in general yes, go ahead, Tom.
It certainly is a measure of quality That I think is recognized around the world. So it is important for us. I think in terms of clients such as surveillance programs, CAP accreditation will be important. Probably even more important is the peer review publication And that's moving forward very nicely. We've got responses on that from more than half of our KOL authors.
So I'm hoping to move that forward quickly. I think that will give us a really large boost in terms of response from surveillance programs.
Okay. And building on your sales uptake, could you give any comment if you plan to offer any rebates here In the beginning to drive adoption and what level of rebate are we talking about in conjunction with your new price guidance?
It's very common in our field to have rebate programs. There are rebate programs for People with the pay directly and upfront, they can get a discount for direct payments and then also for people with lesser means, there are discount structures. Cindy, maybe you can comment a bit further on the details.
Sure. So as Patrick mentioned, we do offer Prompt pay discount, which is 25% below list price if you pay within 14 days and anything paid between the 14 21 days, We offer 15% discount. We also offer monthly payment plans and the financial hardship program, as Patrick mentioned.
Okay. Great. And just maybe a final one. I don't want to get ahead of your European launch strategy, but can you give any Flavor of what requirements the new in vitro diagnostic regulation that is coming into play in 2022 will have on the type of Does you need to perform in a European set in order to get the IVD approval in Europe? Is that similar to what you see in U.
S. Or more extensive? Or if you could give any comment, that would be helpful. Thank you.
So we have communicated that we will give a market update with regards to the European launch and we will do that relatively soon. We have given priority to the U. S. Launch and sort of making sure that, that happens and we will follow with the update on the European launch and the road to market for Europe shortly. So you will have to be a little bit patient with that still.
Okay, sure. Thank you.
Thank you. Our next question comes from the line of Lars Heffring of Danske. Please go ahead. Your line is open.
Thank you. Can you just please remind us about the supply capacity at the Marlborough site, where it Stands today. And of course, whether there are any limitations in terms of input material, Are there any restrictions on the supplies here?
So in terms Of capacity, I think from a manufacturing point of view, we are scaling up with regards to our capacity to supply reagents from Sweden to the U. S. And in terms of the capacity in Marlborough, we are on a hiring spree to scale up our resources there. And maybe Tom, you can comment a little bit with regards to our current capacity and also your view on the scale up over the years to come.
Certainly, Patrick. We have hired, I think, 2 very good technologists that are in the mid portion of their training at this point. So from a human point of view, we should have very good capacity going forward. I agree that Melentes So, Clyde does very well with their reagents. We continue to be very careful about pipette tips and other things that are also used for COVID testing As we've seen substantial slight supply chain disruptions over time, I think at this point, we have a good stock Pile of materials to last for at least 6 months, by projections.
And we continue to look for alternate suppliers going forward. I don't really think the supply chain is going to settle for some time. So we are quite vigilant about that. We use multiple suppliers for those types of consumable materials.
And the testing capacity with the current The personnel and with the current platform in Marlborough Laboratory is estimated to be between 80,000 and 100,000 tests per year and can then, of course, be expanded by further employment of further lab technicians.
Okay. Thanks. And could I just add on this on the change or the question about the CA in 19 19.9. In reality, what's how many people would qualify as being that Not having that low levels, because I guess it's pretty rare, how much would be the qualified, let's say, for this test And some flavor about how that varies between populations?
Yes. So on a global basis, it's roughly 5%, but the challenge is that it varies from ethnicity to ethnicity. So maybe, Tom, you can give a bit more color on the different ethnic groups.
Certainly, Patrick. In our blind validation study, it was about 10% of the population And the majority of those were from the U. S. So the literature says approximately 6% of Caucasians A low CA99 or CA99 novel phenotype, but about 22% of African Americans. There's limited information out there because although, lewis is a blood group antigen, it's It's quite a minor antigen, so it's often not measured.
So there's not very much reliable data in many different ethnic groups.
Okay. I got it. And then the final question from my side. You mentioned Thank you, Christi. And the symptoms that handle symptoms, what's could you say something about more about the plans there and What's the needs and plans?
Was that something to do with ongoing study? Sorry, I missed that.
Yes.
I can speak to that, Patrick. With one of our KOLs who had A repository of pancreatitis and pancreatic cancer samples going back a few years. We did an initial pilot study of about 150 samples to see if we could actually analyze older samples, which had been a problem I think for with some aspects of Imray. We found, I think so far that we can pretty confidently go back about 10 years. So what we're doing now is having that Key opinion leader, look at their repository and see how many more samples we can get.
So we get slightly larger numbers for a more powerful paper. But thus far, I think the results look very promising in terms of chronic pancreatitis having a very low false positive rate. So more to come on that hopefully by the next end of next quarter and get that complete. And justice for the blind validation study peer reviewed publication of those results is what we really need to move that forward.
Okay. That's helpful. Thank you.
Thank you. Thank you. We've had one further question come through. That's from the line Peter Schulz Napoli, Private Investor. Please go ahead.
Your line is open.
Hello, everybody. My question is, I'm happy to see that you have received clearance for your CLIA lab. Could you comment on Whether the clearance of the lab is also closely linked to the clearance of the Pankandi test itself?
Yes, so the test is approved to be used for testing of people with a familiar and a hereditary risk group. So the test is cleared to be used for patient testing or testing on individuals.
Yes. And the second question Excuse me, Tom, a second question. We have learned from Mats and later from Click that. The total available market would be SEK 4,400,000,000. Could you comment on which Part of that huge market would be cleared like of today?
So we estimate now that the U. S. Market potential in itself and I'm now just focusing on the U. S. It's above $4,000,000,000 a year.
That includes 3 risk groups, one being the family and hereditary risk group, The second being the symptomatics, people with various symptoms associated with pancreatic cancer. And then the 3rd, which is a future one, is new onset diabetics. In terms of the high risk group for familiar and hereditary. The size of that is 350,000 people that would be eligible for surveillance in the U. S.
So that is a $350,000,000 market in itself currently with testing once a year and would be with twice a year testing $700,000,000 And as I have mentioned a few times before, For familiar hereditary risk group, there is a increasing push from key opinion leaders to move the inclusion criteria towards one near family member who has had pancreatic cancer to be included in surveillance programs. And that would push the Available or individual the numbers of individuals that should be surveyed to 1,500,000 people in the U. S. And again then with twice a year testing, if that was to be recommended, that would push the number of tests per year to 3,000,000 tests per year, so with again then a market potential maximum market potential of SEK 3,000,000,000. So that is how you should think about the sort of market sizes at play here.
Thank you very much.
Thank you. And as there are no further questions on the line, I'll hand back to our speakers for the closing comments.
Well, thank you very much for that. Obviously, August 3 was a huge day for IMONovia, an absolute pivotal milestone for IMONovia, every employee who has been working on The commercialization of IMREA CANKD, the development of IMREA CANKD and moving the clinical studies forward I'm feeling extremely proud for the achievement of the company. We're obviously also extremely aware of the fact that that this will make an enormous difference for people's lives. Individuals who have lived with pancreatic cancer in the family Now have a true opportunity to be surveyed for the increased risk of pancreatic cancer as they have. And we're extremely proud from IMUNAVIA side to be able to contribute in such a significant manner as we are in terms of helping identifying pancreatic cancer at earlier stages for this particular Nordic individuals and people with an elevated risk.
So Thank you so much for your interest in IMMANOVIA. Thank you so much for your continued support to IMMANOVIA. Thank you very much.