Good morning, everybody, and welcome to ANGLE's interim results for the six months to 30th of June 2022. This has been a breakthrough half year for the company. We secured the first ever FDA clearance for a product to harvest cancer cells for subsequent analysis, and that followed a long-term effort over many years, so it was a tremendous outcome for us this half year. We're now moving ahead fast with the commercialization of Parsortix to transform cancer care. Cancer, of course, is a growing problem. No two cancers are the same and cancers change over time, so doctors need repeat biopsies to guide treatment, but tissue biopsies cannot be repeated. ANGLE has achieved a world breakthrough with the first ever FDA product clearance to allow a repeat biopsy of intact living cancer cells from a simple blood test.
This half year has delivered key progress. The FDA clearance, the establishment of a new high-growth pharma services business, and a deal with the largest urology clinics chain in the United States to progress prostate cancer. Momentum has continued into H2 with capital raised to strengthen our financial position. The release of a new low-cost way to utilize Parsortix in the pathology laboratories, known as Pap staining, which I'll explain a bit more later. The announcement today of, quite frankly, superb results in ovarian cancer. Financially, the company's cash position is solid. At the period end, thirtieth of June, we had GBP 20 million in cash. We had GBP 4.5 million due to us from R&D tax credits now received.
In July, we raised a further GBP 18.9 million net, giving us over GBP 40 million at that point, to provide us cash runway through to the mid-2024 timeframe. In terms of our financial results, obviously the cash position is the key point. Revenue is still at an establishment stage, and this period predated the FDA. Nevertheless, we saw a 40% increase in period-on-period revenues. Our margins dipped slightly to 62%, so still well over 60%, as we purposefully entered into some joint development contracts, in relation to our bespoke assay development. The beauty of that is we're making money whilst at the same time building out new assays to add to our menu. Commercialization is the key to success, and that is where all our efforts are being focused.
We're executing a clear and well-developed commercialization plan, which is targeting the adoption of our system across the entire industry and leveraging that industry to achieve success. We have three key business areas. Number one, pharma services. This is working with large-scale pharmaceutical companies and biopharma companies to support them in clinical trials. The great thing about this business is that every element, every step of this business is paid for by the pharma or biopharma company. They pay us to undertake clinical trials for them, and then ultimately, our aim is they will bring forward Parsortix as companion diagnostics to support their drugs and become the customer. Every element of that commercialization is a fully funded business model, paid for by the pharma. The second element of our business model is the med tech partnerships.
Because we have such a good system for recovering the sample for analysis, it makes absolute sense for us to work with those companies that already have diagnostic procedures for analyzing the sample. We can provide them the opportunity to repeat testing with patients because they can only get one tissue biopsy. If they work with ANGLE, they can use the Parsortix system to get repeat samples from blood for analysis with their systems. This is a great opportunity for ANGLE to leverage the sales channels of the big players in this market. We want to partner with all of the leading diagnostic companies around the world. I'm pleased to say that our discussions in relation to this part of our business model have accelerated significantly since FDA clearance, both in terms of the detailed discussions and the number of parties that we're in discussions with.
The third part of our business model is the product business. This is us directly selling our Parsortix system as a product to customers. Up until the FDA clearance, that has been focused on translational researchers who use it to do investigative research into cancer. Now, of course, we're expanding that into clinical use as well, having got the FDA clearance. Critically, one of the things that we're doing is extending our sales and distribution capability. I will explain that in more detail. Sorry, I missed out on a critical part of this slide. There are multiple drivers and factors affecting success here that we're focused on. There really are five key points needed for success. The first one is to get regulatory clearance. We've achieved that with the FDA clearance and with the European CE mark.
The second one is to demonstrate the value of analyzing this sample. We've achieved that with our ovarian cancer results announced today in a very difficult-to-diagnose cancer. The third one is to have clinical laboratories, of which we set up two, one in the United States and one in Europe, to act as accelerators and demonstrators. The fourth one is to do product development to show ways that you can use these cancer cells to benefit patients. We're actively promoting various different products, which I will describe shortly. The fifth and final one is to attain reimbursement codes. That is to get insurance companies and others who are funding healthcare to accept that they should pay for such a test. We've appointed a leading consulting firm in this area to drive forward our efforts to secure reimbursement codes for Parsortix.
The FDA clearance is well understood as being the gold standard. We were very, very pleased with the form of clearance that we got from the FDA, which was as an enabling platform. FDA has not limited the uses of these cells once they've been recovered. That's an unusual platform clearance, and it gives us the best possible basis for commercialization. Just to restate the obvious point, no other company in the world has achieved this success. Not only that, we're not aware of any company that's even started engaging with the FDA to secure this in any sensible fashion. It took us six and a half years. Since we've achieved this FDA product clearance, we've seen the first mover advantage coming through quite strongly.
We've had great interest from third parties, med tech companies, pharmaceutical companies, and even government. We're particularly pleased by discussions that we're having with large med tech companies, where there seems to be an increased sense of urgency to move forward with us. Our aim is to enable the entire industry. We don't want to remain a small company owning the technology. We want this technology in the hands of everybody. Our pharmaceutical business is our near-term major business opportunity. We successfully established this business over the last 12 months from a standing start. We offer something that pharma companies cannot get otherwise, which is the ability to do multiple tests on patients during their drug trials, assessing patient condition before they have the drug, during the time when they have the drug, and then afterwards, and sometimes multiple time points afterwards.
We successfully secured the first four significant customers for that business. One of them is a large-scale company with billion-dollar revenue and multiple different products. We signed the first contract with them worth $1.3 million, targeted revenues to ANGLE. They have already, despite the fact that it's still running, signed us up for a second contract worth up to $1.2 million. That is just a single customer, and they have numerous other projects that they can plug us into. We've also developed a new aspect to the pharma services business, again, which they cannot get elsewhere, which is what we call bespoke assay development. This means that the pharma can define the target that they're looking for on the cancer cell.
We can work to develop an assay paid for by them in terms of development, which we can use to look for that target. If it's an immune checkpoint inhibitor targeting, for example, the protein PD-L1, we've developed an assay that can look for PD-L1 on cancer cells. It can tell you how many cancer cells are present in the patient's blood and do they express the target. The first customer that bought into that has asked us to work on some proteins relating to DNA damage repair. I'm delighted to say today that we've successfully completed the assay development phase, meeting their requirements. The great thing about assay development is that the customer will then have to use it in their trials. They don't have an alternative supplier with that. We're giving them something that meets their requirements precisely.
Our pipeline in pharmaceutical services has grown significantly since FDA clearance. We now have over 20 new customers in discussions with us, majority of which are looking for the bespoke assay development. The bespoke assay development maybe make us GBP 100 thousand, or so in terms of that assay development paid for, research and development. This is also a very clever way of deploying our R&D activity and turning it from being an overhead into being a profit-generating asset. Once they've done that, we're likely to get several million dollars of revenues relating to the clinical trials application of that bespoke assay. Ultimately, if it gets all the way through to the market, that bespoke assay may well become a companion diagnostic, used to test patients to assess whether they should be given the drug.
This is a whole flow-through methodology whereby third parties, large third parties, pay for development of assays, which will make ANGLE shareholders a great deal of money in the future. Of the 20 customers that we're in discussions with, there's a whole range of different types of customer. As I said, most are interested in bespoke assays. These include three household name pharma companies that we're in discussions with. We're hopeful that some of them will come through. The pharma services business is a very attractive, high-growth, high-margin business in which ANGLE is uniquely positioned. The scale of that opportunity is illustrated by this slide. This just takes data from the clinicaltrials.gov website of the number of studies that are in process at the moment.
What you can see in the first column there, for example, breast cancer, there are over 950 clinical trial studies in progress according to clinicaltrials.gov, recruiting 247,000 patients. Now, if you think about minimum of three time points for every patient and a charge per blood sample of $1,000 and potentially more if we do detailed molecular analysis, that's a very large market. We estimate that just these four cancers, and we're not limiting our activity to these four cancers, the market opportunity is over $2 billion.
We're very, very well-positioned, offering something that the pharma can't get, longitudinal monitoring before, during, and after in a large-scale market opportunity. In terms of our product business, we are ramping up our sales and distribution efforts to sell the Parsortix product and consumables associated with it. We're doing that by building out sales and distribution channels with distributors who are expert in oncology and can provide engineering service and maintenance support to the product. We're seeking and this is a core underlying theme of everything that ANGLE's doing. We're seeking to leverage third parties to get maximum impact. As you can see from the chart, we've already got discussions going in a very wide spread geographical area, way outside anything that we could cover ourselves with a direct sales force.
These distributors are being tasked to sell the Parsortix system into clinical labs. These have to be fairly advanced clinical labs at this point who are able to do laboratory developed test development. In other words, they take the Parsortix system, they get the best sample out of that, and then they work out what to do with it themselves. They're also going to sell a range of new ANGLE products that are being developed down the same channel. I'll tell you little bit about some of the products that are under development. The first one is the one I mentioned at the beginning, Pap staining. We've already announced that we've launched this.
What it is, it's a really super simple methodology where we take established Pap staining approaches, which is used for dealing with cervical smears, and we basically deploy that on, onto the cancer cells. It's a simple way for the pathologist to look at the cancer cells. That was launched at the American Society for Clinical Pathology meeting. That one's already been launched. We've got three other immunofluorescent assays, which is using a technique for staining the cells for particular facets. The first one is our, well, our sort of standard offering, Portrait+, which enables the user to identify and look at different types of cancer cells, and thereby they can enumerate those cells at different time points.
The second one is Portrait+ PD-L1, which adds on top of the standard assay, the ability to look for the PD-L1 immune checkpoint inhibitor. The third one is the Portrait+ DNA damage that I mentioned that we've developed for a customer. Again, just to clarify that, the customer paid for this because they wanted it. The terms of the agreement are that we own it thereafter. We are now offering it to other customers. It's a very good way of building out our menu, funded by third parties. Then the final area which is under development is called Landscape+, and that's focused on molecular solutions.
The key thing here is that we're working to provide the ability for our customers to measure DNA and RNA cancer gene panels, on the cancer cells that come out of the Parsortix. That is one to watch out for. We're working very hard on getting that in place. Once we have it, we believe it will be extremely attractive to our pharma customers, which will increase the level of engagement from pharma and also significantly increase the pricing that we can charge pharma, because it's very well established that they will pay a lot of money for molecular assays. We also think it will be a trigger for the expansion of clinical sales of the product because it is what our customer base actually wants to do, is the molecular analysis.
I've said most of the things here about this Pap staining solution. You can see the examples of some of these very rogue-looking cancer cells that are found in patient blood using Parsortix. Just a reminder, these cells are very, very rare. There may be one cancer cell in a billion blood cells. You can't just look at them without being able to concentrate them using the Parsortix first. The Pap staining is a way of taking the output of Parsortix very simply at low cost, staining it in a manner that the pathologists are very, very familiar with. That's a standard approach for cervical smears. They can look at it underneath the microscope.
Now, we see the Pap staining approach, because it's low cost and it's very easy to do, as a Trojan horse to get our system into the labs. Many companies come up with new ways of doing things, and they hit resistance and conservatism from incumbents in the clinical world because they don't like changing what they're doing. Pathologists certainly don't like being told that they're now obsolete. We're doing the exact opposite. We're giving the pathologists more power, more important things that they can do, and they can repeat their testing. That's why we see it as a very important Trojan horse in the way that we go forward. I said at the outset that clinical studies to demonstrate the value of this BEST sample coming out of Parsortix is absolutely critical.
That is why I'm absolutely delighted with the ovarian cancer results that have been announced today. These are best-in-class results. They outperform every other technology, both in the market and under development, that we're aware of, very significantly. They have the potential to reduce the false positives, which is a massive problem in all kinds of cancer diagnosis. False positives mean over-treatment, anxiety for the patient, and other problems. You do not want false positives. In ovarian cancer, the false positive rate is very high. Up to 80% of positives are false positives. We've shown in the direct matched pairs samples, so the exact same patients, we showed that we could reduce the false positives by over 50% and also reduce the false negatives by 50%.
I see this as a massive demonstration of the power of the BEST sample coming from Parsortix. It is the exact opposite of GIGO. We talk about GIGO, garbage in equals garbage out. If you start with a bad sample, you're not gonna get a good result. Alternative assays start with something called CA-125. It is a free-floating protein in the blood of patients. It is absolutely true that the CA-125 gets upregulated for patients with ovarian cancer. But the problem is, it also gets upregulated for other things as well. It doesn't matter how well you measure it is a bad input. It is garbage in, so you get garbage out.
If you start with a good sample, in fact the best sample, which is living intact cancer cells coming from the patient blood in real time, then you have a good chance to do something good. That's why we think that this is an important exemplar. We've taken an extremely difficult cancer, ovarian cancer, very well known as being difficult to diagnose. Cannot do tissue biopsy on it because it's invasive. Once you start doing a tissue biopsy, you might as well do the surgery. We've done it in a real-world population. This is not some fake study like you see all the time in the Daily Mail of, oh, we had some healthies, and we had some cancers, and we could detect them. This is a real-world sample.
Every single patient of 144 patients had an abnormal pelvic mass. Not one of them was healthy. They all had to have surgery. The question is, did they have cancer or did they not have cancer? Because if they had cancer, they needed to be treated differently with a different surgeon. They maybe needed neoadjuvant chemotherapy. We showed even in that very difficult-to-diagnose cancer, with all the patients being sick, we could discriminate between those who had a pelvic mass which was benign and those who had a pelvic mass which was malignant, despite them having broadly the same symptoms. We see that as a very, very important exemplar of the strength of the Parsortix BEST sample.
We also see it as a very good example of the strength of molecular analysis, because we use molecular analysis to assess the presence of these cancer cells of the Parsortix harvest. It therefore has a very wide read across to multiple different cancers and multiple different applications. I would just reemphasize, this is real world data, and it far outperforms other things coming out from other places. We're delighted with the ovarian cancer results announced today. We're moving forward. We started with breast, we've now got ovarian, and we're moving into prostate. During the half year, we cut a deal with the biggest chain of urology clinics in the United States, called Solaris Health.
These folks want a test using Parsortix in order to help their patients assess whether they have prostate cancer via a simple blood test, and secondly, to assess whether it's clinically significant. They have over 700,000 patients every year who would like such a test. I think this is smart commercial approach by ANGLE. We've started with the commercialization before we do the study, in this case. We have a partner that wants to deploy the test. They want to market this to their patients. They're also gonna help us fast-track the prostate cancer studies, clinical studies that we're doing, because they have access through to a lot of patients. We're very, very pleased with that, and it opens up the potential for a very large market.
We're on track to complete the necessary studies for that by the end of next year. I'm gonna get to the sort of summary position now. We are very focused on near-term strategic and commercial imperatives. We're making strong progress and key milestones are being delivered. We've launched our FDA-cleared and CE mark system in the United States and the rest of the world, and we're working to secure leading reference clinical laboratories as reference customers. Our pharma services business is now well established, and it's growing out with additional customers and repeat business from the existing customers. The corporate partnership, corporate deals for med tech companies, pharma, clinical labs, we have numerous discussions ongoing, and we're hopeful that they're gonna move forward rapidly in the future.
We're working to secure the accreditation of our two clinical labs, which are branded now as Oncodux Laboratories. We've got a plan, a four-point plan, to deliver future growth. The first one is building out that distributor network that I mentioned as a channel for our products. The second one is to finalize the different products that I identified as content to put down that channel. The third one is to complete additional clinical studies, next slot being in prostate cancer, to demonstrate the utility of what we have to offer and prove out the value of the BEST sample coming from Parsortix. It's worth noting as a sub-bullet there that we don't have to rely just on ANGLE to fund these important clinical studies.
We know of multiple studies being funded by third-party clinical labs because they want to see the benefit of using Parsortix. Two notable ones are the Lianidou Lab in Europe, which is working on a PD-L1 immunotherapy study. There is an active study right now, working with cancer patients, measuring using Parsortix as the front end, the PD-L1 status of patients, and assessing whether they respond to immunotherapies, totally funded by one of our customers. If that, and that's due to read out somewhere around the end of this year. If that comes through positive, it's a massive uptick for ANGLE, and it's cost us nothing. That's what I mean about a leveraged strategy. We want the industry to adopt and take this forward.
We're trying to do the early work to get things moving, but then others need to pick up the baton and run with it. Similarly, the Aceto Lab in Switzerland, they're working on the cluster buster drugs, which were identified as the ability to disaggregate circulating tumor cell clusters identified by Parsortix. It's fundamentally dependent on Parsortix, and they are running the first-in-human trials for these cluster buster drugs in breast cancer. Again, expected to read out around the end of the year or beginning of next year. Would have a major read across to ANGLE, fully funded by third parties, not by ANGLE. The fourth key factor here is getting payment. Payment for these services. You need to get the health companies and insurance companies behind the payment for the use of Parsortix.
We're working on that as well, and we've appointed consultants to help drive that forward. To summarize, despite challenging stock markets, CelLBxHealth is very well-funded and is in a strong position to drive forward our commercialization. We've got first mover in a very large market, with the only FDA clearance being a breakthrough, and we're now in a position to capitalize on this strength, with multiple corporate partnerships with leading med tech and pharma companies in discussion. Our pharma business is beginning to accelerate now, and we believe that we're in a very strong place. This is all driven by the fact that we have a product-led solution. Because we have a product, we can sell it to third parties. We're not dependent on doing everything ourselves. We're enabling the industry to go forward.
We've got multiple potential catalysts over the coming months, and we see this as very exciting times as momentum is building within the company. Thank you everybody for your attention. I'm gonna go and sit down, and I look forward to taking questions from the analysts. Thank you. Who wants to go first? I should say that Ian Griffiths, the CFO, is with me, and you'll probably hear him speak next, depending on what the question is.
Thanks a lot for the presentation, Andrew. First of all, on the go-to-market strategy for ovarian cancer testing, could you please remind us the steps required, and expected timeline on each, to start offering this to gynecologists, let's say, or hospitals?
Yes, I can. There's multiple different commercialization routes for the ovarian cancer assay. We are still doing actually some further analysis of samples, and some further statistical analysis, which may strengthen the results, further. We can consider offering the ability to run this test to a third-party clinical lab. We can also install it in our clinical lab, and we could find a cancer center, a bit like Solaris Health in prostate cancer to offer it to their patients. We could also work with a downstream partner who might want to promote this. We can also consider whether we want to have a service-led approach or a product-led approach. There's a number of factors.
Now that we've got these excellent results, we're considering those, and we're working on the detailed plan for commercialization. We're expecting to be able to essentially announce those plans by the end of the year at the latest.
All very clear. One of your med tech partnerships for downstream analysis, post extraction using Parsortix. I mean, now that you've been through several more detailed discussions here with potential partners, could you give us some color on what the economics of such partnership would look like? Also a feeling of what would be the first few steps after you announce these partnerships.
Yes. I can tell you what our target is. I can't tell you exactly what we're in discussions about. Our target is to engage with a very large company or companies that have downstream capability to analyze the cells to explain to them the opportunity to get repeat revenues from their existing installed base. At the moment, they can only do one test for each patient because you can only do a tissue biopsy once. Now with Parsortix, they could do repeats, so maybe three or four additional tests. And then agree to run necessary studies to demonstrate clinical evidence, and then potentially go and get an FDA clearance for the combined product. And then offer it via the sales and distribution channel of the partner.
In terms of the commercial basis, we are expecting the partner to get access to sell that combined product, and we will be paid for provision of the Parsortix consumables and the Parsortix instruments. In exchange for that, we expect them to pay the development process. We expect them to fund the clinical studies and fund other aspects. This commercialization approach is a very important part of our strategy because it then makes it very similar to pharma, where the med tech company is paying the cost of development, and we benefit at the end. This is an opportunity we can do because we have a product, not a centralized lab with a service. We expect to use it to drive forward commercialization at third-party cost.
That's critical for us because we don't want to build a massive direct sales team. We want to leverage existing sales teams where they are. As Andrew mentioned, they're doing a solid tissue analysis already. We're able to expand the med tech or pharma's market by offering those repeat tests, but we still use their sales and distribution channel. It's win-win for both of us.
Great. Thank you. Last one on the Landscape NGS panels. Is it just you investing in creating these panels, or is it your provider of the sequencing platform as well helping you develop that? What is the timeline that you give us an estimate on when you're planning to sort of take this to the market?
We've developed a very innovative ovarian cancer panel in-house. Going forward, what we have is multiple conversations with third-party companies who've already developed panels. Often they develop these panels either for tissue or for circulating tumor DNA. What we're doing is we're engaging with them and working to collaborate to show that those same panels or maybe slightly modified could be used with Parsortix. The great thing about that is it's all about leverage. Where there are customers who bought NGS systems, they've spent millions already. They want to run these cancer gene panels, but they're stuck. Where do they get the sample from? They get tissue, they maybe do ctDNA, but then they can't get the RNA, they can't get actual cells.
If they partner with us, and sell Parsortix in, then their customers can do repeat tests on their equipment.
Well, the other key thing as well is with us, is they can do both DNA and RNA.
Mm-hmm.
All very clear. Thank you.
Thank you. You've mentioned, and clearly so, the multiple commercial streams that you have available to you. Can I ask, some of them seem to have a shorter lead time, others a longer lead time. Can you give us a feel for how these revenues will land over, say, the next two, three, five, 10 years?
Sure. As Andrew mentioned, with the LDT and FDA-cleared product type things, you've got to go through the process of getting a reimbursement code. Initially, you'd have a soft launch with private pay. The revenues would be very modest before you've got the reimbursement code in place that then allows those revenues to build. That's why we've got the focus on the nearer term revenue opportunities as well. We kind of run these in parallel, but recognizing that clinical sales has got a longer timeline to get the revenues in. The focus is therefore very strongly on the nearer term as well. That is then the existing translational research sales, so that's just it builds our business. Obviously, the FDA-cleared product gives us credibility.
We're seeing with tenders, on the criteria, we're in a much stronger position, higher conversion rate. Also, we don't have to go through the sort of longer evaluation period that we did with the earlier sales. We're seeing that side of things accelerate. The critical bit that we've been building into is the pharma services. That's the one where, obviously the pharma do have money. You don't need to go through reimbursement. You're negotiating with them directly. Depending on what type of analysis is being done, those tests are typically between $1,000 and $2,000. If it's in a clinical trial setting, that's $1,000-$2,000 per sample processed.
Most of these clinical trials are gonna have multiple time points that might be sort of pre, before, during and after, or up to seven. We've got in some existing client samples over a multi-year project. Building out pharma also gives us that medium-term visibility. It's very much, it's the pharma, both the assay development and the clinical trials. As Andrew mentioned, the assay development is the early stage where we're very strongly differentiated, but they're smaller contracts. We're building that up. It's the discussions with the large med tech companies doing paid development work to join Parsortix with their downstream analysis. Again, that nearer term revenue.
The other bit that the FDA clearance has allowed us to do is about placing the PC1 places on board, but about getting the PC1 sold into the different parts in the world by engaging with the distributors who are able to now place PC1 directly into hospitals, oncology labs and so forth. That's why we're taking that approach. They're the three nearer ones. But as I said, as we're running the clinical sales side of things, the LDT and the FDA parallel with this, but those revenues will kick in later.
Can I pick up on one of your points? You say, each test will cost around $1,000. How much of that would actually attribute to your sales?
Okay. It will vary. The margins for us will be between 60% and 95%. But at the moment, we don't have an in-house NGS capability, so we have to send that out if it's being done. Obviously, we're giving up some of the margin that pushes us to the lower side. We'll have a higher value test towards the $2,000 'cause it involves NGS, but we get a lower margin on it because we're not doing it all in-house. Whereas some of the other things, if it's a PCR-based test, we've got that in-house. If it's immunostaining, we've got that in-house, so we can get a higher margin, but the test value is probably gonna be lower just looking at a specific smaller number of genes. It will vary between the two.
You know, we'll be on a case-by-case basis on what's the appropriate margin.
Thank you, Ian.
Thanks.
Just following on slightly from that last point. In terms of the pharma services and the, you know, client-led development process, would you expect to see the same kind of pricing model for assays sold, developed via that route or-
I can't quite hear you. I'm sorry.
Is this any better? There we go. Great. In terms of the pharma services-led development model, would you expect to see the same kind of pricing as LDTs or would that be more royalty-based?
I can answer that. The LDTs will be priced based on the value to the market. You can add as well, Ian. The ovarian. There's a less good test that's currently reimbursed at $897. That gives you a bit of an indication on that. Do you want to add to that?
Yeah. What we've seen is that some of the existing ctDNA panel is more typically in the region of $3,000-$5,000 is the reimbursement code. Obviously, they're looking at a lot more information. When you're looking at a smaller number of genes or serum markers, whatever it tends to be at the lower side on the reimbursement. What we have to do, and this is again back to the point of getting the reimbursement code takes time before you get the payment on there. We have to make the health economics case to justify what is an appropriate reimbursement code. That's, as I said, with a more accurate test, you can justify a higher level of reimbursement. Also, there's other features that could be done.
With the ovarian, you know, what we're seeing is current treatments moving more to a neoadjuvant side of it as well. Because of the data we're getting, we can help guide the oncologist on what is the appropriate treatment there as well. Again, that leads to higher value. We have to go through that process of making the argument of what is the appropriate reimbursement code. The other thing is, you know, as I said, what we're tending to see is that they're in that range more the $3,000-$5,000 if it's panel. Sort of the $1,000-$2,000 if it's a low number of genes. We have seen some exceptionally high ones at $7,500 is the highest one I've seen, but that's very unusual.
There's also read-across by the way, in the metastatic breast area where we've got an FDA clearance. It's in the national cancer guidelines in the United States that a patient should have a tissue biopsy of the metastatic site. This is the secondary site. That's not possible in a lot of cases 'cause patients are too sick or the tumor's inaccessible. Where it is possible, the average cost of the surgery involved is $16,000, and we're offering a blood test alternative. Clearly that is a very good read-across for health economic argument.
That's $16,000 for the biopsy surgery?
$16,000 is for the biopsy of the metastatic site.
Metastatic site.
Like liver or lung, whatever.
Lung or bone. Yeah. That's an average price, obviously. There's multiple metastatic sites.
Fair enough. You'd be aiming for gapfill in this case, for the pricing codes for your LDTs?
Yeah, sorry.
Would you be aiming for gapfill then in that case, in terms of your pricing codes? Is that for all the LDTs or it would be a mix depending on what's available?
No, that's under consideration at the moment. Probably what we're gonna go for is a CPT Category I code. It's not yet clear and we've got experts working on that at the moment.
Sure. Thank you very much.
Thank you.
Thank you.
I should say the reason it's not clear is it's just like the De Novo FDA clearance. It's the first time anyone's done this, so different approach.
Just on the you talked about the products development being a lot of that third party funded and then retaining the IP on them. On the bespoke assay analysis you talked about, is that the same situation there or is the big pharma gonna wanna keep the IP on that?
There's lots of different downstream techniques. So the methodology that we use for the ovarian cancer is an in-house proprietary molecular platform, but where we've got patents across the world. We are however very keen to use industry-standard downstream techniques. We, for example, Illumina is extremely well established sequencing platform. If we can run our Parsortix sample on the Illumina easily, it's much easier to get adoption and obviously Illumina make all the money from the Illumina side, but we would make the money from the Parsortix side. That's the way we think about it. We don't need to own everything. The Pap staining, stains and stuff is all industry standard. There's no intellectual property on that.
The immunofluorescence assays that we're bringing out, however, we are gonna have reagent kits. We're working on, for example, lyophilization of the reagents so that they will be shipped in powder form rather than as liquids. We've done the optimization. We have the secret sauce recipe of the best way to combine the antibodies, etc. There is. We've also got a methodology for getting the cells, called a CellKeep Slide, getting the cells down onto a microscope slide, which is also an additional intellectual property area where we've lodged patents. Where it makes sense to do it. We are going out for additional intellectual property and building out our barrier essentially from that point of view. Equally we do want to use standard downstream platforms.
I do. Yeah, I was gonna say I'd probably add one other thing is on the assay development side of things, we're taking a sort of a co-development approach with a lot of companies. So they get a sort of a cheaper initial development price that we also then have the know-how and associated IP that we can add that to our menu. That makes our offering more attractive to other pharma customers as we build out that menu.
Yeah. That's specifically for the pharma bespoke assay development. They own their data, but we own all the methodology and we're allowed to use it. Specifically, we're allowed to use it for other customers as widely as we want.
Okay, thanks.