All right, moving on to our next presentation. Let's please give a warm welcome to the CEO of Oncocyte, Josh Riggs.
Hey guys, good afternoon. Thanks for making time for me today, so Oncocyte is an early commercial stage. Last time I did this, we were a development stage, but now we're an early commercial stage diagnostic company. We make products in both transplant and in oncology. We're going to focus mainly on our transplant technology today, and so if you're not terribly familiar with diagnostics, they're the tools that your doctors use to kind of like critical care choices, so in oncology, you know, what drug should I give? Is the drug working, and in transplant, you know, is the organ being attacked by the immune system, or is there a sign of graft damage, and so we're going to spend a little time talking about the different use cases we have here today for our technology and what markets we're entering.
So we're going to make a few forward-looking statements. Come on in, weather's fine. All right, so our goal is to take our novel technology and make sure as many people as possible have access to it. And so that means what we call democratizing access here so that we're not keeping that trapped at our central lab, but that we're putting that in a box, taking products through the FDA, through IVDR, and making sure that they're available for physicians sort of around the United States and around the world because we believe that local care is better care. And faster care winds up being better for the patient in general. And so you'll hear a lot of that theme in the next part of the conversation. But first, I'm hitting the wrong button here. Oh, there it goes. Introduce you to the team.
I'm over here on the left. It came out of the consulting space and then did a lot of business development work for the Oncocyte for the past four years, supported a lot of the acquisitions that the company has done, along with the partnerships that you'll have seen with us and some of the larger diagnostic companies out here. Dr. Schütz is the inventor of our core technologies. He invented the transplant assay that we're going to talk about today and also our blood-based therapy monitoring technology, which is DetermaCNI. Long history of publications in the space, so a decade or more of publishing on the technology that we're going to discuss today. Johnson Chang is a seasoned veteran of diagnostic products, so coming out of companies like Thermo Fisher and Cepheid, where he put over 20 products through various regulatory agencies.
He is really good at making sure all of the stuff comes together at the finish line so that the FDA can say yes to us. We very recently welcomed Andrea James to the team. She comes to us from Axon. She joined there when they were about $1 billion, rose up to $20 billion, and then before that, she was at Tesla. She has got a lot of experience with companies going through rapid growth phases. We are really excited to have her on the team. The launch market that we are going after with our first kitted product is in transplant testing, primarily for kidney. This is a relatively mature clinical market here in the United States today. You have got two major competitors, CareDx and Natera, who have done a fantastic job convincing the market that this type of testing is useful.
So what we do is donor-derived cell-free DNA testing, which is just a really big fancy way of saying as we count the DNA in your blood that's coming off the grafted organ. So if you've gotten a kidney transplant, the kidney cells, through the normal process of living and dying, will put DNA into the blood. Our technology can differentiate the DNA that comes from you and the DNA that comes from the grafted organ. And by counting that, that's useful information for your physician. So if that's a very high signal, it's above our clinical threshold, that's a sign that your graft is being damaged. And so one thing you're always worried about in a transplant scenario is that the immune system is going to recognize that there's a foreign body and that's going to start attacking it.
And then the doctors will need to intervene, provide different immunosuppressives or steroids to try and help fight that reaction from your body. The testing here, there's about 200,000-250,000 of these tests ordered each year in the United States, generating about $500 million in revenue. And it's largely happening at two labs. So you have a lab in Brisbane and I think a lab in San Mateo that get to do all of that. And what we want to do is make that testing accessible to the transplant centers that are creating the economic value but aren't participating in the economic value today. So you can imagine that there's about 100 transplant centers in the United States that do 80% of all of the transplant surgeries.
And they're sending thousands of tests a year to a couple of labs in California and not participating in any meaningful way in that revenue that's being generated there. By taking our product through the FDA and attaching the reimbursement rate that we already have with CMS to it, we create an opportunity for these hospitals to begin running the technology themselves and billing and creating that revenue for themselves. As we said, it's all highly concentrated. That's true in Europe as well. It's kind of a feature of the transplant testing market in that these tend to be relatively complicated surgeries. And so they tend to aggregate at high-end academic institutions, so places that you would expect to do transplant surgeries.
We found a really, really warm response from these top-end academic institutions who really would like to be able to ask their own questions of the technology, would like to be able to manage their patients a little bit more closely, and also keep control of that sample in-house. And so in our last quarter, we announced that we had signed a top five transplant center in Germany and a top five transplant center here in the United States. We're not releasing the names of those yet, but those publications will start coming out here in the near term. And I think this type of latent demand is what attracted Bio-Rad to the team. And so back in April, we announced a partnership with Bio-Rad to help globally commercialize this product. They're number two in my cap table. They've taken investment.
They maintained their investment in the last round that we did. And it gives us an opportunity when we go out to the market to look a heck of a lot bigger than we do on our own. So right now, we're about a $50 million market cap. It looks a little bit bigger when there's a $9 billion company standing behind me saying, "Hey, this thing is actually going to work." And so that was validating for our investors to see the multinational come in and support us. Their ex-COO is on our board, and he provides a lot of market feedback and guidance for us on that. So it's gone really well. We were at ATC earlier this year, which is the American Transplant Congress. It's the biggest congress that we have each year for the transplant community.
And we had the really good fortune of a New England Journal of Medicine article coming out just ahead of that conference where our technology was used to monitor for an anti-CD38 drug, felzartamab, that was being marketed by HI-Bio since acquired by Biogen. And it's the first drug in, I think, about 60 years that's actually shown the ability to manage what's called antibody-mediated rejection. And so one in five kidney transplant patients are going to experience antibody-mediated rejection. And the outcome is you lose the graft, you either have to be retransplanted, you go on dialysis, or you die. And so there's not a lot of really good outcomes here. And so when they saw 80% response rate in the treatment arm and 20% response rate in the non-treatment arm, it kind of lit a fire in the industry.
And our technology plays a critical role here because it's depleting out a key defense that your body has, which is the natural killer cells. And so you need to know when you've effectively managed that treatment. So you're monitoring and watching the donor-derived cell-free DNA levels come down. Once they're below the clinical threshold, you can pull the patient off of therapy. And then you need to continue to monitor them over time as you're waiting for the disease to come back. And so I think there's a really nice market expansion opportunity coming here for us. It's a nice tailwind along with the NOTA Act that's been passed by the Biden administration, which is increasing organ transplant access, which is going to increase the rate of transplantation in the United States by sort of having the centers use more marginal organs to transplant.
So instead of having completely pristine organs that are going in, you're going to wind up creating a higher risk pool of patients that are now getting transplanted. And that'll call for more monitoring with technology such as ours. And so really exciting times for us in the transplant market here in the United States and around the world. And we're very fortunate to be at the forefront of a lot of the developments here. The U.S. is probably growing at about 3% a year right now. It's a relatively mature market. But the rest of the world is growing much faster. It's growing at about a 9% rate year over year. We see that they're starting to catch up with the developments that have come out of the U.S. And because this technology came out of Germany, we've got a really strong footprint in Central Europe.
We've got really strong partners there who are helping us pull the technology into the marketplace. And I think we'll continue to expand and grow in Central Europe and beyond over the next year. When we look at what's the most important thing for Oncocyte to accomplish between now and the end of 2025, it's getting these centers up and running, making sure they're familiar with our technology, making sure they understand how it works, how to use it, so that when the IVD version of our product comes out, that we've got fertile ground to grow that business in. And so we've guided that we expect to have somewhere between 15 and 20 sites in the United States and between five and 10 in Europe to launch our IVD product into. Obviously, we'll start with IVD and then go IVDR, which is the European body.
We're guiding that each one of these centers should be a million-dollar ATM for us on an annualized basis. And so that's with very high margin recurring revenue. And we expect that we'll double installed base in the first year of launch and then add meaningfully to that in the year after that. The product itself is exceptionally simple. It's just two little strips with some reagents that have been dried down. It's room temperature stable. I can ship it all over the world. It costs me tens of dollars to manufacture. You can sell it for hundreds. So the margin is solid. And we expect that the centers themselves will be able to bill over $1,000 per assay. So there's plenty of margin to go around. There's plenty of opportunity for folks to improve care at their local center.
For example, one of the sites that we're working with is sending out over 5,000 samples a year to one of these labs in California. That's about $8 million-$10 million worth of billing that they're missing out on today that they'll have an opportunity to participate in in the future when they have our technology up and running. And so we're very excited to have the opportunity to come out and disrupt the transplant market and put this technology much closer to the patients and help improve the standard of care. It's a really, really simple business model, right? It's, "I'm just going to create a kit. I'm going to put it in a box, and I'm going to help people make money." So I don't know if there's much else to say about what we're doing on the transplant side.
I think we've got some oncology products that are at various stages in the funnel that are coming forward. We're waiting on a reimbursement decision for our DetermaIO assay, which is therapy selection. We're expecting probably by the end of next year. But why don't I go ahead and pause and see if you guys have any questions? Yes, sir. What tends to be the biggest catalyst for reception in the market for you? It's going to be IVD. So once we get through the FDA, I can attach my clinical claim to it and also attach my reimbursement rate.
What that will do is make it really easy for a center to answer the question, "Am I going to get paid?" And as you might imagine, that's the hurdle that most labs are going to have bringing up our technology is knowing, "Hey, am I actually going to get reimbursed for this?" If they know that they can plug and play and bill $1,500 per result, that's not an exact number. That's just a guesstimate at this point. It's really easy math for them to work out because they are already managing these patients on a day-to-day basis anyhow. They're just missing out on the high-value revenue opportunity. Yes, sir.
Why are they missing out? What would you say? Now, you say that just because of the condition. Very, very few things that you can do in two seconds and make $50 million.
It takes about eight hours. The problem here is IP. You've got about four IP estates that control access to donor-derived cell-free DNA testing. Three of them are on Illumina technology, which is kind of like they're the 800-pound gorilla in sequencing. Ours is on digital PCR. It's much easier to run, much faster to run. You don't need a PhD. If you've been trained in molecular, you've been trained on PCR. It makes it much easier for these labs to adopt. We have sample economics that really benefit the local lab that isn't running 50-100 samples a day. If you guys are familiar with the Illumina technology or you're not, they have what's called a flow cell. This is what you have to put in the instrument.
You load the reagents, the consumables, all that stuff on there. And then you turn it on. And every time you turn on that instrument, you're burning that $2,000 flow cell. And so if you're only putting one or two patients on there, the cost just is overwhelmingly prohibitive. Versus our technology, you have the same sample economics basically all the way down to one sample. And so if you have two or three patients show up in the morning, you can run those two or three patients that day and have an answer that afternoon for your doctor. With sequencing technology, you've got at least a 30-hour workflow to get that answer out. And that's assuming that you didn't have to wait and batch a whole bunch of samples together. Did I answer your question? Cool. Thanks. All right. Anything else?