Thank you all for joining us today. I'm John Hanna, the President and Chief Executive Officer of CareDx. Briefly, I want to say we will be making forward-looking statements in the presentation today. Please refer to our Safe Harbor statement in the presentation deck that's posted on our website. CareDx has put in place an experienced leadership team to drive profitable growth. We have roughly 650 employees globally in the company, 180 focused on commercial execution of our products in the marketplace. We have 110 scientists and researchers that are building the next innovations in transplantation, and 80 software programmers that are focused on both the infrastructure of software inside of the company to service our lab testing customers, plus our digital products that we deploy globally to support transplant centers.
The transplant market is a $50 billion market in the U.S. alone, from organ procurement through the transplant procedure and post-care follow-up of those patients. In the U.S., we transplant roughly 46,000 organs a year. That means we spend a little over $1 million on average per organ transplanted in the country. At CareDx, we performed approximately one million rejection monitoring tests to support patients post-transplantation. About 70% of the transplant centers use one or more of our digital solutions. We perform or distribute about 200,000 HLA testing kits annually, and we filled 150,000 prescriptions through our transplant pharmacy over the past 12 months. Just a brief highlight of our Q3 financials: we did $82.9 million in revenue, a 23% increase year-over-year. Our testing volume was 44,600, about a 16% growth rate year-over-year. Our gross margins are approaching 70%.
We were $6.9 million adjusted EBITDA positive on the quarter, and we closed the quarter with a cash balance of $241 million and no debt. Q3 was the fifth consecutive quarter of testing services growth for the company since the second quarter of 2023, and we adjusted our 2024 full year guidance to the range of $327 million-$331 million. That implies that we're going to do roughly 30% year-over-year growth for the fourth quarter. I'm sorry, volume growth in the mid-teens and implied revenue growth of 30% year-over-year for the fourth quarter. Our revenue growth is outpacing volume driven by our ASP appreciation, which has gone up significantly in 2024, and no changes to our Medicare coverage. We anticipate our products business to grow in the high teens and our patient and digital business to grow in the mid-teens.
We think we'll close the year at 69% gross margin and $18 million-$22 million in adjusted EBITDA positivity. We've outlined four building blocks of growth for the business going forward, the first being transplant volume growth or secular market growth that's being driven by two factors. The first is government efforts to increase the volume of transplantation in the market. Last week, the administration finalized the IOTA program, the Increasing Organ Transplant Access program for kidney transplantation, to incentivize centers to perform more transplants and use more of the available organs in the marketplace. In addition, we see technological advances such as perfusion being used increasingly in the market, which are driving growth of organ utilization and transplant across the United States, and so roughly, we've forecasted a mid-single-digit growth in the secular market of transplant volume over the next three years.
We're currently seeing in 2023 about 11% in heart, 12% in kidney, and 7% in kidney. We have a synergistic portfolio of products that we offer to transplant centers, which is the second driver of our growth. It's customer adoption of our service. We start on the left-hand side with lab products, where we offer customers HLA typing kits, lab management software, and waitlist management software to help them get more patients access to organs that are on their waitlist. Within the transplant center, we offer a transplant EMR, quality reporting software, and staff augmentation services. If they need help with their quality reporting or management of their programs, we will deploy people into the transplant center to support them.
And then post-transplant in the graft health area, we offer diagnostic solutions, including remote patient monitoring, graft health assessment, and tissue diagnosis with our HistoMap product that will launch in 2025. This solution set is important because we find that when centers utilize three or more of our digital solutions, the capture rate or the proportion of patients that they transplant that get on our testing services is 50% greater than centers that use three or fewer of our digital solutions. And the overall revenue generated in those centers is two times the revenue to CareDx generated in centers that use less than 3% of our digital solutions. So we're using these solutions, these digital solutions, as the lead as we go into accounts to support them in their overall program growth. And the downstream effect is more adoption of our testing services and growth and revenue for the company.
The third driver is patient adherence. Within institutions that we work in, they function on a protocolized basis. In heart, lung, and kidney, they implement protocols that typically follow the protocols that were adopted in the clinical validation studies of our products. In heart and lung, that's 11 tests in the first year, four in the second, and four in the third. In kidney, it's seven tests in the first year, four in the second, and four in the third. In totality, if you looked over the first three years of patient testing, in kidney, you would expect 15 tests over that three-year period. In heart, because we have a HeartCare product, which is both AlloSure Heart and AlloMap Heart, it's 38 tests. In lung, it would be 20 tests.
But in reality, we see an adoption or adherence to those protocols that is roughly 50% of what would be expected. And so as an organization, we're very focused on driving further adherence to the protocol that the center already has in place to drive our own growth in the market. And then the fourth is additional pipeline products. In 2025, we're going to be launching two extensions to existing products, including AlloSure for simultaneous pancreas and kidney transplantation, and then AlloSure Heart for pediatric patients. And so those validations are complete, and we're going to be launching those extensions early in 2025. And then our product pipeline of new product launches is focused today exclusively in the kidney market.
So for kidney patients, we're launching AlloMap Kidney, which is a product that's a gene expression classifier to measure the level of immune activity in patients that have had a kidney transplantation that is complementary to AlloSure Kidney, which measures organ damage. We're launching HistoMap, which is a tissue-based assay to subclassify biopsy samples from patients that are in active rejection into ABMR, TCMR, or mixed rejection. And then UroMap Kidney, likely in 2026, which is a urine-based product that looks at patients that are suspected of rejection but could have a viral infection called BKV nephropathy. And this is a very critical condition because patients that have a viral infection should be dosed down on immune suppression so their immune system can attack the virus, whereas if they have rejection, you increase immune suppression.
If the patient has the viral infection, you increase immune suppression medication; the patient could die of the virus, and so this is a really critical decision point in the care of those patients, and there's a lot of interest in us making this UroMap product available in the marketplace. As we go forward, beyond driving our growth through volume, the other thing we're doing is focused on establishing additional evidence to drive reimbursement of our products and increase our average sales price. When we look at our product portfolio, AlloMap Heart, which is our product that's been on the market since 2004 and has been covered by Medicare since 2006, roughly 90% of the claims that we submit are covered by Medicare and private payers because that product is well established with robust evidence over the past 20 years developed.
In AlloSure Heart, roughly 40% of the tests that we submit are covered by payers, and that received Medicare coverage in the year 2020 after its 2018 launch. An example here is a recent coverage win that we had with AlloSure Heart, where the Blue Cross Blue Shield Federal Employee Program covered AlloSure Heart on the basis of the SHORE publication that came out in Q2 of 2025, which was a multicenter study of 2,500 patients with at least two years of follow-up, showing that the use of HeartCare when both tests were positive had a higher yield of rejection on biopsy than when either one test was positive or both tests were negative, and so it was definitely improving the care of patients and increasing the detection of rejection.
In kidney, we published in 2025, or independently published in 2025, was a Nature Medicine publication of about 2,800 patients looking at the utilization of AlloSure Kidney and the detection of subclinical rejection in those patients well ahead of biopsy, upwards of five months in advance of biopsy-detected rejection, and it showed that these patients can be identified, treated effectively, and managed going forward to salvage that graft. Roughly 60% of the claims we submit for AlloSure Kidney are covered by Medicare and commercial payers, and then in AlloSure Lung, which is the test that was most recently launched in 2021 and is earlier in its evidentiary journey, roughly 30% of the claims we submit are covered, and a second case here with Highmark Blue Cross Blue Shield recently issued a positive coverage for AlloSure Kidney in the third quarter.
This coverage policy was based on the findings in the Nature Medicine publication around the early detection of subclinical rejection in that population using surveillance testing. We're going to continue to build the evidence for these assays. In particular, we talked about the SHORE publication in Heart. This is one of many publications we expect to come from this study. It was an interim readout of two years of follow-up. This study is following all heart patients for five years in 2,700 patients at 67 sites, and so we expect that we'll be publishing five-year survival data. We've used this patient population to validate the pediatric use of AlloSure Heart, and we're evaluating directing therapeutic treatment in this study, so how are they changing their therapeutic management of patients on the basis of HeartCare results? In kidney, we have the KOAR and OKRA studies.
This is 3,600 patients with three years of follow-up at 56 sites. Initially, the KOAR publication will look at procedure decision-making, so biopsy decision-making in those patients, and then the treatment of subclinical rejection and three-year overall survival when utilizing AlloSure testing versus not using testing in a control group. And then lastly, the ALAMO study in lung, which is 500 patients with five years of follow-up at 19 sites. We're looking at surveillance outcome, detection of subclinical rejection, and all transplant coverage. So effectively, how are they managing these patients if they have subsequent transplants even beyond lung? So an important set of studies here where we're really building that evidence base to drive reimbursement for the products long-term.
We highlighted in our investor day in October our objectives, which are to exit 2027 with $500 million in revenue, which is a 15% growth rate over the next three-year period, greater than 70% gross margins on the business. We anticipate that in 2027, we'll do 20% positive adjusted EBITDA, and we'll add an incremental $100 million in cash to the balance sheet over that period. We intend to use those funds for capital allocation in the form of mergers and acquisitions. So we're looking at additional solutions that we can bring to transplant centers in order to increase the portfolio of products and services that we offer to those centers. We will continue to invest in the core business where we see an outsized return.
And if we don't see outsized returns for investing in the core, then we'll turn toward share buybacks with that cash that we have on the balance sheet. Going beyond solid organ transplant, the next wave of growth for the company will be driven by testing for stem cell therapies and stem cell transplantation. Today, there are 5,600 clinical trials globally looking at stem cell and stem cell therapy utilization and CAR-T therapy. 70% of these trials are in blood-based cancers, typically in hematology, oncology, leukemia, lymphoma, etc. About 10% in autoimmune disorders, which is a very large market, but there's been some early data suggesting that the utilization of stem cell therapy and autoimmune can be incredibly impactful. And then there's a subset of studies looking at indications like diabetes and viral infections.
Today, there are roughly 220 centers in the United States that are accredited to do hematopoietic stem cell transplantation or bone marrow transplantation. These are the same centers that we target today that do solid organ transplantation, so this is a product set geared at the same market that we're already addressing. 148 of those are accredited to do cell therapy such as CAR-T or TCR-T, NK therapies. We have two products to address this market. The first is a product called AlloCell, and AlloCell is a product that looks at the initial uptake and persistence of that new immune system in the patient body, and this is a very critical period in the initial injection of the new immune system into the patient body where you want to see that peak as it expands in the body, and then it troughs down and levels off.
The second product is called AlloHeme, which is more of a monitoring assay for cancer relapse. And so in this product specifically, we're looking at patients that are in the blood-based cancer space for which we are monitoring for recurrence of that cancer by looking at the cells in that patient and trying to detect relapse based on changes in the immune graft system of the patient. So in closing, we're activating our strategy by putting the right team in place. We've identified the right market opportunities for growth in transplantation, and we're launching innovative solutions to address unmet needs for patients and clinicians in the transplant market. And so with that, thank you very much, and I'll take any questions. Please.
How are you tracking towards your 15% growth rate?
It is. So at our investor day, we said that the 15% growth rate includes 1% growth based on new products. As you saw, the majority of those products are either extensions of existing products or they're new products to support the growth of existing AlloSure Kidney business in the marketplace.
Okay. Thank you very much.
All right. Good morning. Thanks for everyone for joining us. Happy to have with us here today President and CEO of Inogen for our next presentation, Kevin Smith. I'll turn it over to you, Kevin. Thanks for being here.
Hey, thank you very much. All right. I also have with me here today Mike Bourque, who's our Chief Financial Officer. And before we open it up for questions, I'll just give you a little bit of an overview on Inogen if anybody is not familiar with our story. We're a global leader in portable oxygen therapy. Our aim is to improve lives through respiratory care. When you look at the overarching disease states that we're looking to tackle here, it's COPD. It's chronic obstructive pulmonary disease affected.