I guess on the second day of the William Blair Growth Stock Conference here in Chicago. If you do not know me, I am Andrew Brackman. I am the diagnostics analyst here at William Blair that covers Biodesix. Today we are joined by the CEO, Scott Hutton, and CFO, Robin Harper Cowie. Format for today will be a presentation, formal presentation in here, and then we will go to the breakout room immediately after. Lastly, I am required to tell you that for a full list of research disclosures, please visit williamblair.com. With that, I will turn it over to Scott. Thanks, Scott.
Thank you, Andrew. Thank you, William Blair. It's always a great opportunity to be here, and we appreciate this. As Andrew said, Scott Hutton, I'm the CEO of Biodesix. I'm joined by my colleague, Robin Harper Cowie, the CFO. If you're not familiar with Biodesix, I'll give you a little bit of a background. We're a leading diagnostics company focused in lung health. Our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical need. You can see we envision a world where patient disease is conquered with the guidance of personalized diagnostics. We generate revenue from two distinct segments of the business. One is our lung diagnostic test, and we'll go into great detail of each of these. Here we have five on-market tests, all with Medicare coverage.
The complementary side of the business is our development services, or more traditionally referred to as biopharmaceutical services. We have expanded it because we are working with a number of life science partners and academic research institutions also. We currently have the largest commercial sales force focused on pulmonology. We recently disclosed that we will plan on having 95 sales reps in the United States by the end of the year. We have over 300 publications and presentations, and we are proud to state that we have always been focused on a multimodal or multi-omic approach. We most recently have indicated that we are going to start expanding into digital diagnostics to complement our proteomic and genomic solutions. As I referenced earlier, we have five Medicare-covered tests. Three of those have advanced diagnostic laboratory status.
We have over 20 New York State CLEP approvals for both genomic and proteomic solutions, and we have four tests in our pipeline. I will discuss each of these in a little bit greater detail. In our most recent earnings call, we were proud to share that we have maintained our industry-leading gross margins at just under 80%. We had 21% year-over-year growth, and we continue to reiterate that we will hit Adjusted EBITDA break-even in the fourth quarter of this year.
I should also offer at the bottom there, you will notice we have 297 teammates. A couple of weeks ago, we shared that for the second year in a row, we received a Top Workplace Award. We take great pride in this. Not only are we focused on positively impacting patients, but we are trying to build not only the most unique, but best culture that we can at Biodesix.
We have two facilities or laboratories. The headquarters is in Louisville, Colorado. Here, this is where we run our IQ Lung, our treatment guidance portfolio test, and all of our biopharmaceutical services. Just outside of Kansas City, Kansas in DeSoto, we have a smaller laboratory and footprint where we run our Nodify Lung portfolio of tests.
Let's dive into the lung diagnostic portfolio. Why lung? Many may ask, and many may underappreciate it.
Lung cancer is still the deadliest of all cancers in the United States. As you can see on this slide, nearly as many people will die of lung cancer as the next three cancers combined: prostate, breast, and colorectal. As you look around the room and you count the numbers, one in 18 people will be diagnosed with lung cancer in their lifetime in the United States.
Unfortunately, it's usually a metastatic or late-stage diagnosis, which has a pretty dire outcome and consequence. You can see here, five-year survival for those diagnosed with metastatic lung cancer is 6%. Currently, one in five deaths related to cancer in the United States are associated with lung cancer. As much as we focus on lung cancer through smoking cessation programs, awareness, we still have a long way to go to make a big, big impact in this market. I've referenced our five tests. We really focus as a continuum of care, and we look at it and say, "Hey, we want to make the earliest impact with diagnosis and detection," and then we want to help physicians when it comes to treatment or therapy selection.
These five tests here cover everything from lung nodule risk assessment to, again, treatment guidance, and we'll go into each of these in greater detail now. We'll start with Nodify Lung, the first two tests on the left. These are going to be pre-cancer diagnosis. When you look at the guidelines that a pulmonologist will follow, you're going to have patients that are found incidentally or through a screening program. Unfortunately, in the United States, less than 10% of screen-eligible patients actually participate in a screening program. The majority of these patients are found incidentally. What that means is they've gone in for another reason or rationale, and something is identified as suspicious. They need to follow up on that. When they walk into a pulmonologist's office, the pulmonologist will assess their risk of malignancy utilizing a handful of calculators and also their judgment.
You can see here that the guidelines really clearly delineate that a greater than 65% risk of malignancy, intervene, move quickly, pull those patients in. On the opposite end of the spectrum, for those very low risk, less than 5%, same thing. They know with a high level of confidence this patient is healthy, and they can take a wait-and-watch approach and support that with annual CT surveillance. Sadly and unfortunately, 80% of the patients that present reside in the middle category of low to moderate risk, ranging from 5%-65% risk of malignancy. This, in the guidelines, it actually states that it's open to physician judgment. So prior to launching our two tests, we conducted some research and said, "What's the literature tell us?
How are the physicians doing in their judgment? What we found was that historically, 62% of patients that received a biopsy had a biopsy conducted on a benign nodule. At the opposite extreme up to the right here, 17% of patients sent to CT surveillance actually had a malignancy. You can see both over and under treatment of patients. The stats that we found and identified was nearly one in three patients that had a surgical intervention had a surgical intervention or a wedge resection done on a benign nodule. It really fits into those unnecessary, expensive procedures that healthcare administrators are starting to focus on.
I'm going to go back real quick. I want to highlight here that the guidelines have not been updated in over 10 years. I think it's critically important to appreciate that the ACCP, or the American College of Chest Physicians, recently announced that they are updating guidelines. They're fully expecting an update in 2025. The annual meeting, which is called CHEST, usually occurs in October or November. At the latest, we're anticipating that we could see guideline updates roll out in and around that. We'll talk a little bit more about what we've done to ensure we've put ourselves in a good position for guideline inclusion.
You can see this similar workflow, and now you see where our two products fit in. These two tests are simple blood draw. Again, they're run out of our DeSoto, Kansas laboratory, and they're run in sequence. Notify CDT is your rule-in test here where identifying those patients with a likely malignant nodule.
The complementary test, Nodify XL2, will only be run on those patients that do not have a positive CDT. About 15% of the time we're seeing a positive CDT, or looking at it differently, about 85% of the time both tests are being run. Again, we reference these two tests. They are two unique tests. You can see here, Nodify CDT. Here we're measuring seven autoantibodies on an ELISA platform. This test has a 78% positive predictive value with a 98% specificity because it's a rule-in test. That's what matters most.
We return this test result back within 24 hours of receipt in our laboratory. Again, because we're identifying those patients with a likely malignant nodule, time matters. Early detection and diagnosis is key and critical. Returning those results in 24 hours allows those physicians to then pull those patients forward to intervene and address that situation appropriately. As I've stated, all of our tests have Medicare coverage with private payer coverage, continuing to grow and increase on a monthly basis. The complementary test, Nodify XL2, here, this is your rule-out test. It is a multi-omic test where we're using a number of clinical factors in combination with two proteins that are measured on an LCMS platform. This test has a 98% negative predictive value with a 97% sensitivity. This test will return those results within four to five business days. Again, because you're ruling out cancer, time still matters, but within a week, we can return both test results confidently, allowing physicians to know who do they intervene on and then who do they take a wait-and-watch approach.
We currently have two studies, one Altitude and the other Clarify. I'll talk a little bit about those. As a data development company and the first mover status that we have as a company, it's a responsibility on us to continue to demonstrate not only efficacy, but utility in this marketplace. We're proud to share that we have a very robust clinical data package. Here we've listed out 15 of the more important and significant publications, ranging from discovery to analytical validation, clinical validation, clinical utility. More recently, you can see we've started publishing a fair bit on health econ and outcomes data. I referenced Altitude and Clarify here. You can see that they'll fit into the clinical utility category. Altitude is a first of its kind for this physician group. It's a randomized prospective study following the American Thoracic Society guidelines for study design.
This study is being managed by a data safety management board, so the team and company are blinded to test results. We're eager to continue to provide updates, and as we learn more from upcoming data safety management board reviews, we'll share that publicly. As a first of its kind randomized prospective study, we fully anticipate and expect similar and consistent results that we've seen in the past. Obviously, this puts us in a wonderful position for guideline inclusion. Clarify is the more recent study that we kicked off late last year. This is a retrospective chart review study. What's unique about this is we have the ability now with our commercial successes to go back and actually do chart reviews and look at patient outcomes at one-year and two-year time points. We now have over 870 patients enrolled in a very short period of time.
This is also going to allow us to look at some real-world considerations. One that we've shared and disclosed publicly is how does our test compare to the results from PET scans? In this patient population, what we know in working and collaborating with pulmonologists is every one of these patients receives a PET scan. Unfortunately, almost every one of them pops or lights up, and so they aren't as useful as they should be. When you talk about an exceptionally expensive procedure, we think that we can demonstrate here that I'm not going to state that we'll forego the need for a PET scan, but we can be complementary and add additional information to the clinical decision-making.
More to come here. We are working towards an interim analysis or two for CHEST out of the Clarify study, and we'll look forward to providing updates as we progress towards that meeting. This is a new slide and something that we use commercially. We call this our clinical utility review tool. We have tracked every patient, and what you see here is a pretest risk of malignancy that the physician assigns and then a post-test change. The data is the same between both of these images. On the left, you have a scatter plot, each one of those representing a patient, and the colors showing redistribution. What you see here on the left is a line at 65% and a line at 5%. Remember, between the 5% and 65% risk of malignancy is where test utility is most applicable.
You can see how we've redistributed going all the way up to a 95% risk of malignancy post-test result. On the right, this is a Violin plot. It's the same data, just showing it differently. You can see going back to that data that we had where physicians make utilizing their judgment, and they make a decision, and they state that risk of malignancy is between 5% and 65%. Our post-test results start to show how you're redistributing that post-test risk of malignancy. What our sales team will utilize this tool for is going back in and doing clinical consults at each and every user, highlighting how decision-making has changed. We are continually educating on the value of our test and how they can continue to implement it more broadly within their practice.
You can see over 100,000 patients are now included in this database, and it is HIPAA compliant, but we'll continue to build this data out. The nice part is, is what we've shown is that it's generalizable. Our initial clinical studies, we've maintained the same performance in a real-world population. That is what gives us confidence that the Altitude study and Clarify will continue to build upon this exceptionally strong data. We recently discussed an expansion and an evolution of our sales team. What we have is now we plan to have 50 different territories, or we're calling them pods internally, anchored by a pulmonology sales consultant. We disclosed that we did a pilot in the second half of last year assessing the feasibility of calling on primary care physicians.
The rationale here was we knew that nearly 50% of this patient population never makes it to a pulmonologist. They're stuck in primary care. There are a number of reasons why they may be stuck. With working through the referral patterns, we knew that we could help unlock this. The question for us was just, when did we make that change? When did we start to address this? Middle of last year, we had a number of pulmonologists that began doing it on their own. What I mean by that is they said, "Hey, we value the test results, but we want to push that out into our referral network so that those referral physicians know who to refer on, ultimately enriching my patient population as a pulmonologist." This is a better representation of highlighting what was and what we plan to do here.
The scary thing about primary care is there's approximately 250,000 primary care physicians in the United States. We are clearly not planning on calling on 250,000 physicians. I can state that again, we are not calling on 250,000 physicians. By looking at claims data, what we've seen is 80% of those patients that are referred on and identified are done so out of about 14,000 primary care physicians. It is much more manageable and addressable, and it is similar in size to the number of pulmonologists that we have in the United States. The goal here is to work with ordering pulmonologists, educating back into their referral pattern, providing support and utilization of our test. The ideal way that this will work is a primary care physician now can see a more enriched population where a Nodify CDT positive patient is referred on.
Those patients that have a positive Nodify XL2, meaning that it is a benign nodule, can stay in primary care where an annual CT scan will provide additional guidance if there is change or need to refer the patient on. We will continue to keep you updated here, but we are excited. Some of those early accounts that started to do this, what they have shared with us is they have actually now seen a state shift. By doing so, they are getting to patients earlier. They are diagnosing more early-stage lung cancer. We plan on publishing this data, and as they do, we will make that readily available to others. That is the ultimate goal. Early detection and diagnosis enables us to have a positive impact in this patient population. Now let us shift to post-cancer diagnosis, where we have our IQ Lung portfolio of products providing treatment guidance to physicians.
We've stated how dire a lung cancer diagnosis can be. You can see that those patients diagnosed with advanced-stage non-small cell lung cancer have a median overall survival of 10.5 months, not even making it to the one-year anniversary of their diagnosis. Historical use of tissue testing can take close to one month to get those test results. You are either waiting one month to prescribe treatment, or you are foregoing those test results and providing a treatment plan in advance of receiving those results. With blood-based treatment options, we focus on turning those test results around within three to four days and informing physicians what's the ideal treatment to place a patient on.
For early-stage lung cancer patients, we offer a targeted DDPCR panel where we're focused on four genomic mutations associated with lung cancer in complement with our VeriStrat test, and I'll talk about it here in a moment. Then for those advanced metastatic or recurrent patients, we offer a 52-gene NGS panel to provide a broader view on what's going on genomically. We think it's critically important as a multi-omic, multimodal company to see both the proteomic and the genomic side. Not only do we value what's going on genomically in looking at how the cancer is acting and behaving, but we think it is equally as important to understand what's going on with the patient's immune system. I'll start on the right here. VeriStrat is a proprietary test that we developed and launched. It is a proteomic test.
Here we're identifying a chronic inflammatory disease state. When we studied this in 5,000 patients in our INSITE trial, what we've been able to highlight is we're able to provide guidance to physicians as to when a patient's immune system may become compromised. What that ultimately would mean to them is it's a failed treatment, and it's time to change a treatment approach. This test can be ordered serially at multiple time points and provides wonderful insights as to when that treatment, again, is failing and/or when the patient's immune system has been subverted by the cancer. We talked a little bit about the VeriStrat DDPCR test. You can see a 91% sensitivity, 100% specificity, and then the four tumor mutations that we're focused on, which are relevant for non-small cell lung cancer. Again, a 52-gene NGS panel, 95% sensitivity, 100% specificity.
Both these test results are returned within two to three days in comparison to the average 26 days for tissue testing. Transitioning to our product pipeline, we stated that we have four tests currently in development. Recently, we disclosed that we plan on merging our risk of recurrence and MRD efforts. By end of year, we plan on having a solution that can start being tested and utilized in the biopharmaceutical community in a research use-only capacity. What makes this unique is we're going to blend both the proteomic and genomics, just like we have in our IQ Lung test prior. The risk of recurrence test is something we discovered where we can identify those patients with the highest likelihood of recurrence before they have surgical resection.
When you really think of that, going into a surgical resection, you know which patient has the highest likelihood of recurring, so you can take a more aggressive approach in treating them. We will support that and follow that with longitudinal testing on the MRD side. We are planning an R&D day here in the fall. At that point in time, we will disclose much more in what we are doing here. Some recent presentations have been made at liquid biopsy meetings, two different meetings earlier this year with us and Memorial Sloan Kettering and the Bio-Rad team. More to follow there.
We talked about VeriStrat. We are working on expanded indications for VeriStrat in different disease states. The first here, you can see VeriStrat really focused on immunotherapies. What we have demonstrated is that VeriStrat has the ability to identify those patients that will respond favorably to an immunotherapy and those patients that will not. We will continue to provide information here. This provides us opportunities to start to expand outside of lung. You can see there is value here with other solid tumor types. Anything that we are doing outside of lung, we are open to partnering and collaborating with others because we do not have plans to expand our sales force to anything outside of lung at this time. That is really important when you see the next application for VeriStrat and our partnership with Memorial Sloan Kettering and their biomarker team, which is led by Howard Scher, one of the leading prostate cancer physicians in the world.
What we've done here is taken their biobank and looked at a number of prostate cancer patients, especially those that were castrate-resistant metastatic prostate cancer patients. We've been able to highlight that we can identify those patients that will respond favorably to hormone treatment and those that will not. Very excited about that. Again, here, we plan on working with Memorial Sloan Kettering and a number of companies and researchers on prostate cancer to ensure that this test gets in the right hands so that we can make a big, big impact in that patient population. More recently, we disclosed that we have begun expansion into digital diagnostics. I talked a little bit about this on our most recent earnings call.
We have a number of opportunities to pull more data out of EMRs, out of radiologic exams and material that can better identify patients, can better pull patients forward, but also it gives us the ability to improve test outcomes. Again, at that R&D day, we'll provide greater detail. We did highlight that we have now added a head of radiomics, Dr. Michael Kammer, who was most recently out of Vanderbilt. We're excited to let him run, have him on the team. Him and Gary Pastana are going to make a wonderful partnership as we focus on that full platform of genomic to proteomic to radiomic solutions across lung disease. Again, more to follow here on the Biodesix R&D day in the fall. Developmental services. This meeting is really on the heels of ASCO here in Chicago.
Our biopharmaceutical engagement was really strong this week. This team continues to build a wonderful book of business. We disclosed at the Q1 earnings call that we had $10.9 million of contracted research, but not yet recognized revenue currently on the books. For the most part, or directionally, that'll be recognized over the next one to three years. This team continues to build an exceptionally large book of business. We offer both proteomic and genomic solutions, and we look forward to expanding into the digital side once we have a solution there. When we look back at our broad portfolio of tests, what we find is our biopharmaceutical partners really look towards utilizing DDPCR and NGS in a number of research applications. We also will be adding those product development pipeline tests to this.
We will start increasing the research on those tests here in the coming months. Let's talk a little bit about our Q1 performance, being mindful of time. We disclosed $18 million in revenue in the first quarter, growth of 21%. We continue to see strong growth across the portfolio. The two sides of the business represented here, you can see $16.3 million in revenue for our lung diagnostic testing, which grew 18%. As I mentioned, the exceptionally strong growth on the development services side with 61% growth. Gross margins, we've stated they're industry leading. We've also disclosed we fully expect them to stay in the high 70% and hopefully can get to the 80% range. We have reiterated that we plan on getting to Adjusted EBITDA break-even by year-end.
You can see the significant improvement that we continue to make and fully expect similar improvement as we progress through this year. We most recently not only reiterated that we would get to adjusted EBITDA break-even, but we revised our guidance to $80-$85 million for the fiscal year. Robin and I are really excited to be here. We're happy to meet with everybody today during one-on-ones. We think that 2025 is a transformative year. As I state to the Biodesix team, there's never been a better time to be a part of this team. Not only do we have that responsibility to build a market, but we continue to do so by developing data. What you're going to see is those data development decisions that we're providing physicians an opportunity to make will change a marketplace.
As we continue to publish with both altitude and clarity, we have created a pretty significant moat around the business, not only from an IP protection perspective, but the number of years that we have of not only researching and learning. We are going to continue to apply those learnings and expand that product development pipeline. We are mindful that one of the single greatest assets we have is the largest pulmonology-focused sales force focusing on lung health. We will continue to not only invest in them, but leverage that team. With that, thank you all for your time today. I really appreciate it, and we will look forward to meeting with you later.