Bobby Hill, Senior Vice President and CCO, and then finally Luke Power, CFO from Caris. They recently IPO'd less than a year ago, and will have a presentation. If you have any questions, towards the last two minutes, please raise your hand. We'll be happy to take them. Thank you for being here.
Great. Well, thank you. This is our first conference here, actually, after many, being public with our IPO last June, so i t's a pleasure to be here. I think my main point that I'd like to just start out with is, you know, although we've been at this since 2008 with our company, we're looking at opportunities in the marketplace that we think are more remarkable facing our platform than we've ever seen. We've been building this business since 2008. We got a very early look at multi-omics with the Molecular Profiling Institute.
We launched, as you know, whole exome, whole transcriptome, 23,000 genes, well in advance of anybody in the marketplace, and t hat has really helped define us and has put us in a position here to benefit, we think, from all of these amazing trends in precision medicine, precision oncology, and in particular, cancer genomics. We've been building this platform for many years. We think it's defined in large part by our technology. The 23,000 genes is not a reflex or part of the menu, but every single patient has gotten this for many, many years, so w e're scaled up now. We're annualizing at over 200,000 profiles on an annual basis, so w e have scale, we have broad reach. We're reaching now over 6,100 oncologists in the U.S.
Every time we profile a patient, the amazing thing about our business model, that goes into our data set, which is one of the largest I think Milan is the largest transcriptome set actually in the world, so o ver one million genomic profiles, most of which now are matched with clinical outcomes, and t hat powers us, it powers our R&D internally, and it makes us extremely attractive to our partners, both academic medical center partners which are also clinical partners for us, but also in the biopharma community as well. The data set continues to grow. It's a very important part of our business, as I mentioned, in many respects, and grows every time we profile patients.
The trends here, we get a lot of questions. I think we've seen as many opportunities today, if not more, than in the eight years that I've been at this company. So the TAM is large, is growing. There are a number of names in the space, but nevertheless, the penetration rate against the therapy selection, TAM alone is only about 35% penetrated, and the penetration rates, of course, in some of the new exciting modalities like MRD are extremely small. That business is really just beginning. Molecular profiling has emerged as the standard of care, so that's the good news, but t here's a lot more work to be done in getting every patient profiled from a cancer center leadership perspective, getting them profiled consistently and systematically.
It's hard to run these organizations, so getting all of the different oncologists to behave in the same manner and apply a precision oncology program in a thoughtful way is part of their challenge. So platforms like ours, and I think in particular our platform, is very well suited to help them provide the best technology, but also assist their physicians, their various departments, and these are complicated organizations, to get patients profiled properly, early, and with the best technology.
We have a whole organization, a whole channel that Bobby runs that is set up to do this, with senior people who cover the cancer center leadership, as well as the salespeople who cover the individual oncologists, a team of 50 Ph.D.s in molecular medicine, MSLs, who help with the interpretation and support the oncologists in finding the right clinical protocols, trial eligibility, et cetera.
This revolution in molecular medicine is really just beginning, and a ll of the hard work that we and others have done over the past number of years is really, I think, setting us up over the next five to 10 years for just a remarkable time, a remarkable time of introducing new modalities and creating an environment where molecular information is delivered in a strategic way across the cancer centers at the individual oncology level as well as at the institutional level. The cancer centers are moving towards institutional decisions as a result of this, not just allowing the individual oncologist to do whatever he or she happens to want to do, including not profiling in some cases. There's still some amazing situations that you hear about where patients aren't getting profiled at all.
So all of this is really an opportunity for us to deliver the capabilities in a partnership sort of way. So these trends, I think have are ones that we've thought about for many years, and we've set up our channel, our commercial channel and our research channel to take advantage of these trends, but also serve our client base in as effective way as we possibly can.
Starting with our philosophy, which is patient first, I'd say interestingly, our move to whole exome, whole transcriptome wasn't a result of a decision around a particular economic or market opportunity, but really was oriented around what's the best thing for the patient and how can we help the treating oncologist, give them the best tools to help the patient. So everything we do is oriented around a patient-first philosophy. We have been investing in our platform. We think our platform is highly differentiated, very effective, et cetera. We went through a period of time, frankly, where we were capital-constrained prior to the IPO, so c oming out of that, we are engaging in a very deliberate investment program that's being led by Bobby, who's been in the seat now, the CCO, the Chief Commercial Officer seat for two quarters.
He's bringing new leadership, new energy, new tactics, many things that I think are gonna be fabulous, actually, for us and for the cancer centers, and w e're also complementing that with an investment program to increase the headcount, the FTEs, increasing the number of territories, as well as building some new and strengthening some other specialized product-oriented sales forces, so w e think there's a tremendous amount of upside, and Luke will talk about this in terms of our case volume growth, beyond what we've put up for the last couple quarters, and we're very excited about that. We cover not only the individual docs, as I mentioned, but also the senior leadership at these cancer centers. We think we do this in a unique way, in part through the Precision Oncology Alliance, which is dynamic.
It's growing. It's now at 100 sites. So we added UC San Francisco, an NCI site, obviously in San Francisco, a very important one that got us to 100, so t his is a very important collaboration around research and data. It's something that they love. They view it as their own, and they have the opportunity at its core to get access to our data set for their own research with us, et cetera. It's extremely dynamic. This is a force, actually, with 100 members now. When I joined the company eight years ago, we had 19 sites, right? There were a couple of other collaborations like this that were similar size, and those no longer exist.
Ours has sort of emerged as the leading collaboration in precision oncology, and I would also argue maybe even more broadly in precision medicine, and we're seeing opportunities to extend into the other disease states as well. That represents, of the 10,000 medical oncologists in the U.S., it represents about 4,000 of those oncologists, so i t's a pretty substantial part of the overall market in its own right. Maybe just summarizing, I'll turn it over to Milan. We go to market in a way we think we're highly differentiated from a technology perspective. That's true for our existing therapy selection products. We just launched this last month, a very exciting whole genome platform in hematological cancers called ChromoSeq.
We also launched a dig path technology called MI Clarity for a chemo predictor in breast cancer, so w e're very excited about those in terms of completing the continuum of care, but also in continuing to enhance our relevance and importance at our cancer center partners. The financial profile, which Luke Power will talk about, is, you know, we put up 79% growth last quarter, year-over-year in revenues, 85% in molecular profiling, and t hink that the fact that we're profitable and have been for the past four quarters profitable, free cash flowing, our balance sheet cash on hand is growing. This gives us huge strategic flexibility to do a number of things from our product pipeline, which is so exciting in the MCED and MRD area. With that, Milan.
All right. Thank you, Brian, for the great introduction. Pleasure to meet you guys. Milan Radovich, Chief Scientific Officer. What I'm gonna do today is walk you through our technology platform and then talk a little bit about biopharma. As Brian already alluded to, Caris has really prided itself on always being as comprehensive as possible. We standardized on whole exome and transcriptome sequencing in 2019. We have the only FDA-approved whole exome and transcriptome on the market, and w e do this type of comprehensive sequencing looking at every single gene in the genome, both at our tissue, but also in blood. We do this for two reasons. One, we want to leave no stone unturned to identify a drug or a clinical trial for a patient.
Prior to coming to Caris, I was in the clinic for many years, and I used to explain Caris testing to patients as you're about to get the Star Trek of technology, and if there's a drug or a clinical trial out there, we're gonna find it, and w e want to be able to give our patients every shot on goal as possible to figure out a vulnerability in their cancer that we can treat. But secondly, and as I'll touch on later, while our number one goal is always the patient of today, we also know that this data can be used to help the patient of tomorrow, and we use our data vastly for research with the Precision Oncology Alliance, as Brian mentioned, with pharma, and also for internal development. With Caris Assure, we are really excited by this platform.
It's really a revolutionary product on the market to look at the entire exome and transcriptome in the blood and be able to apply that across the care continuum. Currently launched for therapy selection, but we have significant efforts in developing this for monitoring. We have efforts in MRD, and a s I'll touch on in later slides, with Caris Detect, a whole genome platform for early detection. So when it comes to our comprehensive molecular profiling, I won't dive through all the details here, but I think really, again, the high-level point is that when you go comprehensive, when you go broad, you can capture the litany of every potential analyte you can think of from a sequencing platform.
Things that are basic like mutations and copy number fusions, but things that are much more complex, things like AI signatures and others that allow us to, again, give patients every shot possible, giving them a complete answer for the treatment of their cancer. One thing about this comprehensiveness is that it gives us a lot of versatility, as you can imagine, with its application for clinical care. One of the things that I love about the versatility is that when a new biomarker, a new clinical trial comes out, we don't have to redevelop our panel. We don't have to add a different gene, go through CAP/CLIA validation, so on and so forth. We already capture it.
What's really cool at Caris is that we have an evidence team who all they do every day is actually monitor literature and abstracts and so on for the latest in evidence in NCCN guidelines, and t hen a new drug is approved, our team will actually go back, usually a year, identify every patient who is positive for that biomarker, and we contact the physician to let them know. Say, "Hey, your patient is positive now. This drug is recommended." We don't do that at any charge. That's just part of our standard of care of what we do at Caris. Also, by having this comprehensive sequencing, we're able to use really cool AI signatures that we develop.
I'll dive deeper into GPSai in later slides, but this is really important because when you are analyzing 23,000 genes across many, many, many hundreds of thousands of patients with a variety of different clinical outcomes, frankly, the human mind cannot actually hypothesize or determine what is the patterns that could help determine, let's say, a responder from a non-responder or be able to predict prognosis. You really need powerful AI tools, and AI, while it's such a buzz term today, it's been in our DNA for many, many years. One thing I always like to say is that, you know, Caris was doing AI before ChatGPT wrote your kids' essays. I mean, we've been doing it for a long, long time.
For many years, we have, I forget now, almost 80+ Ph.D.-level data scientists at Caris who are mathematicians, computer scientists, who are really mining our data on a daily basis to really come out with the best endpoints. One of the things that was really cool, I'm biased as the first author, but this paper published yesterday, where we actually showed that TMB, so TMB stands for tumor mutation burden. If you guys are not familiar with what TMB is, TMB is how heavily mutated a cancer is. When a cancer is more heavily mutated, it looks more foreign to the immune system, and when it's more foreign to the immune system, the immune checkpoint inhibitors work better.
When you block a target called PD-L1, these cancers tend to be more uncovered to the immune system, and they tend to attack it better. Well, TMB is calculated by counting all the mutations, and w hat a lot of people have tried to do is they'll use small gene panels like 300 genes or 600 genes or whatnot and estimate what the total mutation burden is from just a small sliver of the total gene pool. We at Caris measure all of it, so b y definition, our estimate is more accurate, and the academic literature suggests that as well. What we showed yesterday was for the first time, not only is it more accurate, but it actually does a better job at predicting outcomes to immunotherapies.
The first paper ever to demonstrate that TMB by whole exome results in improved outcomes, not just better assessment, but improved outcomes, so w e're really excited. This paper just published yesterday, and we're excited to be talking more about it today. As I mentioned, with our whole exome and transcriptome, it is the only FDA-approved whole exome assay and transcriptome assay on the market, FDA-approved with 8 CDx indications across 20 therapies. What does this mean? Does this mean that Caris does a better job taking care of patients after FDA approval than before it did? No. What it does is it gives a stamp of approval that the quality of our test, and its reproducibility, and its sensitivity and specificity meets the bar of the FDA, and that when people are getting a Caris test, they have reliable results.
Kudos to Dr. Oberley, who's our Chief Clinical Officer. He helped lead a lot of initiatives. It was a 15,000-page submission, took massive amount of effort, but really a testament to the work that we do at Caris. Building on our legacy in tissue, we launched now a couple years ago, Caris Assure, which is also whole exome and transcriptome, but this time on blood, and a s many of you know, liquid biopsy has really revolutionized our capabilities to do molecular profiling in a very non-invasive method. As I used to tell patients, there's not a line of people outside the radiology suite to get a tissue biopsy. It's not really fun. I'm telling you right now, it's not fun, but a liquid biopsy is easy. It's a blood draw they can do in clinic.
What we've learned is that we can really amass a huge amount of information with using these really sensitive next-generation sequencing techniques, and w hat's really cool is that the way that we can see these technologies applied is that these platforms are really complementary. They don't replace each other. They're complementary, so e very patient's gonna get a tissue. You can't have a cancer diagnosis without tissue. Tissue remains the gold standard. It's the most sensitive, and i t allows us to do not only sequencing, but other types of tests like immunohistochemistry for guiding therapy, but w hat we know is that cancer evolves, and getting a blood-based biopsy gives us additional information on the molecular makeup of the cancer, so t hese are really powerful when used together, and Luke can talk more.
We're seeing a lot of docs use these tests in a combined fashion and also to monitor patients while on therapy. One of the important things about what we do at Caris, this is gonna be a surprise to some of you, but we sequence the plasma to look at tumor-derived DNA and RNA, but we also sequence the white blood cell layer or the buffy coat to look for germline mutations, meaning mutations you were born with that may predispose you to cancer, but also to determine definitively these mutations called clonal hematopoiesis or sometimes called CHIP. You can amaze your neighbors when you learn if you learn something new today. CHIP are mutations that are naturally occurring that tend to increase with age, smoking, and prior chemotherapy exposure.
A guy like me has more CHIP than a young guy like Kyle right here. What these are is these mutations; they're naturally occurring, and what happens is sometimes they actually occur in cancer genes that make it look like that mutation came from the cancer, but it actually didn't. It came from our white blood cells, and w hat that does is it causes interference in our interpretation of these liquid biopsies. Caris is the only test on the market that actually definitively determines these mutations and effectively subtracts them so that our oncologists are not making incorrect decisions based on mutations that don't actually come from the cancer, that actually come from these naturally occurring mutations. I'll end off here on the pipeline with GPSai. Actually, this is also an algorithm led by Dr. Oberley, who's here in the audience.
This was an AI algorithm that we run on our tissue test that determines the tissue of origin. It was originally designed to help with cancers of unknown primary. This is when a patient is diagnosed with cancer, and they don't know where it comes from. I will tell you, it's actually one of the most scariest situations for a patient. Your doctor comes in the room, says, "You have a terrible cancer, and by the way, we don't know what it is, and we don't know how to treat it." It's extremely scary. Having GPSai has been phenomenal. It's highly accurate for 90 tumor types, highly sensitive.
What we also found it to be really helpful is not just in diagnosing cancers of unknown primary, but every day we get about one to five cases where the AI algorithm actually says it's a different diagnosis than what comes in on the pathology report, meaning we're finding misdiagnosed cases, and t hat's also equally important because the fundamental basis of all cancer therapy is based on what type of cancer it is. Matt and his team do a wonderful job of calling physicians, doing the additional workup, and every day are overturning diagnoses so that patients are always getting the right diagnosis. This is just part of our standard of care at Caris. Moving on with the pipeline, as many of you know, we've been really excited by our early detection results.
You just need to read Alex Dickinson's post on LinkedIn. He's very excited, but a s you know, we are really pioneering our work in early detection, applying a whole genome approach to be able to take as many shots on goal to be able to detect a cancer signal. Our early results with Achieve 1, which is a roughly 3,000 patient case control cohort demonstrating fantastic 60.3% stage one two sensitivity while maintaining really high specificity, and t his is really important because if you're gonna have an early detection test, you know, your test has to catch it early, and I think for us, that's the bar, and we're really applying again, the most cutting-edge genomics approaches, but also AI approaches to be able to detect cancers at early stages.
As you may be aware, there's others in this, in this space who have been having real difficulty with things like breast and prostate cancer early stages. As you can see from the data below, our results are showing to be considerably better than what you're currently seeing out on the market. We also launched recently Caris ChromoSeq™ . This is our first whole genome assay for therapy selection for hematological tumors. It's launched for AML, MDS, and MPN. Originally developed at Washington University, but we licensed it and then further improved upon it, and really allowing us to fill a gap in our sequencing to be able to be comprehensive as possible at cancer centers being able to service both their solid tumors and their heme malignancies.
I also like to point out, obviously, thankfully, relatively uncommon, but as you guys know, with pediatric cancers tend to have more hematological malignancies, being able to service our pediatric populations much better now that we have this whole genome test. We're developing a variety of tests to cover our entire pipeline, as I referenced previously, Caris ChromoSeq™ . MI Clarity, as Brian mentioned, is actually a digital path AI algorithm determining breast cancer recurrence. Think of it as a dig path alternative to Oncotype and to MammaPrint. As many of you know, this is a very large population, and it's actually a large population that doesn't get sequenced because chemoendocrine therapy is standard of care, and this really enables us to have access to a large population with this cutting-edge molecular profiling, and then w e're also building out MRD solutions, both tumor-naive and tumor-informed.
I'll end here with Biopharma, which I also oversee, and i n Biopharma, we have three major pillars. We have our core Biopharma services, which is our molecular profiling of clinical trials and banked tissues and joint research we do with pharma. We have our strategic data. We have amassed the largest data set in cancer, whole exome and transcriptome, and this is obviously valuable to pharma for their development and have a lot of active deals and a lot of partnerships in the pipeline, and then w e have Caris Discovery, which is our division of Caris that's dedicated to using our data, our tissue, and some proprietary proteomics technologies for the identification of novel drug targets.
Just an example, very recently, our largest deal, our pharma deal in our company's history with Genentech in December, which is for Caris Discovery, which is a partnership to identify novel drug targets in refractory tumors with a significant upfront and milestone. I will tell you, the Genentech scientists have been an absolute joy to work with. It's a scientific nerd fest between us, to be honest with you. I'm actually gonna be there on Friday again for yet another one, so w e have a great relationship, and we hope to really change the face of cancer with this relationship. With that, I'm gonna hand it off to someone smarter, Mr. Power.
Definitely not smarter. I'm the reason why I go last. From a performance update, obviously, we publicly disclosed our Q1 results last week, and it was another very strong quarter for us. From an operating standpoint, we have great operating leverage right now. Our revenue for the quarter obviously grew 79%, with molecular profiling leading the way, with blood and tissue both above 80%, and a gain, that's driven by two key factors. Obviously, for us in the molecular profiling space, there's going to be a P* V, so the price and the volume. Our volume growth grew 15% year-over-year as we're working through kind of ramping up that sales force, but our ASP also grew 61%, and It's that leverage, the combination of those two things in the equation, is driving that great growth that we've seen since we've been a public company.i
Obviously, that's translating to the bottom line too. We're very unique in that we've been now, for the last four quarters, free cash flow positive, and w hat we're doing with that free cash flow is obviously we're reinvesting in the business. Milan went through the pipeline, and that's something that we're gonna push hard on this year, with detection being kind of the primary focus over the next couple of months, along with MRD and obviously scaling up MI Clarity and ChromoSeq, and then continuing to work on our MRD platform. From an additional operating highlights standpoint, obviously, we reported at the Achieve 1 study that Milan went through.
As Brian touched on, because of our unique financial position, we're also able to refinance our debt and get lower interest rate, which again, is positive from an EPS standpoint, but i t also allows us to have additional strategic capital in order to exercise on our kind of initiatives for this year. So from a Caris standpoint, we've always been clinically focused. That's why the majority of our revenue has been driven by the molecular profiling unit. Now, what we're doing this year is we're expanding both units. Our molecular profiling sales team, led by Bobby, is going to be increasing by 25%-30%. It's the same with our pharma team.
Again, it's because of the operating leverage that we have, because of the decisions we made years ago to go to whole exome and whole transcriptome and get and seek a higher reimbursement for that, because it is the broadest test out there. It allows us, from this financial position of strength, to execute throughout the year and continue to drive the top line. Excuse me. Again, moving to kind of the clinical volume, so part of the equation, the V of the equation. Obviously, the 15% was still very profitable growth for us. I think what we wanted to execute on this quarter, we did from a realignment of the sales force that was disruptive in January, but we felt very good coming out of that, and how we set up for the rest of the year.
The other key thing from a Q1 standpoint, obviously, we've been primarily focused on tissue for many, many years. Like, we're one of the leaders in the space from a tissue standpoint, but we're also continuing to gain penetration within the blood market, so o ur Caris Assure volume grew 58% in the quarter. Again, it's the smaller end that it's starting from, but it's continuing to show the penetration that we're getting from having a unique assay in the field, obviously doing whole exome, whole transcriptome, and CHIP. We have 270 folks at the end of Q1 on the way to 300, and we'll continue to assess that as we expand throughout the year because again, the financial profile of the company allows us to do that, and the growth that we get from additional salespeople is obviously a very high ROI right now.
From a financial overview standpoint, obviously a lot of people in the space have about, like, mid-60s gross margin. It gets a little lost sometimes. We manage to achieve that by doing the broadest panel possible, doing whole exome and whole transcriptome, so w e don't have to go and continue to add to our assay. So many people, obviously, you start with lower genes, you'll continue to see that expand. We decided years ago, based on David Halbert's vision, is to go as broad as possible so we can future-proof our assay. Now, what that allows us to do from a financial performance standpoint, it allows us then to continue to get efficient with that.
As sequencing improves, as the cost of sequencing comes down, you will see, based on us pursuing reimbursement, our COGS are gonna continue to come down based on the advances you're gonna see over the next coming years. Again, that all flows down to the bottom line, which is the whole purpose of this strategy, is this continual flywheel of more and more data coming in, sequencing costs coming down. It will allow us to continue to generate, like, a solid bottom line going forward, and w e're not just chasing profitability. We've already achieved it. So molecular profiling services performance, one of the key things for us for the last four quarters is obviously we've over-excelled from an ASP standpoint, so o ur molecular profiling for tissue was just under $4,100 for Q1, and then o ur Caris Assure assay was just under $2,421 for Q1.
From a reimbursement standpoint, one of the key things that gets lost is these are not ADLT tests, they're CDLT tests, which is different, so t he pricing structure and what we actually do is more stable over a longer period of time based on PAMA reporting. From a tailwinds standpoint, I'll start to wrap it up. We've done great over the last year with our payer contracting. Obviously, you can see it in the numbers, but especially with MI Cancer Seek, it's over 225 million covered lives, and that's within the space of one year. We're continuing to take that approach into Assure now, and that's kinda the next focus for our market access and our billing teams as we progress forward.
Ten, from a full-year guidance standpoint, we reaffirmed our guide. We feel really good about that right now, based on how we saw things coming out of Q1, and I think a s we progress throughout the year, obviously you're gonna see MI Clarity, you're gonna see ChromoSeq revenue, you're gonna start to see Caris Detect launched, and that will continue to kinda compound on top of this initial guide, which does not include any of that. Two seconds.
Questions? Derek, come on. We miss you. Give us a good question.
No questions. Thank you so much.
Yep. Thank you all. Thank you.