Okay, we're going to kick it off. I'm Tucker Peterson from the Life Science Team. It's my pleasure to introduce our next company, GeneDx. With us, we have Katherine and Kevin. Welcome to you both. You've had a great year. You've beaten rays each quarter, a number of new indications, multiple newborn screening partnerships, breakthrough device approval, got the guideline update. Maybe just talk a little bit about some of the momentum you have exiting the year and heading into 2026.
Certainly. Just to orient everyone, GeneDx, we diagnose more children with rare diseases than anyone in the world. Part of the reason why we are so expert at doing that is the sheer size of data that we have been able to amass that is what we call infinity. We have the largest genotypic data asset. It will be comprised of about 1 million genomes and exomes by the end of this year. We have tested more than 2.5 million people with rare diseases. 60% of the time, we're also testing mom and dad. We have an incredibly enriched and vast data asset that we've been able to build. We've also amassed more than 7 million phenotypic data points that serve as a complement to the genotypic information.
Combined, we're able to provide more accurate answers at scale than anyone in the world for people with rare diseases. One in 10 Americans has a rare disease, and it takes on average five years for a child with a rare disease to get an accurate diagnosis. We can do that today in 48 hours in the NICU and in two to three weeks in the outpatient setting. We have a massive opportunity to be able to eradicate that unnecessary five-year diagnostic odyssey through broader adoption and earlier diagnosis of these patients. We've been focused predominantly on selling our exome to clinicians, driving utilization both in the geneticist's office, but more importantly, getting to specialists who serve as an earlier point of connection with these families. Ultimately, we want to get to general pediatricians and into the NICU and, of course, using newborn screening.
We have been focused in that outpatient setting as well as establishing a foundation in the NICU. Most of our growth and momentum really has been driven amongst pediatric neurologists. In that specialty setting where you are seeing a lot of referrals coming out of the general pediatrician, we found a lot of good momentum there, both in bringing new customers onto our platform as well as even deeper penetration into those clinicians. As we look at Q4 and into 2026, we want to continue to drive utilization amongst those specialists as we set up a future paradigm with general pediatricians as well.
Speaking of general pediatricians, big guideline update, right? That was long overdue. Maybe obviously now they can order a whole exome, whole genome for tier one tests to children with GDD, IDD. You sized this at a $2.5 billion TAM, doubling the opportunity. Maybe just talk a little bit about how your thinking has evolved since the guideline update in June.
Certainly. The American Academy of Pediatrics in June updated those guidelines. It was the first time that they've updated guidelines in over a decade. This presents us with a really important opportunity to end that diagnostic odyssey much earlier. As we all know, the first line of defense for any family to go to is the general pediatrician. That is a huge area of focus for us as we think about the market opportunity ahead. There are 60,000 general pediatricians in the United States, 25,000 of them today diagnose children with global developmental delay and developmental disability. We now have the license and the endorsement of the American Academy of Pediatrics, which is now a really important foundation for education amongst these clinicians. Pediatricians, as we all know, are tasked with any number of issues when a family is coming in.
They're tackling so many different topics. We arrived at our first American Academy of Pediatrics meeting at the end of September. We exhibited there. We started the educational process there. What we're learning to note, surprised to us, is that we are oftentimes the first people to be telling general pediatricians about this guidelines update. We knew that it was going to be a large educational effort. We're continuing to invest in medical education and in marketing to raise awareness of the guidelines of GeneDx and really starting to demystify for them what genomics can do in terms of being able to help them help more patients. We are starting the education on not only the guidelines, but the fact that these tests are fast, they're affordable. 80% of covered lives have access to these tests.
They really are tools that are within reach of every general pediatrician. We've said it's going to take about 18 - 24 months to really start to see volumes ramp. That's based on our own experience. Once guidelines come online, I would love to think that every clinician is paying attention to these and that human behavior changes overnight. It takes more than guidelines being published. The educational effort is underway. We've begun hiring our sales team. We are investing in our commercial might there. By the way, we have a larger team today selling exome and genome testing, I think by at least three times the next company. We have an army of sales reps who have been focused on that specialty setting. We're now assembling the general pediatric team to complement them.
We don't want to distract from our core growth today. We know that this is a different market segment. The sales team has been established and will continue to expand throughout 2026 with that team. We also know that simplifying the ordering experience for these clinicians is hugely important. Any general pediatrician has about 10 minutes with every single family that they're seeing. That's not a lot of time. We cannot encumber that time with an arduous workflow. What we're designing is one-minute ordering. I think sometimes we forget that clinicians are consumers as well. We're all much more programmed for rapid ordering. We're building what that workflow looks like today. We will be bringing that online in 2026. To inform that, we've actually started working with general pediatricians. We wanted to put the customer in the middle of the design process.
We have an early access program that we've assembled with general pediatricians, both community and academic, both those who have ordered testing in the past and those who haven't, in order to make sure that what we're designing is satisfying their needs. The early feedback is that we're on the right track with this ordering process that will unencumber as much of the workflow from the clinician as possible.
If you juxtapose sort of the size of the opportunity there, for 20 years, GeneDx was calling on expert and still is expert geneticists in the United States. There are about 2,000 of those practicing clinically. It has been two years since we began calling on the first of what over time will be additional specialty types, that being the pediatric neurologist. There are about 2,000 pediatric neurologists in the United States. As Katherine said, with 60,000 pediatricians and about 25,000 of those seeing patients with global DDID, that presents an opportunity for something like 10X the number of physicians for us to go out and engage with over time.
That pilot program, are you able to say how large it is? You said it's a mix of community and other physicians?
Yeah. It involves several dozen general pediatricians. We are getting that kicked off the ground and getting their input. I think something that is also interesting that we have learned through some of the market research that we have done, the role of the parent, of course, is hugely important. The absolute best advocate for every child is their parent. Continuing to educate parents to really drive some of the behavioral changes that we want to see in terms of clinicians using this testing is an important element of this. We have also further substantiated our market leadership with some market research that said that for pediatric specialists, GeneDx by far is the number one brand. Beyond the genetics experts, where we enjoy 80% market share, the market amongst pediatric specialists also tells us that we are their number one choice.
You guys have done a good job bringing down denial rates. How are you thinking about it in the ped market as you enter there?
Yeah. We've been able to systematically improve payment rates over the last couple of years. We'd expect a lot of that effort to continue. In the underlying core business, might expect to continue to elevate up average reimbursement rate by further reducing denials. At the same time, if you look at some of the new specialty types that will be launching in 2026 and beyond, and when we begin to see volumes come through general pediatrician, there's some unknown on how payers might react to seeing volumes come at large scale from a new ordering physician type. If you look at underlying reimbursement policy, there's no reason per se that tests coming from a general pediatrician in most cases would be denied for that reason.
It is also why we want to caution that time period of close to 18-24 months from the time those guidelines dropped in June. That allows us to not only educate physicians, it allows us to not only build the customer experience, but engage with the payer community to ensure they are ready to see what we expect to be a large volume of demand coming from general pediatricians. That work is ongoing. It may mean as we launch into new call points, whether it is the general pediatrician or additional specialty types, there is some sort of transitory period where payment denial rates could bounce around. You would expect a slightly elevated denial rate at the onset of orders coming from a new doctor type. Then we go through the work to educate physicians that that demand is real, the benefit is there, and combat those rates down.
At this point, we'd expect the average reimbursement rate in the third quarter is about $3,800 a test. Fairly stable environment there with a lot of puts and takes both up and down as we move forward.
Maybe we could shift over to NICU. This has been another initiative. You'll do 2,000-ish tests here in the back half of the year. Talk a little bit about, I mean, it's a small fraction of the market you're penetrating today. Talk about the strategy to kind of ramp that up. You've done a dozen or so Epic implementations. When do you see the lift from those?
Wonderful. The NICU setting is a hugely important opportunity for us in terms of our ultimate goal of earliest possible diagnosis. Today, the standard of care involves fewer than 5% of babies getting access to a genetic test. This technology is woefully underutilized in the NICU today. Through a research collaboration that we've done with Seattle Children's, we've published data earlier this year that shows that 60% of babies in a level four NICU will benefit from a genetic test. We've seen the benefit of broad testing in the NICU, both in terms of better clinical outcomes, but also in terms of health economics. The utilization of this testing actually helps save about $150,000 per baby on an annual basis.
Importantly, we've also established a financial calculator that really helps each individual health system see that they can continue to run a really healthy business by utilizing this testing. We have established both the clinical data as well as the health economic and financial evidence in order to convince the various stakeholders that they should utilize this testing. We began investing in Epic Aura earlier this year. We'll have 12 systems activated with Epic Aura. That's been another new muscle that we've built this year. What we're seeing when we activate a system with Epic Aura is because we're uploading our entire test menu compendium. We're seeing orders coming from the outpatient and from the inpatient setting. We're seeing both exome and genome volume coming through there. We're seeing some good volumes coming through Epic Aura.
We're also learning that some of our clinicians like our ordering portal as it is. As we have a dedicated NICU team going in there and selling testing through Epic Aura as well as through our existing ordering portal, we're making some nice progress there. I think as we look to 2026, we'll continue to invest in Epic Aura as a health systems approach, both for outpatient and inpatient. We really want to see the work that we've done at Seattle Children's continue to be the model of care. We're working on a Seq First consortium to establish that not only what we've achieved at Seattle Children's is driving better outcomes for these patients, but really using that as the foundation to say it's a better way of approaching overall pediatric care.
Maybe just thinking about the business here holistically and the migration, the whole exome, whole genome, you grew those volumes 33% this last quarter, 26,000. I think you previously said you expect the volume growth to come from a pretty even mix of provider growth, new providers, and new products. Talk a little bit about the evolution of each of those and how you think about overall mix for whole genome and whole exome evolving.
Yeah. I mean, if you look at the 33% growth in the third quarter, what was really encouraging is we're still seeing an increase in what I'll call same-store sales from the innermost core there of expert geneticists as they continue the evolution of putting down panels and moving to exome and genome. Even a market that for us in terms of physician count is fairly well saturated with 80% market share of all clinical exome and genome from experts, we're seeing something like a mid to high single-digit growth rate in expert geneticists, with all of the incremental growth on top of that coming from pediatric neurologists, seeing nice strong growth and accelerating growth from pediatric neurologists. If you look at the overall mix between exome and genome in the outpatient setting, exome remains the predominant test today in that outpatient setting. It's well understood.
It's well reimbursed. Turnaround times for us are best in breed. At this point, still see the majority as exome, but over time would expect a natural evolution from exome to genome across all physician types. Ultimately, we see the paradigm moving to a genome for all hereditary disease diagnosis. It will take many years for genome to completely phase out exome in that regard, but ultimately view that as inevitable. If you look at the new specialty types we'll be launching into, there's no reason that we would expect anything other than something approximating today's mix of exome and genome, but over the years, a continued evolution into more genome as the paradigm. Margins for us are attractive on either product.
The commercial team is incentivized to bring in either an exome or genome, either a significant upgrade over multi-gene panels, both good for patients and both good for our business.
You talked about more of the growth coming from pediatric neurologists. What percentage of mix of whole exome, whole genome are coming from pediatric neurologists today?
If you look at ped neuro, it makes up the majority of growth. The overall volume still has the majority coming from geneticists. We're about 14% penetrated in terms of the number of orders we'd expect to come through from ped neuro, with about a third of all ped neuros having an active account with GeneDx, not all of them up and mature. If you look at the base of the volume, the majority is geneticists, but outsized weight in terms of growth coming from ped neuro.
Maybe we can hit on ASPs. Over 3,800 netted denials showing good progress there and improving the take-pay rate. Talk a little bit about some of the drivers, how much of that is RCM activity versus some of the new state coverage coming in the mix. I think you added five states in the last year.
Yeah. It's an equal mix of RCM improvements across commercial payers. We're a network contracted 80% of commercial lives. For us, improving collection rates is really a matter of reducing denials and not winning any new contracts. We've had stable pricing across the commercial landscape in terms of list price. What we've been able to do is systematically reduce denials to the point where now we're getting paid on the majority of tests, about 55% of all tests being paid. That leaves opportunity to further improve that number over time and a lot of investments going into both technology and the team to do that. We'd expect to continue to reduce denials over time in the commercial landscape. On the Medicaid population, what's most encouraging is in the 35 states, which is now 36 states. A week ago, California picked up whole genome coverage for Medi-Cal.
That is to come in terms of collection dollars. If you look at the 35 states up to that point with coverage, we're seeing about an 80% payment rate, pretty clear medical necessity, administrative guidelines to follow, and an 80% rate I think we would sign up for any day. What, of course, brings down our aggregate payment rate is we're serving all 50 states, whether or not there's coverage. If you look at the Medicaid portion of the business, it's about 40% of all volume. We're being paid about 50% of the time, but that's solely a function of the states that we're serving that have yet to pick up coverage. We'd expect continued emergence of more and more states picking up coverage. It's somewhat out of our control.
From a guidance and a planning perspective, never assume that another state will pick up coverage. There's, I think, compelling reasons why we'd continue to see an evolution in that regard.
How about mix? Trios versus singles versus rapid? How much is that lifting ASPs?
About two-thirds of all cases we run are parent-child trios, and that's held consistent for well over a decade. No major changes there in terms of that mix.
What's kind of the right growth trend to put on ASPs over the next two to three years?
The average when-paid rate for us is something closer to $7,000 a test. I don't think it's reasonable to assume we'll ever get paid 100% of anything in the United States. We think a theoretical max of about an 80% payment rate is what we're targeting. That would say there's plenty of room for that reimbursement rate to continue to march upwards. As we talked about earlier, you might expect some headwinds in those new call points, physician types as we build up experience. All to say at this point, certainly believe the rate where it is today at around $3,800 on a cash collection basis is durable for many years to come.
There might be some puts and takes as we enter into some new markets where for some period of time we'd see a higher denial rate and then have to combat those down over time. The rate could chop around a little bit from this point, but certainly view today's rate or higher as durable for quite a long period of time.
It's a good segue into margins. You've been on margins this quarter as well. I think you're now expecting 70-71% gross margins, up 600 basis points or so. In addition to the ASP runway, you've done a lot on COGS. Talk to maybe some of those initiatives around automation. We haven't touched on Fabric, but how is that kind of impacting margins as well?
Yeah. We continue to see the cost curve come down for both exome and genome. At this point, exome far more optimized in terms of its COGS profile than genome. I think if you look at the COGS stack, about a third of all costs are reagents, consumables, and we might expect to see those continue to come down over the next several years. About a third of all costs wet lab labor up to the point of producing the sequence. Those costs fairly well optimized at this point. Our laboratory is running higher volumes than any other commercial lab in the United States, if not the world. An extreme economy scale advantage, full-scale robotics, automation in the lab. That has led to pretty consistent COGS reduction over the past couple of years. I'd expect those reductions in terms of wet lab performance to level out over time.
Where there's still tremendous opportunity is about a third of the COGS stack is labor cost after the sequence is produced. Analysis, interpretation, abstracting of medical records, curating that data in the dataset, writing the report itself, 100% of all samples we produce today are touched with human intervention. I think a pretty exciting roadmap the team is focused on over the next several years to introduce language models, AI, and other techniques in order to further automate. I still continue to believe there's further reductions in the cost curve to come for us over time.
Maybe just to wrap up, OpEx, you took that up in the third quarter. Obviously, a lot of that's the investments we've talked about, particularly around the guideline push. You are drawing a line in the sand on maintaining adjusted profitability in 2026, but street numbers are pretty dispersed on that. Maybe just talk about the gives and takes on investing and how you really do think about that path of profitability.
Yeah. I think overall that commitment is there to stay EBITDA positive on an adjusted basis. Look, we've got some exciting growth curves ahead of us. Those additional specialty call points, the introduction of a new customer experience in general pediatricians to target general pediatricians. I think now is the opportunity to lean into investing in future growth vectors for the company while at the same time we want to thread that needle to stay profitable and generate cash flow and then invest those incremental dollars back into the business. We have our eye on growing aggressively while also maintaining discipline in that regard.
Great. For our time, we'll leave it at that. Thanks.
Thanks so much, Tucker.