It's a hardy group that's here at 8:01 A.M. I think there'll be a bigger group at about 8:05 A.M., but we'll go ahead and get started because I have a lot to ask. Excited to be here. Thank you guys all for being here. For anyone that doesn't know me, my name is Eve Bernstein. I cover U.S. life science tools and diagnostics here at Bernstein, and I'm really happy to be joined by Dr. Joshua Ofman, current—let me start actually with all of the hats you've worn at GRAIL over the years. You joined in 2019, and have held key leadership roles: Chief of Corporate Strategy and External Affairs, Chief Medical Officer, Head of External Affairs, and then assumed the role of President in 2021. Did I get it all right?
Got it all right.
Awesome. And before that, 15 years at Amgen. Like I said, I have a lot of questions. I'm really excited to jump in. A quick reminder to everyone in here that you're welcome to ask questions. We have the Pigeonhole app open, and I'll be monitoring here. Feel free to ask away. With that, let's get started. First, let's start with just, you know, state of where we are right now. Growth had really strong growth so far in 2025. What do you attribute that to the most? What do you think the biggest drivers have been, you know, a mix of provider contracts, employer adoption, partnership with Quest? How do you kind of think about all of those and which do you see as the most sustainable drivers going forward?
Yeah, it's a great question. Thank you for having me, by the way. It's great to be here. We're excited with the momentum in the market. We've been building the market now for several years, and we're getting good momentum. As we've said in our earnings call, we're on track to hit 20% to 30% growth in revenues. First half of the year was great. We hit about 22% growth in revenues and about 30% growth in utilization, which is terrific. We're seeing good growth and good momentum in all of our channels. The largest channel obviously is the clinic sales channel, self-pay channel, where we're getting great uptake and momentum both in the breadth of prescribing as well as in the depth and the repeat prescribing, which we'll talk about.
Mm-hmm.
You know, in the employer channel, obviously a lot of interest in the life insurance channel to provide health benefits to people who care about being very proactive with their health. As you can see in healthcare, there's now a big movement broader in healthcare towards wellness, more proactive healthcare. That's gelling very nicely with what Galleri is trying to do with people who are trying to be very proactive. Our partnerships, like with Quest Diagnostics, are really important. Quest provides very easy access now for physicians to prescribe Galleri when they're on the Quest EMR. Even in other health systems that have different EMRs, they're often linked up with Quest EMR. It just provides a frictionless way for doctors, and it makes it easier.
You talked about great growth on the sort of self-pay, but I'm going to start with reimbursement because, you know, when you think about long-term growth, that's often a key. We've seen a lot of versions of the Medicare Multi-Cancer Early Detection (MCED) Act making their way through various parts of the legislative body at different times. How do you view the legislative pathway from here?
Yeah. I think what many people don't realize is by statute, Medicare does not have the authority to pay for any preventive care. The only reason Medicare is able to pay for mammograms and Pap smears is because special laws have been introduced. There's an enormous group of stakeholders in DC who care a lot about cancer and who care a lot about cancer screening. They've worked really hard with lawmakers to create this new legislation, which is the Medicare Multi-Cancer Early Detection (MCED) Act. It's currently the most supported healthcare bill in all of Congress. It's got bipartisan and bicameral support. If passed, it will give Medicare the statutory authority to provide coverage for MCED tests that are FDA-approved. That's really critically important. It will only provide that pathway for Medicare for FDA-approved products. It just got marked up in the House Ways and Means Committee.
Last week there was a hearing in the House Energy and Commerce Committee. Those are two of the committees with jurisdiction over Medicare, and it went very well. There's good momentum in DC right now. I know the stakeholders are just looking for that vehicle, that legislative vehicle to attach it to. They're pretty optimistic.
You mentioned that it's got bipartisan support. In the past, there have been other versions of similar bills that have been introduced and have also had bipartisan support. Do you think that this time is different? I know it's hard to speculate, but I guess how do you see this current administration, this current Congress? Do you think they're more or less supportive? How do you compare and contrast versus what's happened in the past?
You bring up a great point. There have been other opportunities for this bill to get passed. Last year was a good example, but the politics of passing these bills sometimes get in the way. There are times when you've got a great bill and all the right things are attached. Last year, for example, you know, they put their thumb on the scale and said, "This needs to be a much skinnier bill." They skinnied it down and there was no healthcare in the bill. There are a bunch of healthcare things that have to get passed that need to continue, the payments for the doc payment fix. You can go down the road, there are ACA issues. There is a bunch of stuff that has to get into legislation. There has to be a vehicle for the healthcare stuff to get in.
If there is that vehicle, the MCED bill is the most popular healthcare bill. We are very confident that it'll get in there. What the politics do in terms of how skinny or narrow any bill is unknown. I must say that the Trump administration does have a focus on this transition of healthcare from a break it and fix it healthcare system to one more focused on prediction, prevention, and early detection, particularly where AI is involved and how healthcare can move in that direction. You've heard that from his administration for over a year now.
Yeah.
It does fit nicely, but the politics, you know, ultimately in the end around how big the package is, is what's going to matter the most.
It's not something we can control.
That's right.
Fair enough. All right. Let's move to competition if we could. The field is evolving quickly. You guys had a blog post in July where you emphasized that MCED tests have to demonstrate performance in their intended-use populations, not just enriched trial settings. Can you talk a little bit about why that distinction is so critical and how you expect the MCED field to play out over the next few years?
Sure. We've been out there for several years now trying to build this market. It's a brand new market. It's an enormous paradigm shift from screening for one cancer at a time to now having multi-cancer early detection tests like Galleri that can detect well over 50 types of cancer at once. That's a big shift. We welcome competition to help us build this market. We've been kind of like waiting. Where, where, when are they coming? Some of them now are arriving. The challenge is, to put a test like this into clinical practice, you want to know whether the performance is good. That can be done in retrospective case-controlled studies and show that the test actually can detect cancer. Then you need to really study it in actual people who are getting screened, who you have no idea that they have cancer.
That's what we call the intended-use population, a population of adults who are getting screened for cancer. Too often we have seen these small case-controlled studies show unbelievable performance only to be put in an actual population and barely work at all. We've seen that with ovarian cancer screening tests. We saw this with the DETECT-A study, the CancerSEEK test. Before Exact Sciences had bought it, they bought Thrive. There was a case-controlled study that showed unbelievable performance. They put that assay into 10,000 women over the age of 65, and the blood test barely worked at all. We've seen that time and time again. We don't think it's appropriate to introduce a test into clinical practice until they've shown demonstrable, good, solid performance in the intended-use population. In fact, we would not launch Galleri until we did that.
We did the prospective interventional Pathfinder study, and until we saw those results, we did not launch Galleri into clinical use. We think it's critically important because the safety issues are really important. If one of these tests that doesn't perform well causes safety problems, the whole field could take a hit, right? We're building this field, and the last thing this field needs is a real poorly performing test out there that could do harm to patients.
That's the blessing and the curse of an expanding market. Maybe on that point, as you think about the other players that are out there, you know, Exact Sciences' CancerGuard test is now on the market. Investors are expecting a launch of Guardant Health's MCED test. They have their investor day today, so we'll see what they announce in the next couple of hours. How do you view Galleri's positioning relative to these products clinically and commercially? I'm sure the data is a big part of that. What do you think is the most enduring over time? How do you, what do you hear from providers about their reception to these tests?
I think it's really important to just take a look at the first fact. You know, what is the evidence that these tests have? First, you got to remember Galleri is the only MCED test that has been fully validated in the intended-use population. We've seen none of that data from any of these other test developers. We know that one of the most important elements of an MCED test is to have a very low false positive rate. Galleri's false positive rate is 0.5%. CancerGuard, their false positive rate is 2.5%. That's five times higher false positive rate than Galleri. When we're talking to doctors and we're talking about what's the thing they're worried about the most, it's how many false positives are there going to be? Even though there's a small change in specificity, our specificity is 99.5% and theirs is 97.4%.
That doesn't seem like a big difference. If you look at the false positive rates, which are the inverse, it's 0.5% versus 2.6%. That's an over five times difference. That's just an enormous burden. That translates into a very low positive predictive value. What Galleri wants is a test result that can be trusted. That's what GRAIL wants Galleri to be, the test result that you can trust. If you get a positive result, do you trust that result? With Galleri, you have a positive predictive value. That means if a test is positive, what's the likelihood you have cancer? It's well over 40%. You're going to see data next month that's substantially higher than that. If you look at a test with a false positive rate of 2.6%, that PPV is going to be half or more of what Galleri's is.
That's not going to be a test that you can trust, that result. That's really what we're looking at. The second thing that's really important about MCED tests is how much more cancer are they finding in the population. We call that the cancer detection rate. In Pathfinder, our interventional study, when you added Galleri to standard of care screening, and remember we only screened for five tests, we more than doubled the number of cancers you found in the actual screening population. Half of those cancers were in early stage one and two. That's the big public health benefit of adding Galleri. That's a clinical utility measure at the population level. How much more cancer are we finding? How much more in early stages? None of these other tests have any of those data.
When we talk to doctors, you know, they feel very comfortable with the database we have. We have one of the world's largest clinical genomics databases. We have one of the largest clinical development programs ever undertaken, and our data right now are just unmatched in terms of performance. I think that's what doctors want. They want confidence, and they want to trust those results.
How would you respond to, we've heard other companies that have sort of upped their sensitivity and decreased their specificity? Their claim, their argument is, you know, first of all, that NCI has supported that in discussions that they've had with them about the Vanguard trial and sort of planning. Second, that it's a trade-off, right? There are benefits to it as well. How do you respond to that?
It's a very simple response. First of all, there's nothing the NCI can say about Vanguard because the study hasn't even been conducted yet. That's, I think, all smoke and mirrors. The most important thing is to look at the actual data. Even at their lower specificity, higher false positive rate, our sensitivities are very comparable, particularly for the most aggressive, deadly cancers. Our sensitivity for stage two cancer detection, these are localized solid tumors, for the deadliest cancers is upwards of 70%. Our sensitivity compares very well with theirs. This storyline they're trying to tell about, yes, we have lower specificity, but we have higher sensitivities, is just not so. By the way, if you look at our sensitivity at their specificity, because that is the trade-off, our sensitivity is much higher. You have to look at the data appropriately.
You can't just compare sensitivity numbers when they're at very different specificities. When you talk to doctors about what matters in multi-cancer early detection, it's the false positive rate, the PPV, and the cancer detection rate. Sensitivity, of course, is important, but remember the current sensitivity for finding asymptomatic cancers in cancers we have no screening tests for is close to zero right now. If we're getting 40%, 50%, 60%, 70%, it's an enormous benefit.
Fair enough. Looking ahead to your registrational data, and you talked about some exciting data coming out in the next month or so. We know top-line performance has been very strong. What specific, more detailed data points do you think investors should watch most closely for in that readout? Looking ahead to 2026, same question for the NHS-Galleri trial.
There are two large pivotal trials. There's the NHS-Galleri trial, which is the only randomized controlled trial being conducted of any scale for an MCED test. We've just read out the first year of that, and that's going to be part of our FDA submission package in the first half of 2026. We've just read out Pathfinder II, which is the largest U.S. interventional trial of an MCED test. What the investors ought to be looking for as we read these out is, number one, what was the cancer detection rate? How much more cancer was found when Galleri was added to standard of care screening? Is that a doubling like we saw in Pathfinder, or is it substantially higher? Because now we're doing this test in a much broader representative population with much less healthy volunteer effect. That's going to be really important. That's the population health benefit.
Then you want to look at the specific performance characteristics. What was the false positive rate? What was the PPV? Again, the PPV is the one that means, can you trust this result? I think what you're going to see in these new readouts are substantially higher PPVs than you've seen before, which is already probably double the PPV that you're going to expect with Guardant's test or Exact's test. I think you should look for those numbers: the cancer detection rate, the false positive rate, the PPV. Obviously, one of the most important aspects of Galleri is it returns a prediction about where in the body that cancer signal is found. We call it the cancer signal origin prediction, the CSO. That is a highly accurate prediction, and you want to see that accuracy replicated in these large trials.
I think those four things to me are the ones to really look at. Obviously, you'll get a sense of sensitivity as well, and you're going to want to look at that too. The ones that seem to be the most important for an MCED test are those.
In the United States, what gives you confidence that the data that you read out will be viewed by the FDA as sufficient for approval? Can you give us a sense of timeline?
Yeah. We expect that our fund, we've been in a modular submission now for several years. We've been interacting with the FDA regularly. They've reviewed all of our trials. We've gotten investigational device exemptions from them. They know a lot about our assay and our test. Keep in mind, they've never reviewed an MCED test before. They don't have any guidance or pre-specified criteria. They'll be doing this for the first time. What gives me confidence is just the tremendous performance that we're seeing from this assay. The safety is incredible in all of our readouts so far. The performance is something that's never been seen. We're operating at PPVs and specificities and false positive rates at an order of magnitude better than anything that's ever been seen before with cancer screening tests. Remember, single-cancer screening tests focus on sensitivity.
You don't want to miss anything, but they accept very high false positive rates. You can't operate that way with an MCED test where you're looking for 50, 70 different types of cancer types. You have to have a very low false positive rate. That's what we're seeing, and it's translating into a very high PPV. What gives us confidence is the performance, the fact that it's been replicated from study to study to study, the fact that we're seeing similar performance in our real-world experiences, and the fact that other institutions like Mayo and Dana-Farber and the VA are publishing their experience and the data look even better than what we're seeing in our trials. That all gives us an enormous amount of confidence.
Fair enough. Maybe that was a U.S. question. Let's turn to the UK, actually. I would argue that the NHS is different from Medicare, in that they are more comfortable assigning a cutoff to what they are willing to pay for, and they usually use, you know, an incremental cost-effectiveness ratio or an ISR, or, you know, a QALY, something like that. I want to just dig into this a bit. Their threshold, their ISR threshold is typically £20,000 to £30,000. That's like $25,000 to $40,000. They do say, you know, they'll make exceptions. Not hard and fast, but that's kind of what they've outlined. What we know from an abstract from ASCO GI earlier this year modeled the ISR for Shield, which again, not your test, but they modeled it close to $50,000 or above the willingness to pay.
First, as we think about the readout next year from that study, is it fair to assume that you think the readout will include some assessment of ISR?
We're not doing a cost-effectiveness assessment in the NHS-Galleri trial, but we know that there will be a separate assessment of that done in the NHS. There will be an economic analysis done, but it's not actually part of the trial. It'll be modeled, and it'll be done separately. We expect that to be done. We have every expectation that Galleri is going to be shown to be a highly cost-effective intervention. We've modeled it extensively already using all the data that we had available to us, using U.S. thresholds, which are very different, more like $100,000 or $150,000 per quality-adjusted life year saved. We fall well beneath those thresholds. Highly cost-effective, and we're very comfortable that we will likely see that even using those other thresholds, that this is going to be a highly cost-effective intervention. Think about what we're doing.
We're dramatically increasing the number of cancers found in the population, half of them at early stages, which is a much lower treatment cost and gives people a much higher chance of survival. You're increasing those quality-adjusted life years at an important pace. That's what's really important.
You mentioned you'd done your own extensive modeling. Are you comfortable sharing where your estimates come out?
They've been published, and they're at least as good as the ISRs for single-cancer screening. Depending on the assumption that you make, and the paper has four or five different sets of assumptions, they can meet these thresholds. We need to see what the ultimate data readouts are and then model it based on those stats.
Do you have a sense of timing? I know you said that you're not involved in their economic analysis, but do you expect it to be done concurrently-ish?
We think it'll be done in sequence because we're going to read out the NHS-Galleri trial, the full three years, in the middle of 2026. Those data are going to go to the modeler. They'll need some time after that to do the model, probably towards the end of 2026, I would guess.
When would you expect the NHS to make some sort of decision or commitment about ongoing use?
They'll be contemplating that as soon as the data are read out. Once the data, because I don't think the NHS decision necessarily is going to wait for those economics to be done. I don't know, they may. We know that as soon as that final data readout is available, the NHS is going to begin their consideration process as to whether they want to roll out Galleri as a national screening program.
What about beyond the U.S. and the U.K.? We've talked about each of them pretty extensively. What other countries do you think have an appetite or a willingness to pay for a test like this, and how do you think about expansion beyond those geographies, especially beyond the partnership that you have in Israel?
First of all, we get a lot of inbound about distribution agreements and people wanting to work with us. We've gotten a lot of inbound from many European governments as well. I think you can, the way to think about this is if you're a single payer like the NHS in England, or, you know, think about the big European markets, Germany, France, Spain, Italy, those markets are really amenable to a test like this. This test can provide high-value population-based impact that can save them, you know, life years and dollars over decades. When you have a captive population, the value proposition is much better for a single payer than it is for a payer in the U.S. where they only have their population for two or three years. It's a very strong value proposition.
We expect as soon as either the NHS adopts it or we get FDA approval, a lot of these big single-payer markets are going to want Galleri. We're looking to that. In the meantime, we're dealing with just distribution agreements in markets and countries that have expressed interest or that are coming to us saying, "Hey, we would like to bring your test to country A or country B." We're entertaining those to the best of our ability.
For some of those countries that you're talking about, you know, the big European countries, maybe Japan, as you said, there is an appetite to invest in screening. Probably the best comp that we see is colorectal cancer screening. Single-cancer tests, so very different. In many of those countries, they elect for FIT as a standard of care, not colonoscopy. There are different pluses and minuses, but one of the big considerations is just upfront cost. Can you give us a sense of, were you to expand internationally, what sort of price point do you think you'd be able to support? Can you really see some of those countries that haven't wanted to use something like colonoscopy as a frontline screening move toward a very valuable but still costly choice like Galleri?
You're framing a good question. The tension with screening is obviously around the initial budget impact or the initial expenditure versus what are all the long-term benefits. In many of these markets, I happen to be a gastroenterologist, so I know that in many of these markets, colonoscopy is both underutilized and very expensive. Moving to a FIT test is an obvious choice for population-based screening, saving colonoscopy for those who have positive tests. It makes a lot of sense from a budgetary and a performance perspective for them to do that. When you get into multi-cancer early detection, we think at the price points at that scale, if we get to the scale that we're looking at, we think it will be supportable from a value perspective and a budget impact perspective. We've done some of that modeling already. We'll have to see.
We think that we can get this to an affordable place at the scale that we need to be at, you know, to serve the global population. That is our goal at GRAIL. We want this to be a population-level multi-cancer early detection test. That's why we've made these enormous investments in data collection in the largest studies ever done. That's why we chose to do our randomized clinical trial in the UK in their healthcare system because many of the other Nordic, European, Asian markets look to that. We've made these enormous investments with the aspiration to get to population-scale screening. We know at that scale, we can get the price right. It needs to be at that scale.
Do you have a chicken-and-egg situation where, to get to that scale, you need a lower price, but you only get a lower price once you get to that scale?
No, we see line of sight. We have line of sight to getting there, and we know that we can make this work. We need the data to play itself out. We need the approvals to happen. We're already getting a lot of interest from many of these markets.
Okay. We've got about 10 minutes left. I have more questions, so I'm going to keep throwing them out. If anyone else from the audience has questions, please feel free to submit them via Pigeonhole. Slightly different question, still in the commercial vein, probably. In Q2, 25% of Galleri's volume came from repeat testing. How much of that is concentrated in certain demographics, geographies, the worried well, the, you know, affluent? Do you view that as sustainable or more reflective of early adopter behavior?
Yeah, it's a great question. I think that we are, first of all, we're very impressed that we've been able to achieve 25% repeat testing this quickly. If you look at analogs, like how long it took Cologuard and how long it took other screening tests, much longer than that. We're actually very pleased with that. We don't think it reflects any particular demographic. In fact, we don't think it's an early adopter phenomenon either because early adopters, you know, they adopted Galleri early, but then they weren't doing repeat testing right away. That took them some time. You've got to really have some experience with Galleri and then see some positive results and hear about all the cancers that are being found and really understand the biology of the cancer signal.
What we've learned at GRAIL by looking at this biological signal from cancers is that cancers are progressing through stages much faster than we've ever known before based on imaging. Given the speed of this progression, annual testing becomes really critical if you want to find early-stage asymptomatic cancer. Doctors are now beginning to understand that. They're seeing the data. Our education is working, and they're seeing the results themselves, which is really driving a lot of that repeat testing. We don't think this is a flash in the pan. We think this is incredibly impressive repeat testing rates. We're looking to take those even higher over time. Obviously, the three-year data, the three consecutive years of data from the NHS-Galleri trial will be a big part of that.
That makes sense. We've talked a lot about the governments in the U.S., U.K., outside. What about how are private payers and self-insured employers reacting to Galleri so far? What feedback are you getting from them on test performance, coverage criteria, how it's working for them?
Yeah, so it's really important to segment the payers very carefully because they're all quite different. If you look at self-insured employers, on some dimension, they're payers, right? They're paying the healthcare. We've gotten a lot of uptake and a lot of interest from self-insured employers. They want to provide this as a health benefit, a wellness benefit to their population. They actually have very few things they can offer adults that are 40 or 50 years old, right? This is a really good thing. We're getting good uptake, good momentum in the employer channel, self-insured employers. We also have life insurance companies, right, who are also paying for the test to give to their policyholders, not as an underwriting tool because we won't allow that, but as a wellness incentive. If you really want to take care of your health, here's the Galleri test.
We've found a bunch of cancers already from life insurance holders who were given the test by their carrier. Good momentum there. Those are all payers. Now, traditional commercial payers in the U.S. are different. There are large national payers, and they've been very clear with us that they're likely not going to think about Galleri until we get the FDA approval. They don't like to pay for new novel technologies until they have to. They're going to wait for that FDA approval. Regional health plans are a little more flexible, and smaller health plans are more flexible. In fact, we have some small and regional health plans who've provided coverage for Galleri, including Medicare Advantage. There's a few of those, but we know that uptake is going to take a little longer. They want to see more evidence of clinical utility.
They want to see the FDA approval, and we think that's really going to unlock the commercial insurance market. We already talked about Medicare.
We talked about Medicare. That's fair. Did I hold you to a suspected timeline for FDA approval?
Our latest thinking is, you know, we plan on submitting in the first half of 2026.
Right.
We expect, based on historical precedent, that it will probably be about a year to get the approval if they have an advisory board. Given the fact that this is the first MCED test ever evaluated, we're expecting that they might have an advisory board. I think a year after our submission is a safe timeframe to expand.
That makes sense. Okay. I saved it until the end, but this is probably a really rich area of discussion. How do you plan to leverage the massive data sets that you've generated? You've talked about the investments that you've made in large clinical trials in intended-use populations. How will you use those to further improve Galleri's performance? What role could AI play for you and your company going forward?
It's a great question. First, you got to remember we have an enormous head start on all the other test developers. We're years ahead, both in time and in scale of the data that we have. We are already, and let's remember, Galleri is an AI-based test. Galleri is, we look at this genomic signal, and it's a pattern recognition where machine learning algorithms identify this pattern of epigenetic changes that are abnormal in certain regions of DNA. That pattern is almost never seen in people without cancer, which is why it's so highly specific with such a low false positive rate. That's all AI-based. The value of this enormous data set is this flywheel effect that we've created. The more data we collect, the more we can train our machine learning algorithms on false positives, on false negatives, to refine the algorithms even more.
To not only detect the predicted origin of the signal, but is the signal there at all? What's going on right around the cut point? How can we refine that over time? That's an enormous advantage, and that's how we're using the data now in this flywheel effect as we get to new versions. Secondly, we're learning an enormous amount about cancer biology and shedding biology, which cancers are shedding DNA at what quantity, which are not, which will be able for us to further refine. What other things do we need to add to our tests over time? Are there other analytes that could advance this field? Are there other biofluids like urine, for example, that could be added to Galleri that could enhance our performance in other ways?
Having all this data is giving us the flywheel effect on the one hand, on the other hand, giving us enormous insights into cancer biology. I would say we are really rewriting the textbooks of cancer biology as we're looking at data for the first time, ever. Like these studies, let's remember these studies, these are population-scale studies. 30,000 people in Pathfinder, 140,000 people in NHS-Galleri. These are the first studies ever that have looked for any cancer. All the other big studies have been looking for one cancer. In fact, if you think about the big lung cancer trial of screening, they found a lot of lung cancer, but the number one cause of death were all the other cancers that they weren't looking for in that study.
Now, for the first time, we're going to see detection for all these other cancers, and we're going to learn a ton.
We're almost at time. We've talked about a lot of the, I think, really exciting parts of the Galleri story, but looking forward, what, if anything, do you think investors are still missing from the story today? Or what do you think is still underappreciated about GRAIL?
I think one thing that's underappreciated is just what a paradigm change this really is. The ability to move from looking at your one cancer to be able to look at you as an individual for whatever cancer you may be harboring, that is an enormous shift. I think the gravity of this change is underappreciated. I think this focus on sensitivity, we forget that the sensitivity for finding asymptomatic cancer for most of the cancers is almost zero. In fact, if anybody listened to the Energy and Commerce hearing, there was a patient up there who said something I thought was so profound. They were talking about sensitivity and specificity, and he stood up, you know, this was someone who was diagnosed with an MCED test, early pancreatic cancer, cured. He said, "Hey, I'm not a number, but I can tell you this.
The false negative rate for current healthcare is 100%. Like I was told by doctor after doctor after doctor that I was fine. Those are all false negatives. I wasn't fine. I had a pancreatic cancer growing in me." We have to remember what's actually happening in the status quo. Today, we have five screening tests. We're only finding 14% of the cancers. That is not going to do it. We're not going to bend the cancer mortality curve. Cancer is about to become the number one killer of men and women worldwide. We have to dramatically change the status quo. There is nothing acceptable about the status quo. By the way, those five cancer screening tests are only finding 14% of cancers. They're generating 8 million false positives to do that. The signal-to-noise ratio is like one to 40. That's not okay. There's nothing acceptable about the status quo.
I think people forget about that when they think about MCED tests and try to focus on its very specific performance. We're going to perform very well, but we're going to have a dramatic impact on that population picture I just told you about where there's nothing acceptable about the status quo.
I think we've got to leave it there, but that's a really energizing way to start the day. Thank you so much.