The last day of the Jefferies 2023 London Healthcare Conference. I'm Brandon Couillard. I cover the life science tools and diagnostics sector here at the firm, and we're really excited to have Guardant Health with us at the conference for the first time this year. Here to share an update on the story, our Co-Founder and Co-CEO, Helmy Eltoukhy.
Great. It's great to be here presenting the Guardant story. So here's... We'll make some forward-looking statements. Here's our safe harbor statement. So we started Guardant about 11, 12 years ago now, really with this idea of giving patients more time, more time free from cancer, more time with their loved ones, with their families and friends. And we developed a technology that really pioneered the liquid biopsy space in terms of the ability to take a tube of blood and really extract as much information from it as we can, and it really centered on essentially cell-free DNA or DNA that's being shed from dying cells in the body and mostly cancer cells in the body.
We developed a new chemistry that allowed us to extract that DNA with extremely high efficiency, employed next-generation sequencing techniques, and really used a powerful new informatics platform to be able to learn how to extract those signals with very high fidelity and high sensitivity, and use the fact that we were acquiring a lot of data to aggregate that data and make the algorithms better over time. And then this is really the sort of core of what we do at Guardant. This allowed us to unlock three major verticals in cancer. Really, the idea of therapy selection, where we started with, we launched the first test in 2014. That's a $10 billion total addressable market in the U.S., with close to 1 million advanced cancer patients, over 700,000 advanced cancer patients.
Now, that test, the Guardant360 franchise, is the leading liquid biopsy in the United States and soon to be globally. The second vertical is minimum residual disease. It's a $20 billion opportunity. There are over 15 million cancer survivors in the United States, and so these are individuals that had early-stage cancer and were cured through either a resection or sort of associated adjuvant therapy. The idea is to monitor those patients with a blood test for recurrence of disease. The largest market opportunity is screening, which is a $100 billion U.S. market opportunity. There are over 120 million individuals who are average risk in the United States that, you know, are should get annual or semi-annual testing in terms of early detection of cancer.
We just finished a very large trial, and we think we'll have the first FDA-approved, Medicare-reimbursed liquid biopsy for screening sometime next year. Today, Guardant is gonna do at the midpoint $555 million of revenue. We have over 160 biopharma partners. We've been ordered in over 60 countries, and we have over 600 global patents and patent applications. And so we've really built a robust company that is fueled by this innovation engine. So let's dive a little bit deeper into therapy selection. As I said, it's about 700,000 U.S. patients, probably close to 10 million globally, if we take that to the global scale, and $10 billion total addressable market just in the U.S. So why is therapy selection with liquid biopsy so important?
This is a study that just came out in the Journal of Clinical Oncology, which essentially showed that if you're able to essentially understand what's driving the tumor genomically through our blood test before picking an associated therapy, patients do about four times better, and this is overall survival. So they live four times longer by having the right information up front. And so this is really how powerful this type of testing is, and why it is increasingly a standard of care for most cancer patients today. We have four tests in the therapy selection franchise: Guardant360 CDx, which is the first FDA-approved comprehensive liquid biopsy. We have Guardant360 which is a next-generation version of Guardant360. It's a much larger panel.
We have Guardant360 Response, which, not only can this testing tell you what drug to, apply to the patient, but a second test just a few weeks after drug initiation, therapy initiation, can tell, the physician if the drug is working or not. And so it can be used to not only select drugs but monitor drug efficacy and we have a Medicare reimbursement for that in the immuno-oncology space. And then finally, Guardant360 Tissue. This is a complement that allows a physician to use the tissue biopsy to get some of the genomic information. Guardant360 really has been the sort of engine that has fueled our growth.
We're seeing 44% CAGR in terms of clinical volume testing, and we see that, you know, sort of, those volumes continuing to grow very nicely. On the biopharma side, as I said, we work with over 160 biopharma companies, and they use our testing for enrolling patients to their clinical trials or really understanding what is sort of important about a drug to design next generation versions of those drugs, and that's been growing at 26%. And so we see therapy selection utilization continuing to grow due to a number of reasons. We see, we're still in very early innings in terms of adoption of both liquid and tissue testing.
Biopharma is obviously driving $10s of billions of research in terms of new use cases, new biomarkers that need to be tested, and so that's fuel that's further driving, you know, future growth. And then we see comprehensive profiling. Right now, it's really confined to the late-stage setting, but we see that eventually going earlier into the pipeline, having earlier-stage patients really comprehensively profiled as therapeutics move earlier in terms of the treatment trajectory. We've built a best-in-class commercial team in the United States with number one-rated field team, number one-rated support, number one share of voice, both remotely and in person. Therapy selection business has multiple drivers that'll continue. We're seeing a really nice portfolio in ASP increases, so increases in Guardant360, sort of ASP.
We see future CDx approvals really driving future growth. We saw with our ESR1 approval earlier this year, that really driving a tremendous growth in our breast cancer testing business, and we see those sort of catalysts happening in the future. We're seeing very nice growth with the Guardant360 TissueNext and Response because of the fact that they can attach and essentially follow from our Guardant360 business. There's a lot of international market expansion that's happening, we're very excited, you know, about, as well as market expansion in terms of going towards, you know, earlier lines. And then we have our Smart Liquid Biopsy platform fueled by Infinity that has been driving great growth with our biopharma segment this year.
Finally, we've built the business in the right way, and so our therapy selection business now is close to being a cash flow break even, because of the really nice unit economics we're able to derive from both the clinical and biopharma businesses. Let's shift gears and talk about MRD. Guardant Reveal is our flagship product for the MRD segment. It's the only product on the market today that doesn't require a tissue biopsy. There are a lot of products in the market where you need to have a tissue biopsy from the patient, you need to sequence it, and then you need to design an assay to follow those patients. This is a test that is a true liquid biopsy.
You can essentially just a simple blood test can be drawn, or a simple blood draw can be obtained from the patient, and it can give very high performance in terms of really detecting recurrence early. This test right now is available in colorectal cancer, breast and lung cancers, and we are on track to upgrade this test to the next version, which we call a Smart Liquid Biopsy platform. As I said, it's a $20 billion market opportunity, 15 million+ patients, and right now it's in very early innings in terms of only less than 3% of it is sort of penetrated at this point. We think the future of MRD testing is tissue-free.
If you think about those 15 million cancer survivors in the U.S., many of them are years out from surgery, and so being able to access those patients or access those patients' archival tissue is very difficult. And so we see a lot of advantages to the tissue-free approach. It's faster, you don't need to design an assay, which can take three to four weeks, and so we can get you a result in seven to 10 days. It's easier. Obviously, you can access all those patients, as I said, that are years out from surgery, and it's more powerful. We can see the cancer as it changes. Many of these patients, a primary tumor may be cut out, but there may be micromets that have different genotypes that cause that recurrence, and we can see all of that.
This is a market that needs a lot of investment in terms of truly making a business. As I said, our Smart Liquid Biopsy platform allows us to track thousands of essentially methylated alterations in a tumor, rather than just looking at 16 or 48 or 50 mutations, like some of the tumor-informed approaches do. We have a very robust clinical validation pipeline with over 18,000 patients and close to 80,000 samples that are in the pipeline to be able to validate our Smart Liquid Biopsy platform. Just like we did with our therapy selection business, we're doing this in, I think, a sort of very bottom-line conscious way in terms of really engineering the demand and increasing testing utilization concurrently with reimbursement checkpoints.
As we obtain additional reimbursement and improve ASP, we'll be increasing the volume in a sort of likewise fashion. And then finally, the largest category, screening. As we know, early detection makes a big difference in terms of cancer outcomes. With metastatic disease, there's only 14% survival. With local disease, you have 90% survival rates, and regional disease, 65%. And so what's been the challenge in terms of getting patients screened? Unfortunately, a lot of the existing screening methodologies have a sort of what's called unpleasant consumer experience, or are low performance if they're multi-cancer in terms of early detection. The goal really is to detect cancer as early as possible, and you need high sensitivity in the stage 1, stage 2 setting to be able to do that.
Just to give you a sense, in the U.S., there are about 50 million unscreened individuals for colorectal cancer. And so there are about 50,000 deaths per year. And so this number is, it was very interesting to me, which is that 76% of deaths from colorectal cancer come from those 50 million unscreened individuals. And so screening works. You can see that, you know, we're reducing the colorectal cancer rate of colorectal cancer death considerably by screening. But it's a matter of getting those unscreened individuals finally screened, which will make a huge difference in terms of decreasing death rates from cancer.
We finished a 20,000-patient trial called ECLIPSE, that read out positively with 83% sensitivity compared to colonoscopy for detecting colorectal cancer with 90% specificity, which compares favorably to other first-line screening methodologies. And so right now, this is been submitted to the FDA and is under review. We think blood, I think, is underappreciated in terms of how immensely it'll address this unmet need. We see, in terms of the surveys we've done, that seven out of 10 patients who've had a stool test, for instance, would not choose to do stool again, which is one of the reasons you have this high churn rate that exists with existing screening methodologies.
Five-to-one patients prefer blood over stool, and from what we've seen with our own data, we've launched Shield as an LDT now for over a year. We're seeing well over 90% adherence rates compared to 60%, you know, plus for stool type testing and even less for other methodologies. And so, as I said, we've submitted to the FDA. We believe we'll get approval in 2024, and from there, we would be the first FDA-approved, Medicare-reimbursed test. There is a national coverage decision that's just sitting there that would essentially apply to this test once it's approved.
And then within another couple of years, by driving the guidelines, the USPSTF guidelines, we'd be able to have 100% coverage with $0 copay, for this test, which is, really, one of the largest opportunities that exists in, in the diagnostic space. So what's next? We have, you know, Shield, which will initially target colorectal cancer screening. We have a 10,000-patient lung study that is enrolling very nicely. And so that same test will be upgraded to look at both colorectal cancer in the high-risk lung cancer patients. These are, individuals that are 20-pack per year, smokers. And then, the next step after that is to upgrade the test to multi-cancer to look at a whole, panel of, many different cancers. Maybe shifting gears towards, revenue.
We reported Q3 results a few weeks ago, and we had $143 million, which is 22% year-over-year growth. That was really fueled by a precision oncology growth at 31%. Our clinical testing and biopharma testing has been growing very nicely at over 30% year-over-year. We raised guidance as well for 2023. We are now expecting to do $553 million to $556 million of revenue this year, which would correspond to 23%-24% year-over-year growth. We are on track for our operating expenses to be lower than 2022, and also on track for reducing our cash burn to around $350 million.
We're also on track in terms of all the goals that we set out to achieve this year. In therapy selection, we've hit all our goals in terms of obtaining reimbursement for Guardant Response, EMR integration, reimbursement for 360 in Japan, and exceeding 200 million covered lives for TissueNext. We are on track to hitting all our goals for MRD and recurrence monitoring. We were able to obtain a commercial reimbursement for Reveal from a couple plans. We presented additional data types for CRC and for Guardant Reveal and CRC and other tumor types. We are on track to upgrade that to our Smart Liquid Biopsy platform. We've completed FDA submission in March for our screening assay Shield.
We think we'll hopefully, in the coming weeks, have a sort of seminal sub-publication around the ECLIPSE study published. And we are also on track to have a readout late this year, early next year for our lung cancer assay as well. Thank you.
Thanks Helmy for being here.