Hello, and welcome to the Guardant Health First Quarter 2023 Financial Results Call. My name is Lauren, and I'll be coordinating your call today. There'll be an opportunity for questions at the end of the presentation. If you would like to ask a question, then please press star followed by one on your telephone keypad. Please also kindly limit yourself to one question and one follow-up. I will now hand you over to your host, Alex Kleban, Vice President of Investor Relations, to begin. Alex, please go ahead. Thank you. Earlier today, Guardant Health Released Financial Results for the Quarter ending March 31st, 2023. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO, AmirAli Talasaz, Co-CEO, and Mike Bell, Chief Financial Officer. Craig Eagle, Guardant's Chief Medical Officer, will join for Q&A. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties as well as reconciliations to the most directly comparable GAAP financial measures are available in the press release Guardant issued today, as well as in our Form 10-K and other filings with the SEC. Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise. Information in this conference call is accurate only as of the live broadcast. With that, I'd like to turn the call over to Helmy. Thanks, Alex. Good afternoon. Thank you for joining our first quarter 2023 earnings call. I will start off today's call for providing an update on our progress so far in 2023 and go into more detail on our progress in therapy selection and MRD. I will turn the call over to AmirAli for an update on screening. Finally, Mike will provide a more detailed look at our financials and outlook for 2023. At Guardant, we have built one of the fastest-growing platforms in diagnostics, coupled with what we believe is the most exciting pipeline in the industry to fuel long-term growth. Today, we are the market leader in therapy selection and technology innovators at the forefront of MRD and cancer screening. All of this enables us to help patients at all stages of cancer live longer and healthier lives. In line with this, I would like to start off with a patient story. A 43-year-old woman with no history of smoking went to her physician with chest pain. A CT scan ruled out a pulmonary embolism but showed a 3.5 cm mass. Following additional tests, she was diagnosed with stage III lung adenocarcinoma. Further testing from other modalities indicated the tumor was negative for EGFR, ALK, and ROS1. A Guardant360 liquid biopsy revealed several somatic mutations, including a ROS1 fusion, making her a candidate for the targeted therapy entrectinib. Following treatment, her oncologist ordered imaging to confirm whether or not she was responding to therapy, which came back inconclusive. A Guardant Response test was ordered and detected no ctDNA, indicating she was responding to therapy. One year into treatment, she continues to do well with an over 50% reduction in the primary tumor mass and complete resolution of other nodules. Her story illustrates the power of the combined Guardant360 and Response testing regimen to assist doctors in making these crucial decisions to deliver better patient outcomes. Turning to slide four. We started the year off strong with our first quarter revenue growing 34% to $128.7 million. Guardant360 continues to be the main growth driver with increasing contributions from Reveal and TissueNext. Our team continues to focus on delivering superior execution, operations, and customer service. All in all, we accelerated our growth in the quarter amidst stable market conditions, driving market expansion in a backdrop of notable retrenchments by competitors. Turning to slide five. We are pleased to report that in mid-April, we received Medicare reimbursement for Guardant Response. This is our fifth assay to receive Medicare reimbursement. It is the first blood-only liquid biopsy for immunotherapy response monitoring, representing a major step forward for patients. The overall testing program will consist of a Guardant360 test at treatment initiation, followed by a Response test in the appropriate time frame. Our rate for Response has been finalized at $1,943. We are exploring an ADLT pathway for this test in the medium term, which should increase pricing further. Turning to slide six. After another record quarter in which we continued to significantly grow market share, we want to take a moment to spotlight our core therapy selection business. Over the years, we have built on the foundation of the first FDA-approved comprehensive liquid biopsy to create what we believe is the strongest platform in oncology diagnostics. Our entire therapy selection portfolio is now reimbursed by Medicare with reach to over 300 million covered lives when we include commercial payers. We have established ourselves as technology and market leaders with a greater than 300-person commercial team across clinical and biopharma, over 12,000 ordering oncologists, more than 150 biopharma customers, all supported by hundreds of patents and clinical publications. Achieving scale is not a long-term vision, but at our doorstep. For therapy selection, which represents more than 95% of our total revenue, we expect to generate more than $500 million in sales this year with clinical revenue growth of greater than 25%, gross margins above 60%, and reach cash flow breakeven in six to nine. Moving on to slide seven. Clinical test volume reached over 39,100 tests in the first quarter, up 45% compared to the prior year quarter. Guardant360 continues to be the main driver with continued strong growth in lung cancer, with a significant uptake in breast cancer following our CDx approval for ESR-1 mutations early in the quarter. Guardant Reveal and TissueNext added to the growth as we rapidly onboarded patients in MRD and also gained market share driven by the recent launch of our AI-powered Guardant Galaxy tissue offering. We continue to execute in building account depth with more oncologists ordering more Guardant tests again in the quarter. This is due in large part to the leverage we are gaining from past investments in EMR integration processes and systems. We saw a nice upward move in our Guardant360 ASPs, supported by mix and positive momentum from commercial payers. We are closing in on coverage from all major commercial payers in the U.S. for Guardant360, given the addition of UnitedHealthcare during Q1, Aetna and Humana expected in Q2, and others that are in advanced discussions. Our ESR-1 CDx has been a major driver and is helping us to address remaining coverage limitations. All of this is providing a tailwind for ASP. Turning to slide eight, we had another solid quarter of biopharma growth with volumes up 21%. Our partnerships continued to rise, and we have now converted more than 20% of our mix to Guardant Infinity, our epigenomic or smart liquid biopsy-based panel, and also continue to see strong utilization of Guardant360 CDx. In addition, we announced another ESR-1 collaboration and are on target to start seeing China sales ramp up later in 2023. Turning to slide nine, with our strongest quarter yet in breast cancer, I would like to highlight the transformational potential that our CDx can have for breast cancers that develop an ESR-1 mutation. Between 65% and 80% of breast cancers in women are estrogen receptor or ER positive, and up to 40% of patients with ER-positive, HER2-negative cases will develop an ESR-1 mutation, which qualifies them for a new class of targeted therapy. ESR-1 mutations can emerge months or years after initial tissue or liquid biopsy, demonstrating a real need for liquid biopsy testing. With six biopharma partnerships focused on ESR-1 already, this will be a key focus area for CDx programs where our partners can leverage Guardant technical and regulatory capabilities. I'd like to take a moment to thank our team, who work tirelessly to ensure we live up to our most important value, to put the patient first. Everything we do is led by that North Star. At Guardant, we have built one of the most transformative platforms in diagnostics, and we think extensively about how we get our work done more efficiently, from development through delivery, to fulfill our primary mission of helping patients. In line with that goal, we recently made some key additions to our leadership team in an effort to further improve our ability to operate effectively while balancing our need to innovate quickly. Ines Dahne-Steuber joined Guardant as our new Chief Operating Officer. Ines brings more than two decades of broad diagnostics experience, including overseeing operations for labs running millions of tests per year. Under her leadership, we will bring further efficiency, leverage, and scale to the way we operate as a company. Darya Chudova was promoted to Chief Technology Officer. With this newly created role, we are bringing together our research and development efforts for oncology and screening to leverage our products across a single platform and allow us to scale more quickly and efficiently. I look forward to their contributions and strategic leadership to help Guardant continue to scale for this next exciting chapter of our journey. I am very proud of our team and our products and look forward to the opportunities ahead. With that, I will now turn the call over to AmirAli to provide an update on our screening business. Thank you, Helmy. Turning to slide 10, we continue to make good progress in our screening business as we spearhead a new patient-preferred category in the screening market. Our PMA for Shield, for its first clinical indication of CRC screening, is now filed with FDA. The review process is underway. Shield demonstrated 83% sensitivity and 90% specificity in ECLIPSE trial in range with other guideline-recommended non-invasive CRC screening tests where performance ranges from 74%-92%. We believe this test performance not only is above the bar for FDA approval and Medicare coverage, but also meets the requirement for a robust commercial success post FDA approval. In addition, the real-world customer feedback from our LDT-ordering physicians continue to exceed our expectations and validates the value of incorporating Shield test into screening menus. Moving to slide 11. Just this morning, at Digestive Disease Week, the study investigators presented additional details and insights from our pivotal ECLIPSE study. We are fortunate to host a call with the trial investigators and other cancer screening experts to share their perspective on these results. The performance of screening tests in detecting early-stage CRCs is an important parameter. CRCs with stage I-III have a very high survival rate, with 72%-91% of patients surviving at five years post-treatment. For advanced stage IV CRCs, five year survival rate is only 14%. The sensitivity of Shield in detecting stage I-III was 81%. For localized CRCs, meaning no sign of spread beyond the bowel wall, which would likely be cured through surgical procedures, Shield sensitivity was 72%. For regional and distant cancers, where cancer has spread to nearby lymph nodes or to distant part of the body, Shield sensitivity was 100%. Taking a closer look by cancer stage, Shield detected 55% stage I CRCs, 100% of all CRCs stage II, 100% of CRCs stage III, and 100% of CRCs stage IV. based on this performance, we believe that as a longitudinal screening test taken every three years, Shield will detect nearly all CRCs at a curable stage and will save many lives. I want to take a moment to highlight a few notable details. Three CRCs were lost to clinical follow-up and could not be staged. As a result, they were excluded from the staging analysis. Shield detected two out of the three excluded CRCs. In addition, the study had five small T1 malignant polyps, which were excised during colonoscopy procedure and considered fully treated by their doctor, hence they had no further staging. For the purpose of the staging analysis, they were all considered stage I. of these, one was detected by Shield. Going back to the overall performance, we are confident the first generation of our Shield has everything needed to drive a major step change in lives saved and be the first commercially successful blood-based screening test for CRC. We believe the detection performance of 83% at 90% specificity exceeds the requirement for FDA approval and Medicare coverage, two critical hurdles for any test. This is a major victory for creating this new patient-preferred screening category. With Shield, Guardant has now set the performance bar for the future competing blood-based screening tests. We are excited to bring the first generation of Shield to market. We have a clear time advantage relative to our competitors in blood-based screening. This first-mover advantage in this new patient-preferred category will result in cost-effective commercialization activities post-FDA approval. The second major win provided by our first-mover advantage is the learnings we have already been able to gain from running our ECLIPSE samples. By completing our pivotal study well ahead of our competitors, we have a significant lead on further innovation and technology platform upgrades that we can incorporate into future generations of Shield. For ECLIPSE, the stage I cancers were predominantly malignant polyps excised during colonoscopy procedures that were not well represented in our development cohorts and have lower level of signals in blood. Since locking our PMA device last year, we captured more data through both commercial testing with Shield LDT and analyzing more screening relevant cohorts. I'm very pleased with the progress we have already made in upgrading our platform technology performance, powered by this additional data and insights. Based on this progress, we are working on developing the second generation Shield with the aim of improving very early stage sensitivity. Guardant has set the bar for that future tests will need to compete with, and that bar is already moving. Just like with Guardant360, we will continue to improve test performance to lead this new patient-preferred category. Turning to slide 12. The unmet need in CRC screening is a test that gets completed. Blood tests in clinical practice have demonstrated an adherence rate of 85%- 96%. For Shield, in real world experience with our LDT over the last 12 months, we continue to show adherence rates of more than 90%. The effective sensitivity of clinical tests is a function of both the test sensitivity and the patient adherence rate. Taken together, with 83% and 90% adherence, we are confident that Shield will contribute to detecting many more CRCs at a curable stage. Turning to slide 13. Going beyond the first indication of Shield platform in CRC, we are making good progress with our lung cancer screening trial. Shield Lung will pave the path for Shield to potentially be the first FDA-approved multi-cancer screening blood test. I would like to take a moment to talk about our milestone-driven investments and resource allocation for our screening program. We anticipate that the contributing operating loss from our screening pipeline will be less than $200 million for the next 12 months. With this level of investment, we will be ready for Shield IVD launch upon successful FDA approval, deliver the second generation of Shield with even better early-stage performance, and make significant progress on indication expansion to lung cancer. Future investments would be contingent on receiving FDA approval and then gated by ongoing commercial success and revenue milestones. With that, I will now turn the call over to Mike for more detail on our financials. Thanks, Damiano. Turning to slide 14 to review our financial results. Total revenue for the first quarter of 2023 grew 34% to $128.7 million, compared to $96.1 million in the prior year quarter. Total precision oncology testing revenue for the first quarter was $113.4 million, increasing 35% compared to $84.1 million in the prior year quarter. This increase was driven by strong year-over-year growth across both our clinical and biopharma businesses. Precision oncology revenue from clinical tests in the first quarter totaled $91.6 million, up 39% from $66.0 million for the prior year quarter. First quarter clinical test volume was 39,100, an increase of 45% from the same period of the prior year and an increase of 9% or 3,100 tests from Q4 2022. While Guardant360 continues to be the main revenue driver with continued strong growth in lung cancer and a significant uptick in breast cancer, we also saw more than 100% year-over-year volume growth in both Reveal and TissueNext. First quarter Guardant360 ASP was towards the top end of our expected range of $2,600-$2,700, supported by mix and positive momentum from commercial payers. Blended clinical ASP was approximately $2,340, which was slightly above the blended ASP in Q4 2022. As a reminder, blended clinical ASP will continue to be influenced by both the volume mix between Guardant360, TissueNext, Reveal and Response, as well as the mix of overall clinical volume between U.S. and international. Precision oncology revenue from biopharma tests in the first quarter totaled $21.8 million, up 20% from $18.1 million for the prior year quarter. Biopharma test volume was strong, with first quarter totaling approximately 6,150 tests, up 21% from the prior year quarter. Biopharma ASP in the first quarter was approximately $3,550, which was in line with our expectations. Development services and other revenue in the first quarter totaled $15.3 million, up $3.4 million or 28% from the prior year quarter, primarily driven by higher revenues and from partnership agreements in the first quarter of 2023. Gross profit for the first quarter of 2023 was $75.6 million, compared to gross profit of $64.1 million in the same period of the prior year. Gross margin was 59% compared to 67% in the prior year quarter. The change in the gross margin was driven by a number of factors. For precision oncology, the gross margin was 60% in the first quarter of 2023 compared to 64% in Q1 2022. This reduction was due to the change in mix between clinical and biopharma revenue, with clinical revenue growing faster than biopharma revenue, as well as the year-over-year change in blended clinical ASP from $2,450- $2,340 due to the increased proportion of volume coming from Reveal, TissueNext and Response. Development services and other gross margin was 48% in the first quarter of 2023 compared to 89% in Q1 2022. Roughly 1/3 of the decline in margin is due to a one-time cost incurred in Q1 2023 related to one of our partnership agreements, with the remainder of the decline due to the cost of processing Shield LDT samples as part of our market development activities, for which we are currently booking minimal revenue. Despite the factors influencing our gross margins, we still continue to expect overall gross margins to be approximately 60% for the remainder of the year. Operating expenses for the first quarter of 2023 were $209.7 million, increasing 12% compared to $187.5 million in Q1 2022. Net loss was $133.5 million or $1.30 per share for the first quarter of 2023, compared to $123.2 million or $1.21 per share in the first quarter of 2022. Moving on to non-GAAP financial measures on slide 15. As a reminder, non-GAAP financial measures exclude stock-based compensation and related employer payroll tax payments, amortization of intangible assets, contingent consideration, acquisition-related expenses, unrealized gains on marketable equity securities, and impairment of non-marketable equity securities. Non-GAAP operating expenses were $188.3 million for the first quarter of 2023, a 19% increase from $158.7 million in the prior year quarter. Non-GAAP net loss was $108.5 million or $1.06 per share for the first quarter of 2023, compared to $93.2 million or $0.91 per share for the first quarter of 2022. Adjusted EBITDA was a loss of $101.0 million in the first quarter of 2023, compared to an $86.6 million loss in the first quarter of 2022. We define Adjusted EBITDA as non-GAAP net loss, adjusted for interest, income tax, depreciation, amortization, and other income and expense. Taking a closer look at our operating expenses and cash burn on slide 16. We've made very good progress with respect to meeting our target of reducing both our operating expenses and cash burn for the full year 2023. As mentioned, non-GAAP operating expenses in the first quarter of 2023 were $188 million, and include approximately $8 million of one-time severance costs related to the recent workforce reduction. Excluding severance costs, this represents a reduction of approximately $21 million versus our non-GAAP operating expenses in Q4 2022. Our free cash outflow in the first quarter of 2023 was $82 million, which also declined in comparison to Q4 2022. These decreases were driven by efficiency measures implemented in the first quarter, including the workforce reduction, as well as by our ability to leverage the infrastructure we've built over the last few years. While both operating expenses and cash burn levels could fluctuate up and down throughout the year, depending on the timing of certain activities and cash outflows, we will continue to diligently manage our spend with the goal of lowering our full-year operating expenses compared to 2022 and reducing our free cash outflow to under $350 million for the full year. Turning to slide 17. As I just mentioned, we demonstrated leverage in Q1 from infrastructure investments made in prior years and the recent workforce reduction, as a result, ended the quarter with $937 million in cash equivalents, and marketable debt securities. As we look ahead, we will continue our progress to our breakeven in Therapy Selection, which we are targeting to achieve in the next six to nine months. At the same time, we will continue investing to maximize the large market opportunities in front of us. In order to achieve this balance and fulfill our commitment to capital stewardship, we are leveraging a decade's worth of investments in scaling our core Therapy Selection platform, where we actively manage our growth investments to align with key milestones. We are also gaining material leverage in Therapy Selection, thanks to our rapid volume growth and pay coverage expansion. As our core business in Therapy Selection reaches breakeven, our cash burn will be driven by our two major growth opportunities, MRD and screening. In 2023, MRD spend will continue to be focused on increasing market penetration, our technical platform upgrade, and developing clinical data to support reimbursement coverage. As AmirAli mentioned, for screening, we are managing our spend very closely ahead of FDA approval. We anticipate that the operating loss from our screening pipeline will be less than $200 million over the next 12-month period. With this level of investment, we will be ready for the Shield IVD launch upon successful FDA approval, deliver the next generation of Shield with even better early-stage performance, and make significant progress on indication expansion to lung cancer. Investments beyond this will be contingent on receiving FDA approval and then gated by ongoing commercial success and revenue milestones. Turning to our outlook for the full year 2023 on slide 18. We're raising our full-year 2023 revenue guidance and now expect revenue to be in the range of $535 million-$545 million, representing growth of approximately 19%-21% compared to 2022. This compares to our previous expectation of $525 million-$540 million. This update reflects the very strong performance of our clinical business in the first quarter, healthy market dynamics, and our continued confidence in our competitive strength. Finally, as previously discussed, we expect 2023 operating expenses to be below full year 2022 and free cash flow to improve to be approximately negative $350 million in 2023 and to consistently improve in the following years. Capital stewardship is a top priority for us, and we will deploy cash in line with key triggers such as regulatory approvals, clinical and R&D milestones, and achievement of commercial goals. Finally, turning to slide 19. Our long-term vision is to transform cancer diagnostics through cutting-edge technology, a focus on high-impact opportunities, and consistent execution. At this point, we will now open up the call to questions. Thank you. If you would like to ask a question, then please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure that your phone is unmuted locally. As a reminder, please also limit yourself to one question and one follow-up. Our first question comes from Dan Arias from Stifel. Dan, please go ahead. Good afternoon, guys. Thanks for the questions. Helmy, I wanted to ask about resistance monitoring overall and the Guardant360 Response assay now that you've got the Medicare decision. Can you just talk about the volume contributions and the revenue contributions that we should think about near term, but also maybe a couple of quarters down the road as the assay ramps? As adoption for Guardant360 Response get going, do you see that being impactful to the Guardant360 trajectory? It does seem like there's some off-label Guardant360 usage for treatment response. Just curious if you think that's meaningful going forward. Maybe Mike, is there anything for Guardant360 Response in your revenue guide? Thanks. Yeah, thanks. Thanks for the question. We're very pleased with the recent Medicare approval we got, for Response. It's for the indication of immunotherapy for all solid tumors, which as you know, is I think one of the Really largest use cases in terms of oncology, in terms of major classes, therapeutics where, response can be difficult to assess. This, this is really gonna fill an important need. Response is not a test that we've been pushing very strongly ahead of reimbursement, but now that we have Medicare reimbursement in hand, we're gonna be pushing that a lot more aggressively. I would say that, it's a really a nice sort of key off of an initial Guardant360 test. It's a single test requisition form. There's a certain attachment rate. The two really go hand in hand with one another. This is just the beginning. We'll be increasing and attempting to collect more data. We have publications out there that show this test works and targeted for targeted therapies across multiple tumor types. We'll continue working with payers and certainly with MolDX in terms of trying to expand this further. We'll also be pursuing ADLT status in terms of trying to move up the price as well. I think we have both of those tailwinds and levers ahead of us. I'll let Mike talk about the country. Just on the, on the revenue guides. At the, at the start of the year when we guided, we didn't have anything in for Response. Now we've got the Medicare reimbursement for the remainder of the year. We have to add that to the guidance. It's very sort of very low single digit $ millions. Minimal contribution this year. I think we're really looking at for 2024. Yeah, small amount in the, in this revised guide. Okay. Thanks, guys. Thank you. Our next question comes from Puneet Souda from SVB Securities. Puneet, please go ahead. Yeah, hi. AmirAli, Helmy. Thanks for taking the question. Could you talk a little bit about the next generation Shield for CRC? What do you need to do there? What are the next steps? When could that be potentially submitted to FDA? You know, obviously you have a test that's, at least from a stage II-IV is delivering at 100%, which was good to see. Then stage I, it was 55%. Just maybe talk to us both on stage I and advanced adenoma improvement. Sort of, what's the timeline of improving that and ultimately, you know, bringing this test to market? Thank you. Thanks, thanks, Puneet. You know, we are very pleased actually. We believe this first generation of Shield, the performance that we reported is way above actually what's needed for FDA approval. You know, CMS coverage is clear and also commercial success of this brand. We are gonna take this first generation to the finish line, get the FDA approval for it, and go to market with it. Having said that, at Guardant always we have this philosophy of continuous improvement powered by data. Now this is gonna be another showcase that the first generation of Shield is not gonna be the best and the last of what can be done with blood testing and liquid biopsy. You know, through running ECLIPSE, additional samples that we process, as I mentioned, our team figured out a specific soft class of very early stage cases that, you know, we are missing. The core technology is capable of potentially detecting more of these cases. It's just they were not represented very nicely in our development cohort before. We are pleased, we are excited with the progress we made. Still, it's too early to mention a specific timeline, and we wanna make sure we take this first generation to the finish line. Shortly after, we are gonna operate this device, and we are gonna work with Agency to operate it through potential sPMAs routes to operate the claims. In terms of the routes, I think it's clear, as you know, in terms of upgradeability, we have bunch of additional biobank samples that we have. That was a strategic move that we took at Guardant, that ECLIPSE continued. We have many more CRCs, many more samples in our freezers left over from the first cohort. We just need to process those samples. Let us make more progress and take this first generation to the finish line, then we can talk about the second generation. Got it. One super quick question. Do you expect it to be an annual test with the current first generation? Thank you so much. No, I think when you're looking actually I think it's really like, the biology of CRC when you look at some of the literature in terms of how long it takes for CRC to go from one stage to the next stage based on some modelings, you're gonna see that actually a minority stage I are gonna become like very late-stage advanced IV even three years after. When you're looking into it that really at what intervals you need to run this test, we believe as long as this test is getting done every three years with high compliance, you're gonna detect almost all CRCs at curable age. That's why we are very excited with the potential of this device for CRC. Again, this doesn't mean that this would be the last performance. I would bet you over time it's just gonna continue to get better and better. It cannot get worse. The only way is make it better. Got it. Super. Thanks, guys. Yeah. Thank you. Our next question comes from Jack Meehan from Nephron Research. Jack, please go ahead. Thank you. Good afternoon. My first question is on the Guardant360 ASP, high end of the $2,600-$2,700 range. You know, recently you've had a big acceleration in terms of the covered lives and payer wins. Just curious, as you get better claims experience with some of these new payers, do you think it's possible to outperform that range for the remainder of the year? Can you talk about what guidance assumes in terms of Guardant360 ASP? Jack, it's Mike here. I can take this one. you know, I mean, I think first the main driver of this improved ASP this quarter is really the mix between the CDx and the LDT versions of the test. you know, CDx is from Medicare is reimbursed at $5,000 for the LDT at $3,500. We get a better ASP on the CDx version. you know, some of that mix towards the CDx is being driven by the FDA approvals that we've been getting over the last year or so. I think that can continue positively. Then from the payer, tailwinds, you know, I think as we start to see the claims come through, you know, hopefully we'll see positive momentum there and it could lead to that going higher than $2,700. Our guidance at the moment just assumes that this other $2,700 level. So we'll see. Again, we've had really positive news over the last few months, so that really bodes well for the remainder of the year. Great. Okay. Then sticking with oncology and with Reveal just on guidance, I think previously you were targeting a low double-digit million contribution to sales. Can you talk about how you're tracking relative to that and just how are the volumes building for Reveal? Any updates would be helpful. Thank you. Yeah. Maybe I'll start and I'll let Mike come in. You know, as you know, we've been sort of engineering our overall volume such that we focus on a lot of the reimbursed products and, yeah, that strategy has been working extremely well and so we've seen growth in categories with those products that are best reimbursed. That being said, we continue to see very strong growth in Reveal. I think we mentioned there's over 100% year-over-year. Yeah, I think we're very much on track. Mike, do you have any thoughts? Yeah. No, exactly. We're on track. I think that number we mentioned of low double-digit millions, we're still on track for that, and that's still assumed in the current guide. Thank you. Our next question comes from Kyle Mikson from Canaccord. Kyle, please go ahead. Hey, guys. Thanks for taking the questions. Congrats on the quarter. I want to start on Reveal as well. maybe help me how sticky has Reveal been with clinicians invasion? Are you seeing a shift in more tests performed in that recurrence monitoring setting where you don't have a rate right now? Also if you could comment on timing of private or commercial payers, and the other reimbursement for Medicare as well, that'd be helpful. Thanks. Yeah. We're seeing, I think, very similar mix to what we've been seeing. We've been focusing a lot more on reimbursed volumes, so it's the CRC indication and the adjuvant setting. If anything, we've seen utilization in the kind of the sort of the existing indications, you know, continue to be strong. You know, we're making excellent progress in terms of additional clinical data sets. We're hopeful that we'll still be on track to have some of those released later in the year. Once those gets published, you know, assuming they're positive, we'll submit that for breast cancer and for the additional surveillance setting in CRC. Okay. That's perfect. Thanks for that. Then AmirAli just one on the kind of ECLIPSE data from earlier this morning. Thanks for doing that call, guys. In the DDW data on stage I sensitivity included those five incompletely staged CRCs. If those were more advanced, those could move stage I, I guess you would have picked up more cancers. I know you're being conservative here, but would FDA and USPSTF take that kind of a nuance into account? If you back those out, overall stage I sensitivity would be much higher. I'm just curious how they would sort of treat that aspect. Let me just say a few words and I ask Craig to provide more details. Those malignant polyps are malignant. They are CRCs, but they are like so early stage looks like that, you know, even the patients are not going through the next step in terms of staging and the doctor thinks they've done all the treatment required. I'll let Craig to provide additional details. Thanks, AmirAli. It's Craig. One of the things to think through and when you get to assessing the data, it's about everyone's gonna have a different perspective on these cases. What we're providing is, to the FDA and others, is a transparency around how they were staged and then how the malignant polyps were managed and not staged if you use traditional criteria, AJCC or the more histological basis. How are they gonna deal with that? That's something obviously we're gonna work with them on and talk to them about, and we'll just have to see how that spans out. It's quite clear that, you know, there's differences in the way they were staged, differences in the protocol, and these are things FDA no doubt will wanna talk about. Got it. Okay. Thanks, Craig. Thanks, guys. Thank you. Our next question comes from Julia Qin from JP Morgan. Julia, please go ahead. Hi, good afternoon. AmirAli regarding the under $200 million spend on Shield over the next 12 months, could you give us a sense of, you know, what's the rough split between commercial and R&D, including line extension and then the next generation test development? Does that include a potential step-up investment once you receive FDA approval, which I assume is within the next 12-month window? How would you characterize the sufficiency in commercial investment in this $200 million budget, especially given that we know sales and marketing plays a pretty important role in driving adoption? Thanks. Yeah. Thank you. We believe with this level of investment, actually it's, you know, we are adequately resourced to really have a successful IVD launch that definitely includes the sales and marketing resources to launch this product. It's not that right after we are gonna increase our spend significantly on the S&M side. Actually, it's all embedded in that number. It's gonna be around that till we make more progress, actually, that some of our R&D kind of activities would kind of taper down in terms of some of the studies would end and so forth. In terms of the split of that $200 million, you know, still, we are kind of heavy on the R&D side, just based on the trials that we are doing, some of the technology improvements that I talked about, and some of the infrastructure that we are building to be able to really be able to handle the samples at scale with low cost and so forth. Still it's really R&D heavy. There are reasonable amounts of actually sales and marketing, very reasonable amount that, you know, we believe is adequate enough to have a successful FDA launch for this product. As we make actually more revenues and we meet the milestones on increasing the ASP and getting the revenue coming with kind of the volumes that we expect, we are gonna manage our operating expense. Keep in mind, as I mentioned in the prior calls, we believe you can have much higher efficiency running the S&M for a blood-based screening test, especially for us that we would be first mover in a completely new category. Frankly, in this new category, it's not that we are competing with other players based on what we are seeing in LDT. We are gonna have that first-mover advantage in terms of market penetration, and already we shaped the market a little bit based on the accounts that we are in, that we feel confident actually post FDA approval, we are gonna have a successful launch with this level of investment that I mentioned earlier. Thank you. Our next question comes from Dave Delah unt from Goldman Sachs. Dave, please go ahead. Hey, guys. Thanks for the additional color on the data earlier today. Julia actually took part of my question on the sales and marketing. If you guys could give us a little bit more color on the sales force ramp and the strategy for calling on all the PCPs across the country. If you're thinking about any other types of media campaigns or anything to get in touch with these PCPs and get Shield out there and get its patients. Again, actually, at the time of FDA approval and shortly after that, for a few quarters after even FDA approval, we are not expecting that we are gonna have a very large sales force in terms of what we need to have for national coverage. You know, at the end, like as we are getting to USPSTF timelines in our commercial team, as I talked about before, potentially it's gonna be about 700, 800 people. At the time of FDA launch and in a few quarters after that, it's gonna be a tiny fraction of the number that I mentioned. We believe in our strategy based on actually what we are seeing in the market right now and the depth of ordering that we are seeing for the blood-based cancer screening. When you look at the depth of ordering, when you look at actually higher efficiency selling, that's because of patient adherence. More than 90% of sold tests would get converted to billable case versus for other modalities, it's a very leaky process, frankly. This gives us confidence that in order to meet the revenue milestones that we have in mind, we don't need to go to hundreds and hundreds of people in the commercial team. We can really do it very efficiently, and we will execute, and we will show that this is possible. Definitely in terms of our OpEx, it's not that we get FDA approval, and we are gonna ramp it up significantly. We are going to meet some revenue milestones and step-by-step milestone driven, we would increase our investment justified by the revenues that we are seeing, and we will manage our contributing operating loss accordingly, very close to the number I mentioned earlier. Great. Thank you. Thank you. Our next question comes from Mark Massaro from BTIG. Mark, please go ahead. Hey, guys. Thanks for taking the questions and congrats on the strong quarter. My first question is for you, Helmy. When we think about the portfolio of therapy selection, you know, obviously you guys are the strong market leader in blood. As you're gaining additional traction with Guardant360 Response and Guardant360 TissueNext, Guardant360, and then Guardant Reveal, you know, to what extent do you think you can start moving perhaps some other competitive assays onto the platform by through bundling? I wanted to get a sense if you have a ballpark of what the attachment rate is between Guardant360 and some of the other tests. We, you know, have this essentially, you know, ecosystem of tests now where we can really manage the complete interaction from a precision oncology point of view that an oncologist has with their patients. And a lot of this will fall into place further as we move to the smart liquid biopsy platform, where it'll really make the sort of data connections between the different pieces much more powerful and increase the utility. We're already seeing that right now. We're going through this evolution, we call this Guardant Complete, where essentially a physician can push one button and really get a sort of testing workflow that they request in place for their patients. If they want to start with liquid and reflex tissue, if they want a response test after the patient's put on immunotherapy, all of that can be managed seamlessly now. We're really turning a lot of those features on. I don't think we've broken out the attachment rates, but we've seen, you know, very strong, I would say, connectivity between our tissue tests and our blood tests in terms of the initial Guardant360 tests, as well as response tests. It's working. It's why, you know, I think one of the strongest leverage points we have is the fact that our Guardant360 business itself, which is that first test, is growing very, very rapidly. We're actually, we believe, taking market share, not just growing, but taking market share from other companies. Everything else is a function that gets attached or connected to that initial time point. We're feeling very good, going forward and, it's an exciting time for us. Great. Maybe one for AmirAli. You know, obviously the stage I through III sensitivity at 81% certainly exceeds the FIT test. I wanted to get a sense, obviously stages II through IV were excellent at 100%. To what extent should we look at the 55% and just wonder what the uptake of the test will be in light of, you know, the incredible sensitivity at stage II where it is surgically resectable? Just give us a sense for how to think about the numbers overall. I maybe make a few points about this. Number one, bear in mind we are talking about a new market category here for the people who are delaying or refusing to get any kind of screening done at this time. For those patient population who are not participating in any modality of screening, I think we need to have a right perspective in terms of like, they are not getting FIT done, they are not getting other stool tests done, they are not getting colonoscopy done. The most important thing, and actually what we heard also in the call that we coordinated with experts, opinion leaders in the field, is the most important factor is making sure the uptake of the test is proper and patient participation is adequate. Blood test has that kind of advantage. That's why I don't think necessarily like kind of comparative numbers is the most important factor here in terms of adoption. Number two, in terms of what data, which data should we look at? I look at what level we are gonna get FDA approval, we are gonna get Medicare coverage, we are gonna generate access for all patients who are eligible for this test. Those numbers are clear. We know it, you know it. Like, you know, our test performance is what we've reported is way over those minimum requirements. When we go to early stage, I think we have to keep in mind when you cut the data into smaller pieces, like there are some statistical variation associated with it just from scientific mentality. If you just look at these numbers in face value, it's exciting to see you're detecting all cancers at stage II, at stage III, and let's say half of stage I. for the patients who are not getting screened and they don't have any symptom, what fraction of the missed stage Is are gonna become stage IV, three years after? When you look at it's a minority. In a longitudinal test, for a test that patient adhere to, which is not applicable to other modalities, this kind of test performance on its face value is kind of exciting, and that's why we believe it would detect nearly all CRCs at curable stage and would save many lives. Excellent. Thank you. Thank you. Our next question comes from Derik De Bruin from Bank of America. Derik, please go ahead. Good afternoon. This is John on for Derik. Last quarter in biopharma, you guys were seeing some headwinds with some clients delaying their decisions. Has there been any improvement? Obviously, you spoke of your strong order book, so I was wondering how that's balancing out with your order book. In terms of Japan, how are the conversations going in terms of getting that reimbursement finally? No, you know, I think when we mentioned that on the biopharma side, I think there are, you know, potential for some headwinds. You know, we hadn't necessarily seen them affect, you know, our business considerably. You know, we're obviously doing, you know, extremely well in terms of biopharma volume. We're happy where things are. We're happy with what the pipeline looks like. We do think that, you know, as we said, that some of that will resolve, you know, some of that uncertainty around budgets and so on will resolve second half of this year. We're seeing a lot of very encouraging conversations we're having with, you know, pharma companies across multiple programs. We think this is gonna continue to be an important growth driver for our business. In terms of Japan, we're having good conversations there. Yeah, we still think we're on track for this year to have a reimbursement there, and that'll be a big business for us. I'll just add, you know, I think we're making good progress in China as well, and we think that'll also be a similarly strong business for us once that gets going. Thank you. Thank you. Our final question comes from Tejas Savant from Morgan Stanley. Tejas, please go ahead. Hey, guys. Good evening, thanks for the time here. One for you, Helmy, on the Guardant response testing protocol. Can you just lay out in your mind, like what do you think are the advantages of measuring just those two time points over the course of IO treatment versus tracking the patient over a longer period of time via multiple follow-up tests? I mean, for example, if a physician wants to, you know, look at that continue/discontinue decision a little bit later, how would that work? Is it relatively rare to use an assay in that fashion right now? Yeah. I mean, you look at the literature, including, you know, other tests that are out there. A lot of the clinical utility, almost all of it really derives from the initial time point post treatment initiation. That's really the benefit. If you wait out longer, then you're, you know, essentially you can start relying on other approaches, radiographic imaging and so on. It's, you know, we don't think that, you know, you're missing out, by using kind of that time point, and it's really focusing on what the data shows and, you know, where the clinical utility is. That doesn't mean that there may, you know, be use cases in the future where, monitoring may be beneficial. Obviously, that's where the field is going, is extensive monitoring. We don't see much, sort of, you know, almost any loss in sort of utility or value by. In fact, it's, you know, it's nicer if we just, you know that with a single test, you can help make a decision. Got it. That's helpful. Then one quick one for AmirAli here. You know, AmirAli, with ECLIPSE sort of full staging sort of now available, how does the CRC mix by stage compare with your, you know, previous, you know, a priori expectations, if you will? You know, we had a few inbounds on more stage IV patients in ECLIPSE versus, you know, DeeP- C, et cetera. Were there any differences in trial design in retrospect that may have contributed to the differences in the mix for the population enrolled? Maybe I make a few statements, and then I ask Craig to chime in here. You know, in fact, when you look at the public databases on, like, the staging distribution of recently diagnosed CRC patients, it's actually pretty close. Like, I think if I recall right stage IV, it's about 20% of the patients are getting diagnosed stage IV. in 65 patients in this cohort, we had 10. It's kind of pretty close. Craig, do you wanna add? Yeah. On that note, I mean, you know, we're talking about small numbers when you compare across trials, number one. Also, time difference for those trials you talked about. Our study collected a diverse U.S. population, so it's really at that point in time. You know, you can start to get into theories about what's the difference between a population from 2019- 2022 versus 2012- 2014. Obviously, one thing that would make a nice story is COVID, and people talk about the delay in screening and other things. As AmirAli mentions, when you look at the stage IV breakdown, it's actually pretty much spot on to where things would expect from other databases in the population. Got it. That's helpful. Thanks, guys. Appreciate the time.