Hello everyone, and welcome to the Guardant Health second quarter 2023 earnings call. My name is Emily, and I'll be coordinating your call today. After the presentation, there will be the opportunity for any questions, which you can ask by pressing star, followed by the one on your telephone keypads. I'll now turn the call over to investor relations. Please go ahead. Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30th, 2023. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO, AmirAli Talasaz, Co-CEO, and Mike Bell, Chief Financial Officer. 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 reconciliation to 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. The 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, Carrie. Good afternoon, thank you for joining our second quarter 2023 earnings call. I will start off our call today with our top-line results for the second quarter and go into more detail on our progress in therapy selection and MRD. I will turn the call over to Amir Ali for an update on screening. Finally, Mike will provide a more detailed look at our financials and outlook for the remainder of 2023. Starting on Slide 3, at Guardant, we are singularly focused on our mission to help patients across all stages of cancer live longer and healthier lives with the data provided from our powerful blood tests. In line with this priority, we will start our call off by sharing a patient story. In September 2021, a 56-year-old woman had a colonoscopy that revealed colon cancer. She had curative intent surgery, which removed 32 lymph nodes. Pathology indicated a diagnosis of stage two colorectal cancer with no evidence of disease in the removed lymph nodes, as well as negative margins on the resection. With this information, her oncologist determined there was a low risk of recurrence and chose not to administer adjuvant chemotherapy. At a checkup three months post-surgery, a CEA test was drawn and showed normal results. At her next three-month check-in, her CEA doubled but was still within normal limits. The patient requested that her oncologist order a Guardant Reveal test. The results were positive for ctDNA, and as a result, her oncologist put her back on chemotherapy. Since then, she has had two consecutive follow-up Reveal tests, showing her to be ctDNA negative, and today, she is fortunately showing no evidence of disease. This story highlights the power of our tests to provide meaningful decision support to oncologists and patients earlier in the cancer journey in the MRD setting. Guardant is the liquid biopsy industry leader in therapy selection, giving us a strong foundation in cancer patient care. From this foundation, we are building out our pipeline of multi-billion dollar opportunities in MRD and screening, which we believe will lead to a step change in the magnitude of impact we can have on patients' lives. Turning to top-line performance on Slide 4, we had another very strong quarter, with revenue growing 26% to $137.2 million. This robust growth was driven by precision oncology revenue, which increased 36% in the quarter. I am really pleased by the great progress that we continue to make in our therapy selection business that illustrates we are still in the early innings of this uptake, with much more growth ahead. Turning to Slide 5. Indeed, our team delivered strong growth across precision oncology, surpassing 50,000 combined tests during the quarter. Clinical test volume during the second quarter reached 43,500 tests, an increase of 49% from the prior year quarter. Clinical growth was driven by strong contributions from our key products, supported by a robust commercial platform. For biopharma, we delivered 6,700 tests, increasing 12% year-over-year. Turning to Slide 6. Looking more closely at the growth drivers for our therapy selection clinical volume, we continued to benefit from the tailwinds we saw at the beginning of the year with strong growth in lung, with continued strength of our high performance and rapid turnaround Guardant360 tests. In breast, fueled by a recent Guardant360 CDx approval for ESR1 mutation-positive patients, and in tissue, aided by our AI-powered Galaxy Suite. As a reminder, we introduced the Guardant Galaxy Suite of advanced AI analytics for digital pathology applications in partnership with Lunit to enhance our portfolio of cancer tests, starting with the TissueNext PDL1 test, shown to improve biomarker detection by more than 20% in non-small cell lung cancer. For MRD, Reveal continued to do well, and we again saw strong volume growth of greater than 100% year-over-year. We are also making excellent progress in our clinical data pipeline for Reveal and look forward to sharing more about this at our upcoming Investor Day. Our team has worked incredibly hard to establish Guardant as the leader in liquid biopsy. We have made critical investments into our commercial infrastructure that are now paying dividends. We lead the market in share of voice and overall satisfaction with customer experience. To that end, we have finished development and begun integration with the top three oncology EMR providers in the United States. These providers collectively cover nearly two-thirds of all oncology practices in the country. As expected, we see strong increases in ordering volumes once a particular account is able to order our tests through their EMR system. As we continue to broaden our customer base, we look forward to driving further increases in volumes across our product portfolio within such accounts. Moving on to Slide 7. We had some big breakthroughs in payer coverage during the past quarter that will provide tailwinds for our clinical business in the near term. Since our last earnings call, we secured coverage from Anthem, Blue Cross Blue Shield, Aetna, and Humana for our Guardant360 test. These tests are now covered for comprehensive genomic profiling by all major U.S. commercial health insurers, with over $300 million covered lives. We are also making good progress on increasing covered lives for newer products in our portfolio. For example, with TissueNext, we are approaching $200 million covered lives and hope to cross this threshold later this year. We also recently received our first commercial coverage for Guardant Reveal. Blue Cross and Blue Shield of Louisiana is providing coverage for Guardant Reveal for individuals with Stage II or Stage III colorectal cancer after curative treatment, including surgery. This is a major milestone for patients. This is the first time a liquid-only MRD test has been granted reimbursement coverage by a private payer to inform physician decisions about post-treatment therapy and to monitor for disease progression, recurrence, or relapse. Importantly, this coverage provides broad access for CRC patients at stage two or three, which amounts to a significant number of tests for patients across the adjuvant and surveillance settings, in line with NCCN monitoring guidelines. On to Slide 8. Outside of the United States, we are continuing to make progress on our strategy of achieving global scale with a focus on large core markets. Most notably, we recently received national reimbursement approval from the Japanese Ministry of Health, Labour, and Welfare for Guardant360 CDx, which became effective at the end of July. Japan currently represents the largest expansion opportunity for our portfolio of products outside of the United States. There are more than 390,000 deaths from cancer each year in Japan and more than 1 million new cancer cases annually. Despite this large population, CGP testing is still in its very early innings of adoption, with currently about 25,000 CGP tests performed annually and only 15%-20% of that in blood-based testing. In addition, Japan has focused centralized care with about 260 core genomic hospitals. Importantly, Japan is a single-payer healthcare system, and we receive pricing that is in line with our U.S. ASP of $2,600-$2,700. With this pricing, we expect our clinical testing for Japan to have positive margins and contribute to our therapy selection business, reaching breakeven by the end of the year. This reimbursement decision represents a significant milestone for our international business. We are encouraged by the strong support we have received from oncologists in Japan, we look forward to furthering these partnerships as we continue our commitment to democratize access to precision oncology and bring blood-based comprehensive genomic profiling to patients and care teams across the region. Beyond Japan, we are also very excited about our opportunities in the U.K. and China, we look forward to providing updates on our progress across our international business in the future. With that, I will now turn the call over to AmirAli to provide an update on our screening business. Thanks, Helmy. Turning to Slide 9. We are continuing to make advancements in our screening business as we spearhead a new patient-preferred category in the screening market with our Shield blood test. We are making steady progress with the FDA review of our PMA package for Shield, and we are pleased with the recent successful pre-approval inspection by the agency. We continue to expect FDA approval and the launch of Shield IVD in 2024. Turning to Slide 10. We continue to believe that Shield will transform CRC screening and result in more lives saved. We have developed and validated a discrete event simulation model, integrating real-world longitudinal adherence rates to evaluate the effectiveness of Shield relative to existing screening modalities. At a conference in late June, we presented the initial results from our health outcome modeling. This model examined a simulation of average-risk U.S. adults receiving a Shield screening test every three years. On the left, we see the health outcomes over a lifetime horizon when assuming real-world adherence to different screening modalities. Life years gained for Shield was 217, with 820 total colonoscopies, while the life years gained for other modalities was in the range of 126 to 255, with 126 to 1,996 total colonoscopies. This initial data shows for Shield the life years gained versus the number of colonoscopy is in range, even favorable, compared with other guideline-recommended tests. At Guardant, it is in our DNA to stay at the forefront of innovation. With Guardant360, we launched the best-in-class liquid biopsy and have maintained our market leadership with continued performance enhancements. We are taking the same approach with Shield. We are confident that the performance of current version of Shield exceeds the bar for approval, guideline inclusion, and reimbursement. This is just the beginning for what Shield can offer. Since we filed our PMA with the FDA, we have made progress developing a more sensitive next-generation Shield, powered by data and clinical insights gathered from early-stage CRCs, including Stage 1 malignant polyps. We look forward to sharing more later this year. Moving on to Slide 11. At Guardant, we have always had a vision for blood-based multi-cancer screening. We started with CRC as the first indication for Shield because of the established pathways for FDA approval and reimbursement, which allow for broad access. We are planning to add lung cancer as the second indication. Lung is the leading cause of cancer-related mortality. There are about 15 million high-risk individuals eligible for lung cancer screening. However, the overall screening rate is less than 15% due to the complexity of guideline-recommended screening modality and significant follow-up requirements. This is where the value of our differentiated blood-based test comes into play. We are pleased with our progress in our NCIRE study. We are also making good progress on recruitment for our pivotal SHIELD LUNG study and have surpassed 6,000 patients enrolled. Beyond lung, we plan to add a large panel of cancers all to the same test. As a reminder, we are committed to non-operating loss from our screening pipeline of less than $200 million for the next 12 months. This will fund our top priorities in screening and set us up to achieve our upcoming milestones. With that, I will now turn the call over to Mike for more detail on our financials. Thanks, AmirAli. Turning to Slide 12 to review our financial results. Total revenue for the second quarter of 2023 grew 26% to $137.2 million, compared to $109.1 million in the prior year quarter. Total precision oncology testing revenue for the second quarter was $125.2 million, increasing 36% compared to $92.1 million in the prior year quarter. As in previous quarters, this increase was driven by strong year-over-year growth in clinical and biopharma volumes. Precision oncology revenue from clinical tests in the second quarter totaled $100.2 million, up 42% from $70.5 million for the prior year quarter. Second quarter clinical test volume was 43,500, an increase of 49% from the same period of the prior year, and an increase of 11% or 4,400 tests from Q1, 2023. While Guardant360 continues to be the main revenue driver, with continued strong growth in lung cancer and a significant uptick in breast cancer, we again saw a very strong year-over-year volume growth in both Reveal and TissueNext, both growing over 100%. Second quarter Guardant360 ASP continues to be at the upper end of our target range of $2,600-$2,700. As Helmy mentioned, we had some big breakthroughs in paid coverage during the past quarter. While this additional coverage will provide tailwinds for our clinical business in the near term, we expect, however, that it will take some time for these upsides to flow through to our clinical ASP due to the length of time it takes to contract with insurers. Blended clinical ASP was approximately $2,300, in line with our expectations. 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 second quarter totaled $25.0 million, up 16% from $21.6 million for the prior year quarter. Biopharma test volume was strong, with second quarter totaling approximately 6,700 tests, up 12% from the prior year quarter. Biopharma ASP in the second quarter was approximately $3,700, which was higher than both last quarter, at $3,550, and the prior quarter, at $3,600, due to the product mix. Development services and other revenue for the second quarter totaled $11.9 million, down $5.2 million, or 30% from the prior quarter. This was primarily due to the timing and amount of milestones related to our partnership agreements and the change in companion diagnostic collaboration projects with biopharma customers. Gross profit for the second quarter of 2023 was $83.3 million, compared to a gross profit of $72.4 million in the same period of the prior year. Gross margin was 61%, compared to 66% in the prior year quarter. The change in gross margin was driven by a number of factors. For precision oncology, gross margin was 61% in the second quarter of 2023, compared to 63% in Q2 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 $2,400-$2,300, due to the increased proportion of clinical volume coming from Reveal TissueNext in Response. Development services and other gross margin, 62% in the second quarter of 2023, compared to 86% in Q2 2022. The change in margin was primarily due to the cost of processing Shield LDT samples as part of our market development activities, for which we are currently booking minimal revenue. We continue to expect overall gross margins to be approximately 60% for the full year 2023. Operating expenses for the second quarter of 2023 were $202.9 million, compared to $202.7 million in Q2 2022. Net loss was $72.8 million, or $0.67 per share for the second quarter of 2023, compared to $229.4 million, or $2.25 per share in the second quarter of 2022. The year-over-year reduction in net loss is primarily due to three factors. Firstly, our loss from operations reduced from $130.3 million in Q2 2022 to $119.6 million in Q2 2023. Secondly, in Q2 2022, we booked another expense of approximately $100 million to reflect the increase in the fair value of the outstanding shares in our EMEA joint venture, which we acquired in June 2022. Finally, in the second quarter of 2023, we recorded a $64 million unrealized gain related to our strategic equity investment in Lunit, our AI partner for TissueNext, which had its IPO in Korea last year and has seen a substantial increase in its share price over the last few months. Moving on to non-GAAP financial measures on Slide 13. Non-GAAP operating expenses were $180.5 million for the second quarter of 2023, a 2% increase from $176.2 million in the prior year quarter. Non-GAAP net loss was $88.7 million or $0.82 per share for the 2Q 2023, compared to $101.8 million or $1.00 per share for the 2Q 2022. Adjusted EBITDA was a loss of $85.2 million in the 2Q 2023, compared to $94.3 million loss in the 2Q 2022. Free cash flow for the 2Q 2023 was negative $100.5 million, compared to negative $135.0 million in Q2 2022. We continue to make very good progress in diligently managing our operating expenses and cash burn, and we are confident that we will achieve our stated goal of lowering our full-year operating expenses compared to 2022, as well as reducing our free cash flow to approximately -$350 million for the full year. Turning to Slide 14. In May, we completed a successful equity offering where we raised $381 million in net proceeds. This puts us in a very strong position with approximately $1.2 billion of cash, which provides the runway to reach cash flow breakeven, which we are targeting in 2027, 2028, one to two years following Shield inclusion in CRC screening guidelines. As we look ahead, we are still on track to achieve cash flow breakeven in therapy selection within the next three to six months. We'll be able to achieve this milestone as we are now gaining significant leverage from the investments we've made over the last few years to scale our core therapy selection business across commercial, lab, and back office operations. As we've been able to maintain high volume growth and consistently strong ASPs and gross margins for Guardant360. MRD spend will continue to be focused on increasing our market penetration, our technical platform upgrade, and developing clinical data to support reimbursement coverage. However, we are confident that the total investment in MRD across the next five years can be sorted from the total contribution generated from therapy selection and from increasing Reveal revenue, driven by reimbursement coverage. For screening, we anticipate that the operating loss from our screening pipeline will be approximately $200 million per year over the next five years. Over the next 12 months, we were ready for the Shield IVD launch upon successful FDA approval, deliver the next generation of Shield with potentially even better early-stage performance, and make significant progress on indication expansion to lung and other cancers. Investments beyond this will be contingent upon receiving FDA approval and then gated by ongoing commercial success and revenue milestones. Now, turning to our outlook for the full year 2023 on Slide 15. We are raising our full year 2023 revenue guidance and now expect revenue to be in the range of $545 million-$550 million, representing growth of approximately 21%-22% compared to 2022. This compares to our previous expectation of $535 million-$545 million. This update reflects the very strong performance of our clinical business in the second quarter. For the remainder of the year, we expect to see a sequential decline in development services and other revenue in Q3 due to the timing of project milestones and declining royalty revenue. For the fourth quarter, we expect to see a seasonal uptick in biopharma volume that we've historically seen towards the end of each year. ... Finally, as just mentioned, we continue to 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. Turning to Slide 16. Our long-term vision is to transform cancer diagnostics through cutting-edge technology, a focus on high-impact opportunities, and consistent execution. In the second quarter, we were very pleased to achieve major reimbursement milestones, obtaining national reimbursement coverage for Guardant360 in Japan, and our first U.S. commercial reimbursement coverage for Guardant Reveal. Finally, turning to Slide 17. We'll be hosting our first Investor Day on Thursday, September the 7th in New York City. We look forward to sharing a deeper dive across our business. Please reach out to investors@guardanthealth.com for more information. At this point, we'll now open the call up to questions. Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please do so now by pressing star, followed by number one on your telephone keypads. If you change your mind and would like to be removed from the queue, that is star followed by two. We ask that when preparing to ask your question, you please ensure that your device is unmuted locally. The first question today comes from the line of Jack Meehan with Nephron Research. Jack, please go ahead. Your line is now open. Thank you. Good afternoon. wanted to ask about, the clinical volume really showed strong momentum this quarter. Is it possible to call out where you're seeing high cancer indications like, breast cancer with the CDx approval versus lung or others? Yeah, that's a great question, Jack. Yeah, we're seeing, I think, really strong growth across multiple indications, and I would say that it's both lung and breast that are carrying the momentum we started from the beginning of the year. I think we're just seeing further consolidation behind our product, given the leading turnaround time and leading performance we have with lung. It just really does have the product market good. We see that we're probably testing more lung cancer patients in the United States, in the metastatic setting with NGS than really any other modality, tissue, or liquid. It's really a great place to be, and I think we're just seeing continued momentum there. Obviously, with the breast, with the ESR1 drug approval, we're continuing to see a nice volume lift. Breast has really taken, a, swing up, in terms of volumes. We're doing very large percentage of metastatic breast cancer patients now in the, in the United States, and so we've really been pleased by the progress we've made, there. The growth is just not limited, to, to those two indications. We're seeing it across the board. Great. Follow up for Mike. On the clinical ASP, I know you said the Guardant360 toward the top end, $2,600-$2,700. I was wondering if there were... You know, we've heard one other lab that reported tonight talk about some claims issues with some Blues plans. Heard others talk about payment integrity. I was wondering if maybe you're seeing incremental traction with some of the new coverage, but were there any headwinds that are keeping it within the range versus above the top end? Thank you. Yeah, Jack. No, there's, there's no headwinds that we're seeing with, with, with payers, we're not seeing any sort of negative traction with any, any payers. I think, you know, yeah, we've definitely had tailwinds with respect to future ASPs. You know, we've, we've gained coverage now from these major payers in the last, in the last three months. I think, yeah, we've been at pains to sort of point out that even though we've got the coverage, it's just gonna take time to see that coverage come through to, to ASPs. 'Cause, you know, we need to go through the contracting phase, and then we need to start to see the sort of new rates come through from those, from those payers. You know, we're confident that over time, our ASPs will continue to track upwards and potentially beyond that range that we're currently in. Yeah, it'll just take time. We've not seen it now, and maybe just to add, you know, for the remainder of the year, we're still sort of forecasting within this $2,600-$2,700 range. If things were to happen quicker than expected on the contracting side with the payers, we could have some upside there. Yeah, so far, things are steady. Our next question comes from the line of Puneet Souda with Leerink Partners. Puneet, please go ahead. Your line is open. Great. Helmy Eltoukhy, AmirAli Talasaz, Mike Bell, thanks for taking the question. First one on a Guardant Reveal. Wondering if you can provide any context around, you know, contribution in the quarter. What are you expecting for within the guide for the full year? Are there any updates on, you know, upgrade of the assay? Because obviously, the upgrade of the assay then drives the submission to the common MRD LCD that is out there. Maybe just, you know, if you could outline the sort of the timeline on that, and then I have a follow-up on FDA for AmirAli Talasaz. Take the first part, and then I'll take the second. Yeah. You know, we're, I think the color on Reveal, and, you know, we're not breaking out those volumes. Certainly not done that. You know, I think we said in the prepared remarks, in the quarter, Reveal volume grew over 100%. So we're really pleased with the continued traction that we're getting there. I think previously, we've talked about Reveal revenue being sort of low double-digit millions. Yeah, we're still on track for that. Yeah, overall, Reveal's going really well, and as well as we would hoped. That's probably as much color as we're giving in the numbers, Helmy? Yeah, no, I mean, I think the Smart Liquid Biopsy transition, you know, is sort of on track and will continue to happen this year. Obviously, we've been really digging in in terms of the capabilities of this new platform, and it's just frankly, you know, amazing us every single day in terms of the increased capabilities that we can have. Just I think it's, you know, not only gonna make the performance of our tests, so much better in terms of sensitivity, specificity, what we can do with it. But just the capabilities that'll offer the field are frankly groundbreaking, not just in the field of oncology, but even to our understanding of the science of disease progression. So, yeah, we're very, I think, hopeful that we can present some of that data at our Investor Day as well. Yes, it's, it's going better than we planned. Thanks. Look forward to that. Just on FDA for AmirAli. Wondering, you know, if you could provide us an update if the Shield 2.0, or the next generation improvements that you're doing in the assay, is there a way to submit that as a supplement into the current FDA filing? Also wondering, you know, do you think FDA is going to put weight on the adherence, you know, aspect of this assay? Just wondering, your thoughts on those two points. Thank you. Yeah. Thank you, Puneet. As I mentioned, we are making steady progress with the agency. In terms of V2, we are also excited with some actually insight that we are getting on V2. We see actually what happens in terms of the regulatory pathway for V2, you know, our current assumption right now, our best judgment is, you know, hopefully, we get V1 approved. Due to the fact that the V2 is just optimized algorithm on the same chemistry, all the workflows are the same, effectively, it would be just supplemental PMA review by the agency that we are planning to submit right after we get approval for our first version. That's our operating assumption at this time. In terms of adherence, already the agency actually acknowledged in multiple occasion for us that they acknowledge the value of blood-based testing for this field. We believe actually it's on the top of their mind, that blood has some kind of unique value for this field and based on the experience that they have. We'll see. Our next question comes from Tejas Sawant with Morgan Stanley. Tejas, please go ahead. Your line is open. Hello, this is Yuko on for Tejas. Thank you for taking our question. I was wondering when can we see the next gen Shield validation data, and could that come as soon as year-end? If so, what venue should we be looking out for? Yes. Actually, we are expecting to share actually more information on this actually later this year. Please stay tuned. Great. I also have a follow-up. Generation of outcome data will take time, but when should we expect the next larger cohort data on a tumor-naive approach? Then separately, how do you go about getting mind share from physicians who are already using a tumor-informed approach? Can you give us a sense of what proportion of current customer accounts are using competing MRD assays versus just the tumor-naive approach? Yes, it's a great question. Yeah, we've made really great progress in terms of clinical validation cohorts. Others who have clinical utility studies have been running for some time. You know, we're gonna present, likely more data later this year in breast and colorectal cancers. I think that data, you know, hopefully, if it's positive, will look, you know, get published sometime next year and will allow us to expand reimbursement. Yeah, we're very confident that, in terms of the performance of this, this platform can do much better than almost, you know, any sort of tissue-informed approaches because of the science and the sort of ability to detect more features for a test. We're, we're pleased. We're looking forward to presenting more of the background around the technology, how it works, and why it works, and some of the data at our Investor Day. Yeah, we're seeing great traction. I mean, when you have a test that is much faster, doesn't require tissue, there's product-market fit that's undeniable. We saw this with tissue biopsies and liquid biopsies with Guardant360 and lung cancer. People asked us, you know, "Why would, you know, someone use a blood test instead of a tissue biopsy? You know, tissue biopsy is the gold standard. There are way more patients in the U.S. getting NGS from Guardant360 liquid biopsy than tissue biopsy tests today. Once you have product market fit, that becomes the gold standard and the North Star, by which everyone will have to follow. It's, yeah, we know we're on the right path. It'll take, you know, some time to get there and to ramp things up. It's, you know, we're, we're very pleased with the progress so far. Our next question comes from Dan Brennan with Cowen. Dan, please go ahead. Your line is open. Hey, it's John for Dan. I believe the previous guidance range is based on clinical volume growth of about 35% year-over-year. With, 1H tracking well ahead here, is there an updated number you're looking for for the year? Sorry, is there an updated what? What, what was the question again? Clinical volume growth number, because I think the last, the last, guidance was based on 35% year-over-year. You're tracking pretty far ahead of that in 1 H. Yeah, I think, yeah, clinical volume's obviously, obviously growing, growing very strongly. You know, 49% in this quarter was, I'd say, ahead of our expectations. I think as, as we look out for the, for the guidance, and the increase that we've seen, the increase that we've just had in our, in our guidance, it's all driven on the, on the clinical volume side. I would, I would say, now our expectation is probably trending to the, you know, high 30s, low 40% growth on the clinical volume. We're, we're able to have an, have an increase from the previous 35%. Got it. Then back on ASP, I get it'll take some time for the coverage rates to flow through your pricing, but is there some range that you see blended clinical ASP going when the, the rates are locked in and the increases are fully realized? Yeah, you know, I mean, it's easier to talk about the, the Guardant360 ASP. I think, you know, yeah, today it's at the higher, higher end of that $2,600-$2,700 range. I think, you know, if we get sort of full coverage from all of these major payers and we can, we can contract with those payers, then, you know, over time, we think the ASP can get north of $3,000. You know, potentially a significant increase. It is gonna, it is gonna take time. It's, it's harder on the blended ASP. It's primarily, you know, obviously, it's due to, it's due to the mix, and the mix between Guardant Reveal, Tissue, and Guardant Response. So how that mix changes over time, you know, it's, it's, it's very difficult to sort of forecast. Then, as each of those products get incremental reimbursement over time, and we've got pathways for each of that to happen, then, you know, I think overall for each product, those ASPs are gonna increase. To be able to really forecast, say, beyond the end of this year, what that blended ASP is gonna look is very difficult. I'd say, our assumption for the remainder of this year is that the blended ASP is gonna stay around this sort of $2,300 level. Our next question comes from Derik De Bruin with Bank of America. Derik, please go ahead. Your line is open. Hi, good afternoon. This is John on for Derik. Appreciate the color on the, the market landscape in Japan and, the pricing and whatnot. I wanted to ask what you see to be the the contribution from that market over the next couple of years. If you could talk about the ramp, that'd be great. Yes, it's Mike. I can, I can take that. Yeah, I mean, for, for, for Japan, we were really pleased to get, to get reimbursement coverage this quarter. In fact, you know, we've just sort of processed our first patient sample in, in Japan, so, so really positive news. You know, in our, in our guide for, for the remainder of this year for Japan, you know, we've got very minimal revenue in there. Then I think, yeah, we're, we're hoping and expecting in 2024 that that revenue starts to become, become material. I think when we look at Japan as an overall market, you know, it's a, it's a, it's a very large market. It's probably overall half the size of, of the U.S., so we think this can be, over time, a significant contributor for us. At the moment, I think it's a bit too early for us to be really pointing out any specific guidance but for 2024 or specific years. On, on the, on the China side, yeah, that's really gonna help power our biopharma, biopharma business. The lab partnership we've, we've got there enables us to have global offerings to our biopharma partners. We're, we're very excited to, you know, hopefully soon have that lab go live and start to offer products in, in China. Again, it, you know, it's gonna be very incremental to our, to our biopharma business. Appreciate that. In terms of the OpEx guide, you've talked about the sales and marketing spend and the research spend, and that makes sense. Just really specifically, the G&A was sequentially up this quarter. How is that tracking for the rest of the year, for that line specifically? Yeah, the, you know, that line's probably in the, in the second half of the year will be, maybe a little bit lower than, than what we saw in the first half. We, we saw a bit of an uptick in, in this most recent quarter from a, from a legal litigation expense perspective. You know, we've, we've just finalized the Illumina litigation that, that we had. We made a press release on that yesterday or the day before. You know, we're hopeful that, that, that expense can drop off in the second half of the year, and DNA should stabilize going forward. Our next question comes from Patrick Donnelly with Citi. Patrick, please go ahead. Your line is now open. Hey, guys. Thanks for taking the questions. Maybe just one on the biopharma segment, just given, you know, overall concerns on, on kind of budgets and funding there. Can you guys just pull back the curtain a little bit, what you're seeing there, what we should expect on the volume side, from that segment for you? I think it's sort of in line with sort of what we highlighted at the beginning of the year, that, there is a little bit of sort of rejiggering in a bunch of pipelines, and some companies had some layoffs. They're sort of deciding what areas in terms of therapeutic areas to invest next. That was all kind of factored in at the beginning of the year. I think we've been pleased that we continue to diversify our customer base, continue to grow volumes in this sort of challenged environment. We also see this as an opportunity. We're having a great conversation with a number of pharma companies that are really looking for new areas by which to really expand some of their, their pipelines. You know, we have a, we have a very unique platform. It's, We, we think this is in future years, gonna be a very strong growth pattern. Okay, that's helpful. Then maybe just on, on the MRD side, you know, thinking about the, the spend levels, again, you guys have been pretty clear on the, on the, screening piece. Just on MRD, can you just talk about your expectations around the spend there, thoughts on data generation versus kind of driving increased market penetration, again, just how we should think about the, the level of investment around, around that segment? Obviously, a nice growth area for you guys. Well, I'll start, and I'll let Mike sort of fill in, some of the financial pieces. Look, it's, it's, it's an area that requires, a heavy amount of clinical validation and clinical studies. It's something that, we've been, building up for the last four or five years, and, we have a very nice pipeline of studies across multiple indications that, we're planning to essentially process and run. We have these collaborations going forward, and hopefully, we can share, some, some more of that, in the coming months. That being said, you know, we're gonna be very judicious about, how much we, invest, how we space those investments, and how much we invest in terms of, market share. We're, we're continuing to grow really nicely, 100% year-over-year. We're engineering the demand, as we said in the beginning of the year, so that, you know, we're not letting essentially the, the burn sort of get ahead of us, too much. We really see no competition from a tissue-free point of view. We think this is a product category of its own, product category that is gonna be the ultimate winner in this MRD market. We're in a very good spot right now. Yeah, yeah. I mean, maybe just to reiterate that we. Yeah, we've been very sort of judicious on, on the investments we make. That's investments on, you know, pro- as, as well as the market development, and the technical development, but also on just, you know, on processing the samples and running those samples prior, prior to getting reimbursement. We're, we're managing that very, very closely. You know, we've got our, we've got our stated goals on cash burn this year and going forward and on operating expenses this year. We're just, you know, we're closely managing that investment within those parameters that we've set. Our next question comes from Dave Delahunt with Goldman Sachs. Dave, please go ahead. Your line is open. Hey, guys. Congrats again on another strong quarter. Any additional color you could give us on MRD trends? I think I heard you say to Pat's question, you're seeing market share grow 100% year-over-year. Is there any qualitative color you could give us around what are the main selling points that have resonated the most with docs, and what are the main questions they've had? I would say it's, it's really the fact that it's simple. You know, blood test, get the results really quickly, much faster than tissue-informed approaches. Really just the, I think, customer service that we have, the quality of the commercial team, the strength of the commercial team. I mean, there's really, you know, very few oncologists, if any, that haven't ordered a test from us. Really, sort of, being integrated with their, their offices and having that unified experience, I think is another big, big piece. Obviously, as we sort of continue to evolve the platform towards Smart Liquid Biopsy, it's really gonna just change the game in terms of what MRD even means, what MRD has to mean-... Yeah, we're very confident in terms of where things are, are going, in this market and where we are right now. Yeah, we see, really no sort of product out there that, you know, has the same product market fit as we do, especially, you know, in the coming quarters as we continue to upgrade the capabilities of this device. Great. On the screening side, you guys have been super successful in the past with leading the field for liquid biopsy. What do you think is the mix of PCPs who understand the value of blood screening versus the share that would still benefit from more physician education? What we are seeing in the marketplace with Shield LDT right now is, I mean, obviously, for almost everybody, the fact that you can do colorectal cancer screening with blood is a new concept. What they are very well aware of, and in fact, it's helping the brand and acceptance of this offering, is how unpleasant and inconvenient other modalities are. Again, like, we are just promoting this test for unscreened patient population who have not done any kind of screenings or haven't been compliant to other solutions, and these doctors know those patients. They know the patients that, you know, they have ordered other modalities, and they did not complete the test. That is on the top of the mind. Completion is not there, unpleasant experience is there, and that's really helping the brand in terms of acceptance of this new modality. Our next question comes from Mark Massaro with BTIG. Mark, please go ahead. Your line is open. Hey, guys, this is Vidyun in for Mark. Thanks for taking the question. I was wondering when TissueNext and Guardant Response will start to become more material to volumes? Is reimbursement a key gatekeeping item there, or is it more about marketing, and maybe some additional data development? Any color you can share there? Thanks. I mean, I think Mike Bell mentioned that TissueNext is also growing 100% year-over-year. It's been a very good contributor to our business. We're seeing approaching over 200 million covered lives. We obviously have Medicare coverage there. It's a very good franchise for us, strong growth, you know, I think very smartly growing ASPs. It's something that I think is gonna be a big driver for us. It's already becoming a serious contributor to our business. Guardant Response, we just received Medicare coverage there a few months ago, and that's also gonna be a very strong component to our business. Yeah, we're very pleased with both aspects of our portfolio. Okay, understood. Just to dig in a little bit more on a prior question on screening. So I know you've conducted your own PCP survey work. We recently commissioned a survey that showed about 3/4 of primary care docs are looking to order simple blood tests, and over half of docs wanted to order for all or most of their patients. So I'm just curious if you think our data is in a similar ballpark to your current thinking around ordering interest for Shield. Thanks. I heard you right, like three-quarter of the doctors are interested to order at, like, for some, even up to 50% of their patient population. I think in general, it's in line with what we are experiencing, and our survey shows. I think the fact that, again, still there are 50 million of these patients who are unscreened in the field, you know, out of the whole kind of a patient pool of, you know, 120 million. The fact that, again, this unpleasant experience and lack of completion is a known feature of this market for the PCPs, like, these kind of numbers make sense. I'm not surprised with your survey results. Our next question comes from Dan Leonard with Credit Suisse. Dan, please go ahead. Your line is open. Thank you. A question for you, Helmy. You mentioned the EMR integration in your prepared remarks, and that's underway. Possibly, you can quantify the volume lift you're seeing at accounts that you've initially integrated, and how you'd frame the benefit from broader integration. Yeah, I mean, I think that historically, rule of thumb is you get a sort of 50%-100% volume lift at accounts when integration happens. We're seeing that really play out in a number of accounts that we've integrated with. Yeah, we're hopeful as this-- as we continue to make progress there, it's gonna be a strong growth driver. It's just, you know, it's a lot of friction to have to go into another portal or fill out a paper form or a PDF. So being able to just be in an account system, order the test from that same system that they're using for everything else is a huge part of removing friction, and that's a lot of what we're doing in the coming quarters and years, is really building up that customer experience piece. That it really is as seamless as possible to order a Guardant test. Understood. For my follow-up, Helmy, could you elaborate further on the import of Galaxy? I don't recall that being a, a primary point in your talk track prior. Yeah, it's, you know, the- sort of got kicked off with a partnership with Lunit. They're a leader in AI power digital pathology, so really thinking about sort of the spatial genomics and, and spatial biomarker analysis space, and, you know, using AI to sort of read those images. The first application that we launched was PDL1, essentially using AI to read that. It's pretty powerful, even though it's a relatively straightforward application. Being able to find 20% of patients that might have been negative with manual review, as positive for PDL1, has very important therapeutic implications. That's really resonating with a lot of physicians. It's helping to drive our growth in tissue. It's just the beginning in terms of what's gonna be possible as we sort of tie that in to our other tissue testing and even on the, on the liquid side. Stay tuned. Our next question comes from Andrew Brackmann with William Blair. Andrew, please go ahead. Your line is open. Hey, guys. Good afternoon, and thanks for taking the question. Maybe two for AmirAli. First, on the upcoming NCIRE lung readout, can you maybe just sort of level set us on your performance expectations there to sort of what constitutes a success? Then, as a follow-up on Shield CRC, I know it's been asked in the past, but any update to your expectation on whether that goes to an advisory panel or not? Just sort of remind us on how you're thinking about that potential. Thanks, guys. Yeah. For the lung, actually, we've shown a bunch of case control studies. This NCIRE is gonna be actually the first data that even we are gonna see, which is a good indication of the performance of our test in screening relevant patient population, really in a mini screening kind of study. We are waiting to see actually what that data is gonna show. In terms of the bar, I mean, when you look at this space of lung cancer, that the 15 million people at high risk, as I mentioned in the prepared remark, they have the adherence rate of less than 15%. Now that we are doing this study, even we are seeing really the real-world standard of care, that even people are getting diagnosed with some, relatively high-risk nodules, but again, just due to risk factor associated with biopsy, that biopsy is not getting done and sometimes getting delayed till another imaging actually confirms still that even if that large high-risk nodule is continuing to grow. When you look at the reality of standard of care, it gives us a lot of excitement about the opportunity that blood-based screening can put on the table. If I got your second part of question right, about the AdCom panel advisory for Shield CRC, we haven't heard from agency that they wanna call any panel advisory board so far. Probably if they want to do that, we should have heard already, but we'll see. Like, you know, it's agency's choice of what they wanna do but so far, we haven't got any indication on that. The next question comes from Sung Ji Nam with Scotiabank. Please go ahead, Sung Ji, your line is open. Hi. Thanks for taking the questions. Just a couple of quick ones for AmirAli. Maybe with the... Just remind me again, whether the ECLIPSE peer-reviewed publication, is that an important milestone, in terms of, you know, receiving the FDA approval? FDA approval? No. Like, you know, FDA independently, they are looking at all the data and the details of data in their own hand and eyes, so not that peer-reviewed publication. What it's important for is for USPSTF review cycle. Typically, it's they do data reviews when, majority of cases when the evidence is published in peer-reviewed journal, and we wanna check that box, and we are on track. You know, so we've done our part, and we'll see, but, we should be able to have that paper published before end of the year. Okay. Got it. Then for, lung cancer screening, you talked about, I realize it's less than 15% screening. Is that largely driven by primary, the primary care market today? Just kind of curious what the educational process might, you know, entail with a new modality of testing, and whether you might need to involve the you know, pulmonologist. Still, we are kind of learning about bunch of details of that market as we speak, but, you know, at, at, at high level, just it's a modality of screening that needs significant patient commitment and follow through. ... A multiple round of imaging, biopsies, still a large fraction of biopsies would not indicate patient has cancer. Adverse events associated with those biopsy. It's a journey which is very hectic, long, and needs a lot of commitment. In fact, we are not very surprised that the adherence rate is much lower than CRC. We are continuing to learn more details about the market dynamics. Our next question comes from Liz Garcia with UBS. Please go ahead, Liz, your line is open. Great. Thanks so much for squeezing me in, guys. I just wanted to circle back on Response. I know, obviously, kind of one of the smaller assays, but I think, last quarter, you had kind of indicated maybe like a low single-digit contribution, revenue contribution, was what to think about. I was wondering, I know, you know, clinical volume trends have just been doing pretty well, if that was the right way to think about this assay still. You know, just with another quarter kind of under your belt, if you had any clinician feedback, just given that maybe other assays kind of work a little differently in the treatment monitoring space and you know, what you're hearing there? Then a follow-up. Yes, my case. I'll take the financial piece. I think, maybe on the last earnings call, you know, when asked about what contribution will response deliver now this year? We've received Medicare reimbursement. You know, it's very early days since Medicare reimbursement, and I think we mentioned very low single-digit million dollar revenue that would come from response. That's still the case. I think on the second part of the question. Yeah, no, I mean, I think it's the, the beauty of this is that, you know, right now, the sort of leading product and therapy selection, liquid biopsy in the space is Guardant360. It's the fact that they work in conjunction with one another is a huge advantage that we have. It really works in a pretty straightforward fashion in terms of mapping tumor burden quantitatively. It's a product that I think resonates well. One that we're continuing to promote much more aggressively now that we have reimbursement behind us, at least on the Medicare side. We think it should be a very important growth driver for us coming years. Great. Awesome. Just one last one on the EMR integration. You know, I think you, on a prior question, you cited some pretty big increase in utilization from oncologists ordering when EMR integration happened. And obviously, I think you mentioned integration with two-thirds of oncology practices just finished, and so I was wondering if that happened in this quarter. To kind of think of 2Q, is like that kind of happening or, you know, if you could just provide some context around kind of that increase in ordering and kind of how that happens or some kind of timeline, that 100% figure. It'd be great to kind of dig into that a little bit more. Sure. Thanks. Yeah, just to be clear, we're just starting the integration. We've done a lot of the work in terms of being able to integrate with those vendors that comprise about two-thirds of the market. There's still work to do on the account side, where we have to turn them on one by one, many of them. We're in the early innings of that. We're very pleased with initial progress in a handful of accounts that we've integrated with. You know, it's a multi-year journey to turn all of these things on. Our final question today comes from Rachel Vatnsdal with JP Morgan. Rachel, please go ahead. Great, thank you. This is Casey Woodring on for Rachel. Thanks for taking our questions and squeezing us in. I guess just two quick ones for you. On the CDx side, can you talk about what's next in the pipeline in terms of maybe other indications or areas you're targeting for approval and timelines around some of those and, you know, when you'd expect or if you'd expect similar volume ramps to the ESR1? I think last quarter you said breast volume ticked up 40% right after that approval. My second question is just on the biopharma business. I think last quarter you talked about plans to expand into China. Is that still on the table this year? You know, the companies that we've heard from so far that have been reporting have flagged, you know, material weakness in China. Is that still on the table this year? You know, thoughts around that? Thank you, guys. Yeah, good questions. Yeah, I mean, we have a whole host of, you know, at CDXs that we're either negotiations with or have, you know, have signed on, a bunch of other ESR1s, but yeah, other indications as well. I think that's opportunity ahead of us in terms of, you know, being able to, partner with, new classes of therapeutics or, biomarkers and other indications, to see hopefully, similar, volume uplifts, in other indications, in the future. In terms of China, you know, we're starting at zero right now, so, you know, there's a total upside at this point. Yeah, we're very pleased with the progress, we've, we've been making, a strong partnership with, with Adicon over there. We should be up and running by end of this year, there's a very strong pipeline in terms of biopharma partners that want to be able to test samples in China. There's a vacuum right now in terms of sort of global companies that have the scale that we do that can operate in China. We see maybe that weakness that maybe others are facing there as a strength for us. We are moving very nicely in terms of progress there. We have no further questions, so I'll turn the call back to the management team for any closing remarks. Well, thank you. Thank you everyone for joining us today. This concludes our call, and you may now disconnect your lines.