Good afternoon, ladies and gentlemen, and welcome to the Guardant Health Q3 2019 Earnings Conference Call. At this time, all participants are on a listen only mode. Later, we will conduct a question and answer session and instructions will follow at As a reminder, this conference is being recorded. I will now turn the conference over to your host, Ms. Carrie Mendiville.
Please go ahead.
Thank you. Earlier today, Guardant Health released financial results for the quarter ended September 30, 2019. If you have not received this news release or if you'd like to be added to the company's distribution list, please send an e mail to investorsgardenhealth.com. Before we begin, I'd like to remind you that management will make statements during this call that are 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.
Additional information regarding these risks and uncertainties appears in the section entitled Forward Looking Statements in the press release Carden issued today. For a more complete list and description, please see the Risk Factors section of the company's annual report on Form 10 ks for the year ended December 31, 2018, and in its other filings with the Securities and Exchange Commission. Except as required by law, Guardant disclaims any intention or obligation to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of the live broadcast November 7, 2019. With that, I'd like to turn the call over to Helmy Elkafi, Guardant's Co Founder and CEO.
Helmy?
Thanks, Carrie, and thank you, everyone, for joining us this afternoon. I'm pleased to welcome you to Guardant Health's Q3 2019 earnings call. Joining me today is AmirAli Talasaz, our President and Co Founder and Derek Bertocci, our Chief Financial Officer. Consistent with our values of putting patients first, I will start our call with a patient story. Over a decade ago, a 69 year old physician was diagnosed with stage 2 prostate cancer.
By 2018, his cancer had become metastatic and was progressing despite an androgen deprivation therapy. With a rising PSA score and unpleasant side effects from his therapy, he discontinued treatment, closed his private practice and began making end of life care decisions. Looking for another option, his oncologist ordered a Guardant360 test, which quickly identified a somatic BRCA2 mutation. His doctor immediately started him on a PARP inhibitor therapy, which has demonstrated promising data in BRCA mutated prostate cancer. 9 months later, this patient is alive, stable and back at work, once again caring for his patients.
We believe this story demonstrates the growing importance of the precision medicine paradigm in oncology, not just for lung cancer patients, but increasingly for patients across many cancer types. Establishing a new standard of care for patients, however, is not simple and requires generating evidence of superior clinical utility to support broad reimbursement and clinical adoption for such new approaches. At Guardant Health, we are committed to such investment aimed at advancing clinical utility across the continuum of cancer care. In the treatment selection market, for example, with Guardant360, we initially focused our efforts in non small cell lung cancer where we believe the limitations of tissue created a clinical gap in comprehensive testing. Through investments in high impact clinical studies, we are able to quickly establish clinical utility in lung cancer, which in turn has helped decrease plan to reimbursement, approve physician conversion efficiency and lead to record clinical adoption.
Our investments, along with our many collaborations with leading cancer centers and pharmaceutical partners, have led to over 130 peer reviewed publications and over 400 scientific abstracts detailing clinical evidence supporting our platform across dozens of cancer types. For instance, at the recent European Society of Medical Oncology Conference in September, results from the TRIUMPH study demonstrated that patients with metastatic colorectal cancer with a HER2 amplification detected by the Guardant360 assay experienced clinical benefit from HER2 directed combination therapy. These results strongly suggested that Guardant360 can identify patients with HER2 amplified metastatic colorectal cancer who could benefit from the dual HER2 targeted therapy. As we have mentioned previously, in addition to strong clinical data, we believe FDA approval of Guardant360 will be an important catalyst for helping to establish a blood first paradigm that will lead to continued clinical adoption of Guardant360. Over the last 2 years, our team has been working diligently on analytical and clinical validity studies to support our pre market approval application for Guardant360 in what we believe would be the first of its kind submission.
Today, I am happy to announce a very important milestone for the company and for the precision oncology space and that we have recently submitted our PMA package for Guardant360 to the FDA. We also believe that a final Medicare pan cancer LCD could be issued by the end of the year. As a reminder, this LCD could potentially expand Medicare coverage of the Guardant360 assay to over a dozen advanced solid tumor cancer types with guideline recommended genomic targets. These tumor types represent the vast majority of all solid tumors. The draft LCD applies to advanced cancer patients who are covered by Medicare for next generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples.
This is an important step towards ensuring all Medicare beneficiaries with advanced cancer have timely access to guideline recommended treatment options. We are encouraged by the increasing demand for our products and in particular, GuardantOMNI from our biopharma partners. GuardantOMNI offers our partners the opportunity to identify patients who may respond to immuno oncology agents as well as target therapies. For example, an area of growing interest is identification of patients with homologous repair deficiency gene signatures who may be candidates for a class of targeted therapy known as PARP inhibitors. The continued robust progress across every segment of our business translated to another exceptionally strong quarter with total revenue growing 181% year over year to $60,800,000 Over the same period, clinical volumes grew 89% to 13,259 clinical tests and biopharmaceutical volumes grew 111 percent to 5,280 tests.
As a result of this progress, we now expect revenue for 2019 to be in the range of $202,000,000 to $207,000,000 reflecting growth of 123% to 128% over 2018. Before I turn the call over to AmirAli to discuss the details of our LUNAR programs, I would like to mention that Arav Hillelli had stepped down from our Board of Directors following his departure from Sequoia Capital. I want to take a moment to thank Arav for his guidance and contributions to Guardant over the past 4 years. With that, I will now turn the call over to AmirAli.
Thanks, Helmy. Similar to our clinical development and commercial path with Guardant360 in starting with lung cancer as the lead indication, we are taking a similarly focused approach with our LUNAR programs. Starting first with our LUNAR-one program, where we are developing an assay for adjunotherapy utility is a critical component to drive sustained long term adoption in the recurrence monitoring space. One of the challenges in this space will be the demonstration of clinical utility through prospective interventional trials. That is proving that earlier detection of residual disease or recurrence can lead to an improvement in patient outcomes.
We believe this will be critical to changing clinical workflows and establishing reimbursement from a variety of payers. To this end, I'm very pleased to announce that we have clinically validated our LUNAR-one assay and have launched a clear version of this assay for prospective clinical trials. In addition, we are planning to initiate a prospective interventional study for adjuvant therapy selection in colorectal cancer in the near future. Now moving on to LUNAR-two. We've been diligently advancing our colorectal cancer screening program forward where we believe that blood based assay could add tremendous value when looking at the existing rates of patient compliance with available screening tools.
A few weeks ago, we announced the enrollment of the first patient in our ECLIPSE study, which is a prospective multi site registrational study designed to support the introduction of our NUNAR-two assay were used in guideline for common colorectal cancer screening in average risk adults. The study's primary objective to evaluate the performance of the LUNAR-two assay to detect colorectal cancer and advanced neoplasia specificity during screening. The study also includes secondary endpoints evaluating the assay sensitivity related to polydetection. Over the next 24 months, we plan to enroll about 10,000 individuals aged 45 to 84 or at average risk for colorectal cancer across about 100 sites in the United States. To our knowledge,
this
is the 1st blood based screening trials of this magnitude. We are encouraged by our early discussions with both FDA and CMS and believe that if successful, this regulatory grade study will pave the way for FDA approval of our LUNAR-two assay and later CNS coverage, both of which are critical durable long term clinical adoption. We are very excited by our rapid progress as well as the positive reception we continue to receive from important stakeholders in this space. They agree there is a critical gap in the screening landscape for colorectal cancer, which is known to be effective in saving lives. In fact, the U.
S. Prevention service task force recommends screening average risk adults for colorectal cancer starting at age 50 and continuing through age 75. Yet, despite the guidelines and established clinical evidence, about 1 third of adults in the United States who should be screened do not comply, citing that the current screening methods time consuming, unpleasant and in case of colonoscopy invasive. Our blood based assay is intended to improve screening compliance by removing barriers associated with current testing methods. Because blood tests already play an integral role in medicine, we believe our test could significantly increase adherence with screening guidelines and fill the compliance gap that exists today.
We look forward to building the clinical evidence needed to ensure production of our assay commercially and drive clinical adoption. With that, I will now turn the call over to Derek Bertocci for more detail on our financials. Derek?
Thank you, AmirAli. Revenue for the Q3 of 2019 totaled 60,800,000 dollars up 181 percent from $21,700,000 in the prior year quarter. 3rd quarter revenue included $5,500,000 due to payments received in the quarter from successful appeals of payers denial of reimbursement for samples processed in 2018. Given the age of the samples associated with these successful appeals, the company does not believe this appeals revenue is indicative of ordinary course operations. Increases in both volume and ASP for clinical testing plus higher volume for biopharma testing were the prime drivers of the increase in revenue.
Development services, primarily companion diagnostic programs, also contributed to the increase in revenue. Total precision oncology revenue in the 3rd quarter was $52,100,000 up 185 percent from $18,300,000 in the prior year period. Precision oncology revenue from clinical tests in the 3rd quarter totaled $30,800,000 up 2 44 percent from $9,600,000 in the prior year quarter due to increases in both volume and ASP. This included the $5,500,000 of revenue from Apeal's 2018 samples. 3rd quarter clinical precision oncology volume totaled 13,259 tests, up 89% from 7,027 tests in the prior year quarter.
This increase was mainly due to reimbursement by Medicare for lung cancer patients starting in the Q4 2018, plus increases in commercial payer payments that were beneficially affected by the Protecting Access to Medicare Act of 2014. Precision oncology revenue from biopharmaceutical tests in the 3rd quarter totaled 21,400,000 dollars up 145 percent from $8,700,000 in the prior year quarter due to growth in the number of programs that biopharmaceutical customers brought to Guardant Health, particularly for use of GuardantOMNI. 3rd quarter biopharmaceutical precision oncology volume totaled 5,280 tests, up 111% from 2,505 tests in the prior year quarter. Average revenue recognized per biopharmaceutical test in the 3rd quarter was $4,052 up 16% from $3,491 in the prior year quarter due to a greater number of GuardantOMNI tests, which has a higher selling price than Guardant360 test. Development services revenue in the 3rd quarter totaled 8,700,000 dollars up 156 percent from the prior year quarter due to an increase in projects from biopharmaceutical customers active in 2019, mainly for companion diagnostic development and regulatory related services.
Gross profit is total revenue, less cost of precision oncology testing and cost of development services. Gross profit for the Q3 of 2019 was $42,300,000 compared to a gross profit of $11,600,000 in the same period of the prior year. The gross margin in the Q3 was 70% as compared to 54% during the Q3 of 2018. These results are inclusive of the benefits of the $5,500,000 of appeals revenue. Gross margin improvement was primarily due to the increase in average revenue per clinical and biopharmaceutical tests.
As a reminder, effective January 1, 2019, we adopted the new revenue accounting standard, ASC 606, using the modified retrospective method, which means that revenue reported for 2018 is not restated in our 2019 financial statements. Instead, the accumulated difference resulting from applying the new revenue standard to all contracts that were not completed as of adoption was recorded to opening accumulated deficit as of January 1, 2019. The effect of the adoption of ASC 606 was to increase Q3 revenue by $1,100,000 compared to the revenue that would have been reported without adoption of ASC 606. The effect of this change is disclosed in our Q3 results press release. Total operating expense for the Q3 of 2019 was 59,800,000 dollars a 67% increase from $35,900,000 in the Q3 of 2018.
R and D expenses for the Q3 of 2019 were $24,600,000 compared to $14,300,000 in the Q3 of 2018. The increase was primarily attributable to work to prepare the Guardant360 IVD submission to the FDA, development in clinical studies for the LUNAR program and additional clinical studies improvements to processes and products. Sales and marketing expenses for the Q3 of 2019 were 18,800,000 dollars compared to $13,500,000 in the Q3 of 2018. The increase was due to expansion of our commercial organization to drive increases in revenue. General and administrative expenses for the 3rd quarter were $16,400,000 compared to $8,100,000 in the Q3 of 2018.
This increase primarily due to increases in personnel, professional services including legal and accounting and costs required to support the transition to a public company. Net loss attributable to Guardant Health common stockholders was $12,800,000 compared to $24,500,000 in the Q3 of 2018. Net loss per share attributable to Guardant Health common stockholders was $0.14 per share in the Q3 of 2019 as compared to $1.94 per share in the corresponding period of the prior year. We ended the Q3 of 2019 with $825,600,000 in cash, cash equivalents and marketable securities. As Helmy mentioned, we are updating our revenue guidance.
For the full year 2019, we expect revenue to be in the range of $202,000,000 to $207,000,000 representing growth of 123 percent to 128% over 2018. Our previous revenue expectation was $180,000,000 to $190,000,000 We now expect clinical sample volume for 2019 to be approximately 48,000 tests compared to our previous expectations of 44000 to 46000 clinical samples. We now expect net loss in the range of $75,000,000 to $80,000,000 compared to our previous expectations of $112,000,000 to $115,000,000 This estimate includes costs associated with the start of our ECLIPSE clinical trial in the Q4 of 2019. With that, we'll now open it up to questions. Operator?
Our first question comes from the line of Brian Weinstein with William Blair. Please go ahead.
Hi, guys. Good afternoon. This is actually Andrew Brackmann on for Brian. Maybe we can just first start off with a high level question around adoption of G360. What you're seeing there?
What sort of institutions from a high level are sort of the ones where you're getting the deepest sort of penetration? Is that an academic hospital, large IDNs or community hospitals? And how does that compare to what you had thought before in the year? Thanks.
Yes. Good question, Andrew. So we're actually seeing a pretty similar trend to what we've been seeing for the last few quarters with NILE, with the expanded sales force and with I think some of the clinical data that is giving more confidence to use of really robust growth on really robust growth on the community side. And so historically, years ago, we have been weighted on the academic side. And now, I think just about 60% of our volume is in the community.
And that's where we're seeing, I would say, the fastest growth right now of adoption, which is where you want to be because about 80% of oncology is practiced in the community setting.
Got it. Thanks. And then just one on guidance, as we sort of think about the last sort of several quarters, we've obviously seen blown away sort of the consensus expectations. How should we think about you guys? What are sort of the puts and takes in order to get to that low end of the range?
And then one, Derek, are there any other additional one time payments associated in that guidance? Thanks.
So in the guidance, there are not expectations of any one time, So you should be thinking about the revenue in Q3 excluding that as you think about looking forward. In terms of the guidance, we think that this is a prudent guidance relative to what our expectations are. We had indicated at the outset of the year and we've reminded the analysts that our pharma business would be heavier in the first half and we're seeing that exactly in the results. We still see that our pharma business in terms of programs that pharma customers are bringing to us is very robust. We just had a bit more of their activity happen in Q3 than we originally anticipated.
Thank you.
And your next question comes from the line of Tycho Peterson with JPMorgan. Please go ahead.
Hey, thanks. Nice quarter. Question, I guess, with the Palmetto LCD getting finalized into year end, but then you've got the NCD coming in Q1. I mean, is the Palmetto LCD effectively moot once the NCD rolls in? Or what's the importance of getting that in
place? Yes. So we look at the 2 as really parallel pathways in terms of securing pan cancer Medicare coverage. And so I think it's nice to have the optionality of both pathways in terms of being able to secure what we believe is going to be the largest step function in ASP increase for our clinical volume. And so we believe, yes, the LCD should get finalized later this year.
The NCD, we believe that will be kicking in essentially probably a quarter after our FDA approval of Guardant360. And so and the review cycle is, I think, formally 6 months from submission. So we certainly think that the LCD would be something we can draw on well before the NCD.
And then Helmy, are you able to talk on progress with the Japan JV, other kind of milestones we should be paying attention to over the coming
quarters there? We continue to make excellent progress there. We're seeing now thousands of samples that we're processing in Japan, and as well as in Southeast Asia. And so our joint venture with Southbank continues to make good progress. We believe our FDA package is important not just in the U.
S. But internationally since it's that data that will be used in our submissions to other regulatory bodies such as the PMDA. And so the team is working diligently on some of those activities of translating that work into the form factor required for the PMDA in Japan. So I think probably nothing specific to update at this time, but we're very pleased with the progress there.
And then on CGP comprehensive genomic profiling, that's been stuck at around 15%. Can you just talk to what it takes to move the needle there?
You mean in terms of penetration into the Correct. Yes. From what we can estimate, it's in the 15% to 20% range in terms of tissue or liquid comprehensive genomic profiling penetration. I think we are seeing as more targeted therapies become available, obviously, the NCCN guidelines have been updated from just a few markers to now 8 biomarkers for NCCN Lung Cancer. We saw PIK3CA recently added as an option for breast cancer patients.
And so it's going to take this multi factorial effort to, I think, move the needle to really ensure that the comprehensive genomic profiling is done for newly diagnosed metastatic patients at the first line setting. And so the good news there is, I think we are seeing that move and we're seeing that needle move and it's not just us that is putting the effort in. It's really the whole space and all the pharmaceutical companies that are selling into that market are helping as well. So, yes, we're very confident that that's going to continue moving in the right direction.
Okay. And then one follow-up before I hop off. You've mentioned SoftBank before. Obviously, a lot of people are focused on their ownership. Are you able to talk to your dialogue with them and your interactions?
Obviously, there's fear they'll come back to market.
I can tell you at the Board level, I think everyone is very positive about Guardant and our future prospects in this space. But we can't comment on any individual investors' holdings in general.
And your next question comes from the line of Doug Schenkel with Cowen. Please go ahead.
Hey, good afternoon guys and thank you for taking my questions. Maybe just a quick follow-up to one of Tycho's questions on the submission to the FDA, the PMA package. It sounds like the answer to both of these is yes. But just to confirm, are you officially pursuing the dual path process? And based on what you submitted to the FDA, is the expectation that this will support a pan cancer label without any requirement for insufficient
tissue? So I'm really here. So what we believe is based on the interaction that we had with reguifacial CMS is we don't need to go through a separate parallel review cycle for Guardant360 or benefit from NGS and CD. We just need to get the FDA approval and have the FDA label which matches the coverage criteria of the current NGS and CD. There's been some recent changes there that didn't really impact our test.
And regarding like tissue insufficiency or not, that's the current language in our draft coverage policy by Palmetto. And for NCD, it really believes on the final label that we can get from FDA post approval. So it's really too early to comment around the impact of NCD on tissue.
Okay. Okay. That's helpful. Thank you for that. So this was clearly another great quarter on multiple fronts, I would say, especially on the clinical side where you had great sequential and year over year growth.
Anything special to call out there? Or is this really just continued execution and follow through on Nike and the more efficiency with the expanded sales force?
Yes. I think we're continuing to see some benefits from NILE, from the sales force expansion and so on. But I think as we've communicated in the past, to really get to catalysis of the market. It's really going to require the 3 pieces. Now we have under our belt with this FDA submission.
Hopefully, we'll have soon FDA approval. And then with the LCD, we should have that pan cancer reimbursement. And so I think we've been we've seen probably better than expected uplift in advance of some of those factors. But I think the good news is we're kind of swimming in where the river is flowing, so to speak. Clinical comprehensive genomic profiling is becoming more and more something that is a requirement for advanced cancer patients.
Our test Guardant360 is really the simplest way for physicians to get that information and the quickest way. And so I think what you're seeing is some of the, obviously, investments we have made, but the fact that we're in the early innings of a large market opportunity here.
Okay. That's great. One last one. I may have missed this in the prepared remarks, but I don't think I heard any update on covered lives. Again, I apologize if I missed it.
I think you guys were around 100 and $60,000,000 last quarter. Any update at this point?
We continue to add plans, small plans here and there, but I would say no substantive update at this time.
Okay. Thank you again.
Thank you.
And your next question comes from the line of Derik De Bruin with Bank of America. Please go ahead.
Hi, good afternoon.
Hi. Hi Derik.
Jason. A couple of questions. One, great to hear that you submitted Guardant360 FDA. Can you give us a sense of timing on how long it will take to PMA, so I'm assuming it's in the 6 to 9 month range?
So we have breakthrough device designation for Guardant360 from the agency and the typical review process is going to be like 6 months instead of 9 months. Having said that, like we have to go through this review cycle and see how that review cycle goes in terms of back and forth with FDA and maybe different questions that they're going to have for us. As we make more progress there, it could become more obvious for us what could be the timeline for FDA approval. But as I mentioned, typically for breakthrough device designation, the typical timeline is about 6 months.
Great. And on the ECLIPSE study, enrolling now, 24 months' time, I guess, any sense from when you would have first the first sort of look at data coming out? And just a couple of questions on, have you already locked down the assay and is everything ready to go and start analyzing as of now?
Yes. So the plan is actually the enrollment could take up to 24 months, maybe a little bit shorter than that. And once we have the samples, we are going to run them with the PMA package and submit the evidence that we have for FDA review with the hope of getting PMA approval since the ECCLIP study is really designed to be a regulatory great study for us. In terms of assays, we mentioned earlier, like the technology that we presented our pilot data is basically the same thing, the assay is the same thing. We are in the middle of IVD product development of that assay, which means just making the IVD version of that assay.
Similar process that Guardant360 went through. We had Guardant360 technology for a long time and then we made the IVD version of it. You have to go through some kind of process and hide some of the loose ends in our fab to IVD versions. So we are in that process for JUNAR and we have a lot of time till the last patient in and we believe we can easily meet those timelines, but the IVD version of the assay ready to run the Eclipse samples.
Great. And then just one final question for Derek. This quarter, my R and D was way too high and my actually my SG and A was way too high and my R and D was way too low this quarter if I'm just modeling. Can you give us some sort of guidance on the trajectory for both of those sort of OpEx lines?
So as you can see with our guidance, we're assuming that we continue to grow our activity. So I think if you use Q3 as a baseline, there would be increases in R and D as we continue to pursue the LUNAR program, both development and the clinical trial, which has now started enrolling. So that should go up. We would expect to see some modest increases also in sales and marketing as we're continuing to try and increase our efforts there and we will be adding some reps to increase our efforts there. I think the figure increase would be in R and D.
Thanks.
And your next question comes from the line of Mark Massori with Canaccord Genuity. Please go ahead.
Congrats on a great quarter. A lot of my questions have already been answered, but one subtle nuance of CRC screening, Exact Sciences is enrolling patients beginning at the age of 40 and up, and I believe Eclipse is looking for 45 to 85. I recognize this is a subtle nuance given the size of the market, but do you have any commentary around just that age cutoff, whether it's age 50, 45 or 40 and how you may address potentially a lower age market in the future?
So, actually, some of the details of this study that we've put together was after consultation with FDA and we believe actually the study that we are doing would be a very reasonable study for FDA to start looking at the evidence with the goal of paving the path for getting PMA approval for it. 40% to 45%, it's something which is not on the scope for ECLIPSE study at the moment. Yes, so we cannot comment on the detailed design of other companies why they're trying to do that.
Yes. It's also a moving target. You see as many of the different kind of agencies and so on and groups have different age recommendations in terms of what they believe is, I think, viable and beneficial from a population health point of view. And so I think that's probably something that's going to continue to be a moving target, I think, as the space evolves and something that we're going to continue to track.
Great. And then on LUNAR-one, obviously, you've talked about the clinical validation for research use. You also talked about initiating a prospective adjuvant study for colorectal cancer. I guess what I'm really trying to get at is when do you expect to launch LUNAR-one for the clinical monitoring? And do you intend to initiate the monitoring in the clinic with colorectal cancer initially?
So as we mentioned in the remarks, we believe there are some work that needed to be done in the field to generate additional clinical utility data to show that really looking at the minimum residual disease in different cancer types would generate patient outcome benefit. We decided to have a clinical version of the assay, which we are very excited with this development now and the progress our team made and initiate a major prospective interventional study that based on what we find in the blood, do something differently on the patients and show what would be the outcome benefit for patients. We believe this is the right next step in terms of giving access to our clinical grade test for clinical testing in markets still is early to comment.
Great. And maybe on the commercial side, I know you've made a significant investment in your sales force this year. But as we think about a really large market, only roughly 15% penetrated, I think there is at least one other CGP lab company out there with 1 or 2 with larger sales forces. It's obvious your existing sales force is extremely efficient. But can you maybe just give us an update on the size of your U.
S. Sales force today? And do you see an opportunity to make some additions in 2020?
Yes. I think and I'll maybe take a step back and kind of just tell you the philosophy we have. It's all about efficiency and continuing to see the right number in terms of revenue per rep. And so I think the way we think about it is, as long as we continue to see productivity gains, as we expand the sales force in multiple waves, we're going to continue to be doing that. And we essentially want to see marginal contribution per rep.
That's close to the $2,000,000 range in terms of ASPs and basically sawtooth around that as we add additional waves. So I think we're going to continue to be aggressive, not just in terms of adding account executives to our team, but really thinking about all of the different channels, in terms of sales and marketing, whether it's digital marketing, whether it's co promotions with other organizations. I think we're evaluating all of those different and investing in all those different avenues and aggressively growing them where they can be accretive.
Great. And the last one for me. Your pharma volumes were outstanding, triple digit growth. Can you talk about maybe your funnel for companion diagnostics? As we think about 2020, can you give us a sense of the interest to do similar deals like what you have with AstraZeneca for instance?
Yes. So the pipeline looks extremely strong. We're seeing a lot of interest in really being able to leverage Guardant360 and the fact that it's out there today, it's already being used for patient care, that gives our partners a running start when they think when they're thinking about their drugs and being able to get patients tested for those drugs as quickly as possible. We think certainly having FDA approval behind us is only going to accelerate interest and adoption of the G360 platform for companion diagnostic work. So we are really seeing, I think, a pipeline that is very robust and just continues to grow every month.
Great. Thanks, guys.
And your final question comes from the line of Puneet Souda with SVB Leerink. Please go ahead.
Yes. Hi, Helmy, Amarillo. Congrats on the quarter, first of all. My first question is on LUNAR-one, a juvenile trial that you highlighted here. When should we expect a readout?
And if you can give us some metrics around what the potential for reduction in times of these adjuvant trials and where the adjuvant reduction in the trial sizes as well. And is this only one biopharma partnership here? Just can you if you can give us sort of what's your expectation here in the near term? And on that point, also if you could remind us what's unique about the LUNAR assay as a tumor naive assay versus the tumor informed approaches that we're seeing in the market? Where could a tumor naive be most beneficial?
Yes, sure. So actually we are very excited about this clinical validation of ZONER-one and this prospective study that we are going to do with our partners, please stay tuned very soon. Hopefully, you're going to have a lot more information about the study. Although I wish I could have told you more details to our other partners involved that we cannot tell you more right now, but please stay tuned very soon. You're going to hear some interesting announcements about LUNAR-one.
In terms of why we think our product is better, In our LUNAR assays in general, we are looking at somatic mutation and epigenomic variation altogether. And for LUNAR-one, we are specifically looking at somatic mutation and methylation signatures in blood. We know prior information about the tumor, but just the fact that we are adding somatic mutation and epigenomic mutation gives you a lot of opportunities in terms of having a much better test in terms of performance. And now if you add the logistical challenges of finding an old tumor and personalizing an assay based on what you find on that tumor tissue, I think, could imagine would generate a lot of kind of logistical challenges at least from our perspective. We are very excited about what we are doing the performances that we've seen so far when we are mixing genomic and epigenomic signals together.
Okay. And if I could ask on the clinical growth, obviously, very strong growth here. Can you elaborate on the mix of tests that you're getting from newer oncologists or more of a community setting versus new centers or versus prior centers that you've had? And in terms of the expectations of newer centers at and the sales force where you stand currently? Can you continue to drive that with the existing sales and commercial force you
have? Yes. So, I think as we commented earlier, we've certainly seen tremendous growth in the community setting. We're now about 60% And so we're seeing a repeat use of Guardant360, And so we're seeing repeat use of Guardant360 grow. But we're also continuing despite us being 4 or 5 years post commercialization, and many thousands of oncologists that have ordered the test, we're still adding new oncologists per month really at a record pace.
And so we're seeing, I think, robust signals of growth across really those three metrics, which are the signs you want to see in terms of continued penetration into the clinical market, at least clinical oncology market.
Okay. And then if I could ask on Omni, what's been the feedback from biopharma overall? Are they really utilizing the broad menu of genes here, 500 or so, and the features? If you could talk about, are you seeing demand for those features and specifically sort of for TMB? And my question mainly on TMB is, there seems to be more sort of questions and around it rather than conclusions among the biopharma data that we have seen so far.
You have a unique vantage point. What's your view on TMB overall? Thank you.
Yes. So I think there's certainly been an ebb and flow around tumor mutational burden. We see TMB as one step along a continuum and a paradigm shift to using a lot more genomic information to segment patients than using single biomarkers or using single proteins and so on to do that. So regardless of where TMB, I think, shakes out, that approach is something that is certainly the precision medicine informed approach or genomic informed approach is certainly where the puck is heading. And so I think as we mentioned in our prepared remarks, you need pretty complex genomic information for things like homologous repair deficiencies, for PARP inhibitors.
We're seeing a lot of markers of interest that are outside of what Guardant360 happens to offer, now becoming in vogue and really seeing the pendulum, I think, swing backs from immuno oncology to targeted therapy development as well, which is a nice sweet spot, really seeing both sides of the drug development picture really kind of move aggressively forward. We're seeing a lot more competition in this space. And so a lot of our biopharma partners really want to understand as much as they can about their drugs and their assets so that they can be as competitive as possible. And that's really where GuardantOMNI, I think, fits in terms of being able to provide that information that can be useful.
All right, great. Thanks. Congrats on the quarter.
Thanks, Puneet.
And I'm showing no further questions at this time. I would now like to turn the conference back to Helmy Ottiki for closing remarks.
Well, thank you again, and we look forward to talking again at our next earnings call. Thank you.
Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.