I would now like to hand the conference over to your speaker today, Ms. Carrie Mendivil. Thank you. Please go ahead, ma'am.
Thank you. Earlier today, Guardant Health released financial results for the quarter, and full year ending December 31st, 2020. If you've not received this news release, or if you'd like to be added to the company's distribution list. Please send an email to investors@guardanthealth.com. Joining me today from Guardant Health is Helmy Eltoukhy, Chief Executive Officer. AmirAli Talasaz, President, and Mike Bell, Chief Financial Officer. Before I 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 Guardant issued today.
For a more complete list, and description. Please see the Risk Factors section on the company's annual report, on Form 10-K for the year ended December 31st, 2020. And in its other filings with the Securities and Exchange Commission. This call will also include, a discussion of certain financial measures. That are not calculated in accordance, with generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure. May be found in today's earnings release, submitted to the SEC. 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 February 24th, 2021. With that, I'd like to turn the call over to Helmy.
Thanks, Carrie. Good afternoon, and thank you for joining our Fourth Quarter and Full Year 2020 Earnings Call. We founded Guardant with a mission to improve outcomes for patients, across the continuum of cancer care. The cornerstone of everything we do at Guardant, is motivated by this commitment to serve patients. I am particularly encouraged by the resilience, and perseverance of our team. To maintaining this commitment, despite the strain that the pandemic. Has presented to the care delivery systems in the U.S., and abroad. Consistent with these values, I will start off our call with a patient story. Shortly after giving birth, a 43-year-old woman was diagnosed with metastatic cancer. By the time of her diagnosis, her cancer had progressed so aggressively. That she was not a candidate for chemotherapy. She was extremely weak, only able to drink a bit of water throughout the day.
The hospital immediately brought in palliative care, and began making plans to bring her to a hospice. At the same time, her oncologist ordered a Guardant360 test. And received the results, within a matter of days. Results showed a RET mutation, and her oncologist was able to confirm with a PET-CT scan. That she had non-small cell lung cancer. He immediately made the decision, to put her on GAVRETO. A targeted therapy for patients, with RET-positive metastatic non-small cell lung cancer. It arrived the next morning, and the patient was able to begin treatment just 18 hours. After getting her Guardant360 test results. Within four days, she was already showing encouraging progress. She was much more alert, and awake. Eating throughout the day, and able to hold her newborn daughter.
Her story demonstrates, how critical time can be. When treating patients with aggressive late-stage cancers. And how our liquid biopsy platform can rapidly produce results. To enable oncologists to make quick treatment decisions, and match them with cutting-edge therapies. There is no doubt that 2020, was an extraordinarily challenging year. I could not be more proud of the Guardant team, for their steadfast commitment. To serving cancer patients, in our core business. As well as our recent efforts, to alleviate the testing gap during the pandemic. By assisting with COVID testing, for underserved communities. Despite all the macro challenges throughout 2020. We continued to make important progress. Across both our commercial business, and product pipeline. We ended the year with $287 million in revenue, growing 34% over 2019. In therapy selection, clinical volumes for Guardant360 grew 27% to 63,254 tests.
Clinical growth was strong, despite a virtual selling environment, a nd widespread office closures. Which recent data has shown resulted, in a 65% decline in new patient diagnoses this year. We continued to make progress on the reimbursement front. And now have more than 200 million covered lives, for non-small cell lung cancer. And more than 100 million covered lives for multi-cancer testing. This progress in reimbursement led to 70% growth, in our clinical revenues compared to the prior year. We received FDA approval for Guardant360 CDx, for use in any solid tumor cancer. And as a companion diagnostic, to identify non-small cell lung cancer patients. With EGFR alterations, who may benefit from treatment with Tagrisso.
Following this approval, we launched two versions of our Guardant360 test. Guardant360 CDx, the FDA-approved version of our assay, and Guardant360 LDT. The next-generation version of the assay, that offers additional biomarkers. We also announced three new CDx partnerships with Janssen, Amgen, and Radius Health. In recurrence monitoring, we initiated multiple studies. Which are aiming to establish clinical utility. For the detection of ctDNA, in the adjuvant setting in colon cancer. In early detection, we continue to make progress enrolling patients in our ECLIPSE study. Onboarding more than 150 enrollment sites, exceeding our target. And are on track, to complete enrollment in 2021. Looking at the fourth quarter, we ended with $78.3 million of revenue. Growing 25% over the fourth quarter of 2019. Clinical volumes for Guardant360 grew, to 17,353 tests. A 14% increase compared to the fourth quarter of 2019.
After the successful launch of Guardant360 CDx in September. We were encouraged by the acceleration of volume, and addition of new customers, that we saw in October. Unfortunately, the COVID resurgence adversely affected access to oncology accounts. With office closures approaching early pandemic levels. Towards the middle of November, and for all of December. Despite these extraordinary challenges, we are encouraged by the growth of not only Guardant360 test orders. But by the continued growth, in the total number of oncologists ordering our tests per quarter, another record number in Q4. We are confident, that outside of the impacts related to COVID. The fundamental drivers of adoption, for liquid biopsy remain intact. This belief is certainly bolstered by the strong recovery. We are seeing at the beginning of this quarter, from the lows in December.
Outside of the United States, we continue to make progress. And are investing in programs to expand global access, to our liquid biopsy program. We have partnered with one of the premier cancer centers in Spain, Vall d'Hebron Institute of Oncology. To help build a liquid biopsy lab, that will physically bring our technology to Europe. We have also achieved critical regulatory accreditations. Including CE marking for Guardant360 CDx, and important ISO certifications. In APAC, through our joint venture. We are also making excellent progress, in expanding our commercial reach. With testing now being provided in over 40 countries. I'm excited to announce, that we recently submitted our application for regulatory approval in Japan. And our new lab is expected, to be operational in Japan later this year.
Looking ahead in 2021, we expect revenues. To continue to increase over 2020. With accelerated growth, in the second half of the year. I believe, this will be a pivotal year for Guardant. As we continue to invest across our business, to build the foundations. For complete cancer testing, across the continuum of care. In our therapy selection business, we expect to continue to expand the utility of Guardant360. With additional approvals, clinical data, as well as broadening use of the test. In the molecular response, and monitoring settings. These developments will serve to grow, the total addressable market from $6 billion today. As these new applications of liquid biopsy take hold.
We are also very excited, for the upcoming launch of our first tissue product. Which we believe, will address the unmet need. That persists in the therapy selection market, due to the challenges. With many of the existing tissue offerings. In recurrence monitoring, we are breaking new ground. Just as we did with Guardant360 several years ago. Ushering in a new era of precision oncology, for earlier-stage patients. Through the launch of Guardant Reveal last week. This launch marks our formal commercial entry, into the estimated $15 billion opportunity. Of residual disease detection, and recurrence monitoring. That we believe will only grow as clinical, and pharma applications of this technology. Increasingly, become a new standard of care. In screening, we expect to complete enrollment of our ECLIPSE colorectal cancer screening trial. And expand into other cancer types. Addressing an estimated $50 billion screening opportunity.
We also significantly strengthened our balance sheet. With two capital raises during the year, ending 2020 with $2 billion in cash. With this capital, we are well positioned to aggressively invest in 2021, and beyond. Which will more firmly secure, and open up. A massive opportunity, to transform cancer care for millions of patients. With that, I will now turn the call over to AmirAli. For more detail on our biopharma business, and our pipeline activities.
Thanks, Helmy. Starting with our biopharma business, sample volume in the fourth quarter of 2020. Was 4,841 tests, 23% below the prior year period. Volume were up 58%, from the third quarter of 2020. Reflecting partial recovery from COVID, but more so the year-end rush for sample analysis. Development services, and other revenue grew 148% to $13.6 million. Reflecting our growing pipeline of CDx partnerships, and prospective studies. We are pleased with our progress. In pharma testing volumes, and growing CDx partnerships. However, in the first half of the year, we expect the impact of COVID to continue to be felt. With slower trial enrollment, delaying sample volumes. As well as CDx development services. We are seeing significant interest, in our companion diagnostic business. Following FDA approval of Guardant360, as a companion diagnostic for osimertinib.
We are pleased to announce, that we have submitted supplemental PMAs. For our collaboration with Janssen, with amivantamab, and with Amgen for sotorasib. The selection of Guardant360 CDx, as a frontline liquid biopsy device of choice. In these two programs demonstrates, the growing confidence of biopharma in our IVD offering. FDA granted priority review, or breakthrough therapy designation for these therapies. And we expect accelerated review by the agency. We believe liquid biopsy tests can add additional clinical benefit, to cancer patients beyond just treatment selection. We have over 40 publications, that demonstrate that a second liquid biopsy test. A few weeks after treatment initiation, can segment responders versus non-responders. Across multiple tumor types, and multiple classes of therapies.
These are exciting days for liquid biopsy, and it's clear that. As more of these tools become part of clinical practice. Such usage, will usher in even more applications. Many that we cannot even imagine today. Now, turning to our LUNAR program. As Helmy mentioned, last week, we were excited to announce the launch of Guardant Reveal. The first blood-only liquid biopsy test, for the detection of residual, and recurrent disease. With a simple blood draw, this test improves the management of early-stage colorectal cancer patients. By detecting ctDNA in blood after surgery, to identify patients with residual disease. Who may benefit most from adjuvant therapy, and by detecting recurrence months earlier. Guardant Reveal is in a class of its own, with industry-leading sensitivity and specificity. An average turnaround time of only seven days.
Compared to other tests, that require tissue biopsy. And also have turnaround times of four to eight weeks. CEA, which is the current standard of care. Has a sensitivity of 69%, with 64% specificity in the surveillance setting. Versus 91% sensitivity, with 100% specificity for Guardant Reveal. This level of performance has been achieved. Through analysis of over 400 KB of genome, spanning across thousands of regions. That may contain somatic mutation, or methylation signals from CRC. It is vital that oncologists have better tools, to quickly identify those high-risk patients. Who may benefit from escalation or de-escalation of treatment. The platform technology we use for our MRD test, is based on the integrated analysis of somatic genomic, and methylation changes. Which have potential for detecting tumor types. With high-level somatic mutations, or reach differential methylation patterns.
Besides CRC, we have exciting feasibility data in other cancer types like lung and bladder. Which gives us confidence, that our blood-only MRD tests. Will continue to have market-leading performance, as we expand Guardant Reveal . To multi-cancer types in the near future. Turning to ECLIPSE, we continued to see robust patient enrollment, throughout the fourth quarter. We have now over 150 sites, actively enrolling patients. Overall, we are pleased with our progress, and are on track to complete enrollment in 2021. If successful, ECLIPSE will play a pivotal role in regulatory approval. And reimbursement of our liquid biopsy screening test. We are starting to plan our next screening clinical trial. In other cancer types, and expect to share more updates about this, in the latter part of 2021. With that, I will turn the call over to Mike. For more detail on our financials. Mike?
Thanks, AmirAli. Total revenue for the fourth quarter of 2020 was $78.3 million, up 25% from $62.9 million in the prior quarter. This growth was driven by a year-over-year increase. In both precision oncology testing revenue, and development services, and other revenue. Total precision oncology testing revenue for the fourth quarter was $64.7 million. A growth of 13% compared to $57.4 million in the prior quarter. Precision oncology revenue, from clinical tests in the fourth quarter was $45.9 million. Up 47% from $31.3 million for the prior quarter. Fourth quarter clinical test volume was 17,353, up 14% from the prior quarter. The clinical test average selling price, was $2,642 in the fourth quarter of 2020. Up from $2,049 in the prior period.
The 29% increase in the clinical test ASP over the prior quarter. Was principally due, to expanded Medicare coverage of non-lung cancer tests. Which commenced in March 2020, and our success in gaining private pay coverage of our tests. Although clinical test volume, increased sequentially by 2% in the fourth quarter. Compared to the third quarter of 2020. Clinical test revenue of $45.9 million, decreased by $2.4 million. Compared to $48.3 million, in the third quarter of 2020. This was primarily due, to quarter-over-quarter fluctuations. In the revenue recognized from cash collected, for tests performed in the prior periods. Which in the fourth quarter of 2020, was $3 million lower, than in the third quarter of 2020.
Precision oncology revenue from biopharma testing, in the fourth quarter totaled $18.8 million. Down 28% from $26.2 million for the prior year quarter. But sequentially, up 57% from $12 million in the third quarter of 2020. Fourth quarter biopharma tests totaled 4,841, down 23% from the prior year quarter. Sequential test volume, was up 58% from the third quarter of 2020. Due to a partial recovery from COVID, and the usual year-end seasonality. Biopharma test ASP was $3,892, down slightly from $4,142 in the prior year period. Due to changes in the mix of tests performed. Development services, and other revenue in the fourth quarter totaled $13.6 million. Up 148% from the prior year quarter. Gross profit for the fourth quarter of 2020, was $49.9 million. Compared to a gross profit of $41.1 million, in the same period of the prior year.
Gross margin in the fourth quarter was 64%, compared to 65% during the fourth quarter of 2019. We expect our gross margins, to continue to be in the mid-60%s range. For the foreseeable future, as we launch new products, such as Guardant Reveal. Which will take time to gain reimbursement coverage from Medicare, and from private payers. Total operating expenses, for the fourth quarter of 2020 were $141.1 million. A 110% increase from $67.0 million, in the fourth quarter of 2019. This change was driven by an increase of $51.3 million, in stock-based compensation expense. Primarily related to market-based restricted stock units, granted to the company's founders in May 2020. As well as our continued investment in developing, and commercializing new products, and services. And in scaling our operations. In 2021, we expect stock-based compensation expense. To be between $170 million, and $180 million for the full year.
In addition, we expect operating expenses to accelerate in 2021. As we continue to invest in our LUNAR program, ECLIPSE study, and other development activities. As well as launch new products, and expand our commercial organization in both the U.S., and internationally. Net loss attributable to Guardant Health common stockholders, was $93.7 million or $0.94 per share, f or the fourth quarter of 2020. Compared to $25.2 million, or $0.27 per share in the fourth quarter of 2019. Adjusted EBITDA was a loss of $29.8 million, in the fourth quarter of 2020. Compared to a $17.1 million loss, in the fourth quarter of 2019. As a reminder, we define adjusted EBITDA. As net loss attributable to Guardant Health, adjusted for stock-based compensation, interest, income tax, depreciation, amortization. Other incremental expense, non-controlling interest, contingent consideration, and acquisition-related expenses. Turning now to the full year 2020.
Total revenue was $286.7 million, a 34% increase from $214.4 million in 2019. Precision oncology revenue increased 31% to $236.3 million. And was comprised of clinical testing revenue of $171.8 million. Which grew 70% year-over-year, and biopharma testing revenue of $64.5 million. Which declined 19% year-over-year. Despite the adverse impact of COVID, clinical test volumes for the year grew to 63,264. Up 27% year-over-year from 49,926 tests. The average revenue recognized, for clinical testing in 2020, rose 34% from the prior year. Primarily, as a result of the expanded Medicare coverage of non-lung cancer tests. Which commenced in March 2020, and our success in gaining private pay coverage of our tests. Clinical revenue for the year ending December 31, 2020. Also, included $11.9 million revenue, for payments from Medicare. From appeals for samples processed in prior years, compared to $6.8 million revenue in 2019.
The company does not expect to continue. To receive payments or record revenue, for these specific appeals in 2021. Biopharma testing volume, was also impacted by COVID in 2020. And despite a partial recovery in the fourth quarter. Declined 23% year-over-year to 15,983 tests. Development services, and other revenue grew 49% to $50.4 million in 2020. Reflecting our growing pipeline of CDx partnerships, and prospective studies. Net loss attributable to Guardant Health common stockholders, was $253.8 million compared to $75.7 million in 2019. Net loss per share was $2.60 in 2020, as compared to $8.04 in 2019. Adjusted EBITDA was a loss of $85.2 million in 2020, compared to a loss of $53.3 million in 2019. We ended 2020 with $2 billion in cash equivalents, and marketable securities. Now turning to our revenue outlook, for the full year 2021.
Despite the fact, that we are still in the midst of a global COVID pandemic. We view the fundamental drivers of our business. To be very strong, and as such, expect 2021 revenue. To be between $360 million, and $370 million. Representing growth of approximately 27%, over 2020 at the midpoint of the range. We expect clinical sample volume for 2021, to be greater than 90,000 tests. Which represents growth of at least 42% over 2020. Embedded in our outlook, are a few key assumptions around reimbursement. Firstly, we anticipate that the upcoming billing code change, to Guardant360 CDx in April . To an ADLT PLA code, may have a short-term impact on private payer reimbursement. Which could offset, any positive impact we receive. From an increased ADLT reimbursement rate from Medicare.
Secondly, although we are excited about, the launch of new tests such as Guardant Reveal. It will take time to receive Medicare coverage, and subsequent private payer coverage. As such, we do not expect the 2021 revenue, to be material for these new tests. As Helmy and AmirAli both mentioned, we are still experiencing COVID-related impacts. Across our clinical, and biopharma businesses. And we anticipate that these impacts, will continue in the first half of the year. Specifically, in the first quarter of 2021. We expect to see a reduction in biopharma volume, compared to the seasonally high fourth quarter of 2020. As I mentioned earlier, we do not expect to record revenue in 2021. From Medicare payers for samples processed in prior years. Which in the fourth quarter of 2020 totaled $4.6 million.
As a result of these factors, we expect revenue in the first quarter of 2021. To be sequentially lower, than in the fourth quarter of 2020. However, as we move beyond some of the COVID headwinds, and coding transitions in the first half of 2021. We expect revenue growth, to accelerate back above 30% by the end of the year. At this point, I would like to turn the call back, to Helmy for closing comments.
Thanks, Mike. Before closing, I want to again thank our team at Guardant. For the dedication, and effort they have shown. Particularly, over the past few quarters. I believe, that 2021 will be an unprecedented year for Guardant. As we are bringing to fruition the vision we had. When we founded the company, of significantly improving outcomes. Across the entire continuum of cancer care. This will be a pivotal year, in terms of the number of product launches. And the planned breadth, of our product portfolio. I'm confident that these product launches, will serve as drivers for strong growth in 2022, and beyond. These new products also mark, an important inflection point. As we begin to transform Guardant, from the leading liquid biopsy company. To the leading cancer testing company. With that, we'll now open it up to questions.
As a reminder, if you would like to ask a question. You will need to press star one on your telephone. That is star one on your telephone, if you wish to ask a question. Your first question comes from, the line of Brian Weinstein with William Blair.
Hey, guys. Thanks for taking the questions. A lot to get into here. We've heard a lot of companies this earnings season, talk about significant investments going into 2021. Given all of the new products, that are out there. I'm curious if you can talk about, the specific investments that you are making. I heard in the prepared comments, Mike had made some comments about OpEx going up. More specifically, can you talk about . Where those investments are going? And give us some idea specifically, around things like preparing for the CRC launch. Which is still a little bit of ways? But something that you have to start to be thinking about, or commercial efforts for the MRD assay. As you think about, scaling that up or anywhere else. I'm just curious, where you think the key areas are for investment this year?
Hey, Brian. This is Helmy again. Yeah, we're making investments across our organization. I'll start, and then maybe Mike fill in. Certainly, it's focused on our pipeline activities, and R&D. In terms of investing, certainly in these new products. The new trials that we have, and some R&D for new programs we have. Certainly, scaling up the commercial side of the organization. Obviously, these new products aren't going to sell themselves. We're expanding into other parts of oncology. Also starting to think about, as we race down the finish line of close. Really the commercial planning stages for that program.
Yeah. Maybe just to add, Brian, for us, it's a pivotal year of investment, as you mentioned. When we look at the operating expense, yeah. We think, that's going to ramp up as we make these investments. Something like an increase of $150 million-$180 million, increase over the year compared to 2020. Yeah, that's what we're looking at for this year coming.
Got it. Thank you. As it relates to Reveal, can you talk more about basis of competition here? How it may be different than other products? In oncology-based diagnostics, and if you think that having G360 already in the market? Clinically is something, that provides you any kind of clinical advantage, when talking to clinicians? Thanks.
Maybe have an early take.
Yeah, sure. We're actually just a couple of weeks, into this commercial activity around Guardant Reveal. But so far, I can tell you it's super good. We are excited, with the enthusiasm that we are seeing. Really many of our KOLs, and technology enthusiastic. And early adopters, that we are targeting at this stage. Are overlapping with the type of people, we interacted with for Guardant360. They have a pretty good respect, for the quality of the product and services. That they got from Guardant Health throughout the years. They are amazed, and actually very happy with the fact that. We are a blood-only test, that does not really depend on having access to tumor tissue. And also with pretty market-leading performance. While logistically it's much better, turnaround time is much better. It doesn't come at sacrifice of the clinical sensitivity, and specificity for their patients.
Really the way they are comparing us, with is with CEA as standard of care. That's the majority of conversation, that we are having with the doctors at this time. And the delta between Reveal, and CEA is very obvious. A performance of 64, 69 versus 9,100 is. I think, a very big delta that generates a lot of good excitement.
Your next question comes from, the line of Tycho Peterson from JP Morgan.
Hey, thanks. Similar line of questioning on the tissue launch. Just curious, A, what you think the market, was really missing between FoundationOne or some of the others? If you could confirm specific launch timelines? And how you're thinking about share capture, and then also the FDA approval pathway?
Yeah. No, thanks for the question. It's something we obviously have, thought about for some time. It was really a matter of when, not if. When we looked at the tissue space? I think we were still quite surprised, at how much of a challenge ordering these tissue tests continues to be? If you think about it, the end-to-end time. From a physician point of view, is three to four weeks. I know labs say they're 10 days, 14 days. But in terms of the tissue acquisition, actually getting the results back . Really takes three to four weeks, which is a non-starter. In terms of the time to treatment decision, and urgency the oncologist has in the frontline setting.
We realized that if we took the reins into our own hands of CGP, and really catalyzing the market. That if we develop our own tissue test. We could really integrate, that with our current offerings. And provide a user experience, a customer experience. That is completely differentiated, in terms of getting more markers faster, and quicker, and more completely. That's really the experience, that we expect to be able to provide to physicians. The way we think about it, is that in the base case. We'll be able to catalyze faster adoption, of a blood first paradigm in the market. I think in the bull case, we'll certainly be able. To take a considerable share, from some of the existing players.
Some of the challenges I think that exist, are that there's still a large percentage of patients. Over 50% of patients, that aren't genotyped comprehensively. And even more that aren't genotyped in the frontline setting, before the trigger is pulled for treatment. That's the challenge, and that's the unmet need. We think, we can squarely address with this tissue offering. We haven't released timelines at this point, in terms of the products, but stay tuned.
Okay. That's helpful. On G360, just curious how we should think about, the mix between G360, and the LDT?
Yes. I think you can imagine that both Guardant360 CDx, and Guardant360 LDT is going to have their own life cycle management. CDx most probably is going to get updated, as a IVD-grade device. And with less frequency than Guardant360 LDT, as a CLIA-grade device. Having the LDT in our portfolio, would really enable us to be nimble. And add newly upcoming biomarkers, on the clinical practice. Or on the pharma trial practice, actually faster into our offerings. CDx would be pulled through the revisions. With lower frequency, as I mentioned. Both of them are going to get upgraded, for the foreseeable future.
Last one, just curious, as we think about the ECLIPSE study. Kind of getting wrapped up later this year. Any comments you guys can make on follow-on studies for lung, breast, some other indications?
Yeah, sure. Actually, we are pretty excited about this topic. I think one was starting two years ago, when we talked about our ambitions around early cancer screening? Even before that, we talked about four cancer types, that at the time were constrained. CRC was one of them. The other one was lung cancer, breast cancer, and ovarian cancer. We've ensured, I think, some pilot data for some of the cancer types earlier. We made some progress for some of these cancer types. We believe the platform technology, that we have. That integrates the genomic biomarkers, with epigenomics, on the epigenomics side
Methylation plus all the structural changes, as a result of fragmentation pattern changes. It's super-duper powerful, to find cancers in various stages of disease. And we are happy with some of the feasibility data, that we've seen in other cancer types. That I think it's really the prime time, that after we really get ECLIPSE to. Hopefully, the last innings of it, we start talking. And doing some clinical trials, around other cancer types. The future of our LUNAR program, would be a multi-cancer screening program. CRC continues to be our lead indication in this marketplace.
Okay. That's helpful. Thank you.
Your next question comes from, the line of Doug Schenkel from Cowen.
Hey, good afternoon, guys. Thank you for taking my questions. I want to start with a high-level question, and then I want to come back. And talk about something specifically on Guardant Reveal. First, the high-level question. I think it's fair to say, that you guys established yourself as. Early on, one of the adults in the room. When it comes to, developing liquid biopsy tests in a responsible way? You quickly got a seat at the table early with the FDA, and CMS, and groups like AACR. This put you in a position, to not just launch G360. But to do it successfully with clinical, and regulatory rigor that resembles. What those of us, who grew up in biopharma? Saw there but didn't see often, in the early days of diagnostics.
That said, the market's getting more crowded, as menus from competitors. Seem to be evolving in a way, where it looks like there's going to be four to five companies down the line? That look quite similar, in terms of what they offer? What their menu looks like? I think that's going to happen, in the next four to five years, if not sooner. That's long been our view, but I think the pace, of moving towards that is accelerating. I mean, even you guys. It's come up a couple times on this call, launched a tissue product. The MRD product is coming to market a lot, more quickly than we anticipated.
My question is, how should we expect Guardant, to differentiate over the long term? When you, and four or five other companies? Have a menu that goes from multi-cancer, and single-cancer screening. To therapy selection in blood, and tissue to monitoring. What's going to differentiate Guardant, from others in the long term?
That's a great question, Doug. One that obviously we spend a lot of time, on thinking as a company. It's not just one dimension, that differentiates us. Even in therapy selection, when we launched. There were probably a couple of dozen companies, in the liquid biopsy space. On the surface, you could say that. There's always been competition, that there's always been a crowded field. In reality, it's really the quality, the level of performance of these products. The level of clinical evidence, that supports them. Really the customer service channel, the white glove service that we provide, billing and reimbursement. It really takes five or six different dimensions, to really change a standard of care. Change clinical practice in healthcare, as you all know.
We believe that we are second to none, in each one of those dimensions. Not just in therapy selection, but really taking that same approach. To these new products, that we are launching as well. We're actually, I think, pleasantly surprised by, how much differentiation still continues to exist? With 360 versus every other product, that has been launched that's out there. It's no different with Reveal. On the surface, you could say, "Oh, there's a bunch of companies working on MRD," but Reveal now is really the only. And what we believe, true liquid biopsy in the market that's tissue independent. That really has advantages of liquid. Without any disadvantages in terms of performance, and customer service, and customer experience.
If you think about it, we're the one company. That really does span that entire continuum of care, that has a very strong channel in oncology market. Over 9,000 oncologists have ordered our test. And that's probably a broad reimbursement, for products like Guardant360. We're, I think, very pleased at, how the market is shaping? The last thing I'll say, is that competition is important . Because it defines markets, it brings awareness to new products. And I think it really allows physicians to understand, and clients, and customers to understand. Really the use cases, and what good looks like? It's hard to really have differentiation. In terms of the performance of our products, and the performance of our services. Without a backdrop to compare it to.
Thanks for all that. That's helpful and interesting. Now for the Reveal specific question. In your recent presentations, and press release. I think you indicated that Reveal has a sensitivity of 91%. You talked about that, in your prepared remarks today as well. I believe this improvement, is at least in part attributable to the fact . That on top of methylation markers, you've now added genomic alteration assessment to the assay. I may be oversimplifying or maybe misstating this, but assuming I'm going down the right path. I'm just wondering, if the addition of these additional markers. Which seemed to be important, to improving performance? Have led to any other compromises, as part of the assay. Specifically, I'd love to just hear. If you think you need to, basically require a larger sample size? To accommodate the additional markers on this assay.
Probably, a more simple question, I know it's early. I believe that most would assert, that there is an inherent advantage. To using a non-bespoke test, versus a tumor-informed test. If there are not other compromises required. I know that's your belief. Are you hearing anything in terms of early market reaction or market research, that is consistent with that view? Thank you.
Thanks, Doug. Regarding the core platform technology for Reveal. Maybe starting with that 91% sensitivity, that I mentioned in script. Actually, that's the sensitivity in the surveillance, when you're trying to detect early relapse. Which is the biometric of actually the operation in CRC setting. Now, this is the exact same assay, that we are using in our clinical trials for COBRA, and Stand Up To Cancer. In fact, except some process improvement happened, for scalability of this device. For potential huge uptake, of this device in the years to come. Some of the process, and operational infrastructure has improved for device. But the assay, and in fact, the performance is very similar to what we are doing. Our interventional studies, COBRA, Stand Up To Cancer, and other studies.
Yeah, the core platform is based on combining, and integrating multimodal information. From the same cell-free DNA fragment. Which in this case, we are combining somatic mutation, and methylations in MRD setting. Reactions of KOLs, and the target list that we have. Still, as I mentioned, it's early. To be in the very second recap of this commercial launch. All the conversation so far, has been very positive. And I think this is really resonating, with customers that we talked to so far. That a blood-only assay, can really help their practice tremendously. Really, they are comparing the performances, with other blood-only standard of care assay, like CEA. They are saying that the performance, and the promise. There is a big delta in terms of performance, and promise here. And that generates a lot of excitement.
Having said that, we think it's going to take some time for adoption of this test. Multiple conversation needs to happen, in order for this test to get adopted. But we are super pleased, with the early reaction of the market. To what we put out there.
Thank you for that. Just one thing, I may have missed in that answer. In terms of the sample size requirement, nothing different with the current version. Recognizing that it's pretty consistent with, what you're doing as part of that other study?
Yeah, it is the same actually, the number of blood tubes. If you mean in terms of sample types, it is the same number of blood tubes. That we are getting for our clinical trials. It is exactly the same. We made it more scalable on some of the infrastructure, and operation aspects of it. So, the device is the same device. Yeah, just because of the genomic panel things, because then we need to input a question.
Okay. All right. Thank you very much.
The next question comes from, the line of Puneet Souda from SVB Leerink.
All right, great. Thanks, Helmy and AmirAli. First question I have is on guidance. You're projecting 90,000 in terms of test volumes here, which feels pretty robust? The revenue growth for the full year, is coming in slightly lower, than what we had anticipated? I just want to hear, and you're pointing out biopharma volume reduction in the first quarter. And Medicare appeals also not being included, so I completely hear you on that. But just wondering, maybe could you give us a view of? Where you stand in terms of the demand, that's coming through for biopharma services, OMNI, G360 currently? And what is the demand outlook, from biopharma throughout the year? As I view it, not only you'll see demand from those products. But you also see demand, from the recurrence monitoring product. And potentially some other products, that you could potentially launch.
Just want to get a sense on, how should we view the biopharma growth?
Well, in my case, it's Yeah, Puneet. I think, when we look at the biopharma growth. We think that's going to be strong. We think it'll be low double-digit growth, so carrying on that sort of robust performance. I think, you mentioned that a bit of a difference. Even though we talk about strong clinical volume. Maybe a bit of a difference, from the numbers that you had. And I think the main driver there is on the clinical ASP.
We saw the ASP being around, $2,600 in the fourth quarter. That's probably likely, to be the ASP throughout 2021. I laid out some assumptions on reimbursements around new products. Not expecting reimbursement for those, and non-material revenue for those. Also, potentially the issues with private payers. As we switch CDx to an ADLT PLA code. I think, really the discrepancy is not coming from biopharma volume. Which again, we think is strong. It's more on the ASP assumptions than other.
Okay. That's very helpful. On the ECLIPSE study, Helmy, it appears the enrollment is progressing well. I'm wondering, if we should expect anything? Any other data sets that were smaller cohorts, and whatnot. And maybe AACR, you have DDW coming up as well, and as ASCO. Could you maybe just elaborate potential for any data sets, smaller data sets there? Again, if you could just maybe clarify on the timing, of the readout here for ECLIPSE? Because I think, that's highly anticipated among investors.
Go to AmirAli.
Yeah, sure. In terms of the upcoming data, if you could imagine like many major congresses. We are going to continue, to provide some additional data. In fact, our collaborators, are going to contribute a lot of data. We gave access to our device, to a bunch of collaborators. To assess the performance, of our screening assay in different cohorts. Having said that, all those cohorts is kind of in a biobank setting. There are similarities between the type of data, we showed before versus what is going to get presented? I think so far, all the data are positive, and more to come in different congresses. In terms of the data set similar, to what we expect from ECLIPSE? Which is prospective screening of 10,000 patients? We are not going to have such data, till we really get it from ECLIPSE.
We need to be still patient, for that study to finish.
Okay. Yeah, go ahead.
Could you repeat the second part of your question? I missed it.
Yeah, it was just in terms of the timeline for ECLIPSE. And given the growth, the robust enrollment that you're seeing here.
Yeah. So far actually, we are expecting that the study. Would finish by the timeline, that we always mentioned. Through COVID, we had ups and downs. But overall, I think we are on track to finish this study on the timelines, as we always mentioned. So far so good. We'll see how it continues during, the remainder of the next few months.
Okay, great. Last one, if I could squeeze in on MRD, and recurrence monitoring. Obviously, you have had data here in CRC. But when we look at, another competitor in space. There are slightly more publications, more data sets that have come out. Obviously, Guardant is focused on building strong clinical evidence. For its products, and is usually the first one to do so. Maybe just if you could elaborate for us, the efforts that you are doing on recurrence monitoring. The CRC, and maybe indications beyond that in IO or lung or breast. That could potentially yield further data sets, and clinical evidence. That helps physicians, look at the assay more closely. Thank you.
Absolutely. There are several ISRs, that actually are finished. There are several other ones, which are ongoing. And we have a manuscript that the data, that we are talking about. In terms of performance of a reveal is, coming from a collaboration. With one of our major partners, major cancer centers in the United States. There is a manuscript under review, that hopefully basically will get published soon.
Your next question comes, from the line of Tejas Savant from Morgan Stanley.
Hey, guys. Good evening. Thanks for the time here. Helmy and AmirAli, on the tissue biopsy launch. Helmy, you've spoken a couple of times, about sort of the importance of reducing the turnaround time there. Versus the entrenched sort of tissue biopsy competitors. How much shorter do you think, that turnaround time can be? Particularly, given the fact that a lot of times. It's the pathologist, who takes some time to draw the sample, and send it off to the lab? How exactly do you plan to sort of compress that timeline, relative to some of the other competition out there?
That's a great question. I think, I would just refer you to our liquid biopsy test. We're averaging about five days in average, in terms of turnaround time. If you look at a lot of other liquid biopsies out there. They're 10- 14 days, sometimes even longer. That's not even taking, into account pathology time or getting tissue access. There's certainly, I think, a level of automation, and operational excellence. That we have in our organization that.
Doesn't seem to be matched, with other products that are out there. Clearly there's a lot of know-how, that we can confer. And apply to the tissue side of the process. We're very confident, that it's not just about the tissue product on its own. It's also about how all these products work together? A liquid product, a tissue product. And I think in having that sort of integrated offering. We can provide a customer experience. Which is more aligned, with what oncologists want to see? Which is making sure, they get everything they can. In terms of biomarkers tested in their patients, as quickly as possible, and not missing anything. We think we'll be able to provide that experience. That is at a level, that really hasn't been seen in this field to date.
Got it. That's helpful. One quick follow-up for Mike. Just in terms of the guide here, what are you including for OUS expansion? Obviously, you've got the Vall d'Hebron partnership you announced, and the Japan expansion as well. OUS, and then on the development services front. Obviously, sort of an uptick in 2020 there. How much of a normalization, should we expect in that line item in 2021?
Well, on the OUS, of course, we're not breaking out those numbers. We think that's a great opportunity for us, and probably an opportunity. For upside throughout the year, as to how that goes in both Europe, and in Asia. On the development services side, we've seen it strong over the last three quarters, actually. I think that will continue through the year, and then we're bullish about. The development services revenue throughout 2021.
All right. Thanks so much, guys.
Your next question comes from, the line of Derik De Bruin from Bank of America.
Hey. Thanks for squeezing me in. Just a follow-up on ECLIPSE. Could you just sort of outline a little bit more? Once you sort of get the readout, the potential for commercialization. Just your general thoughts on LDT versus inclusion, and guidelines. This is an area we've kept getting a lot of input on from investors. Just basically wanting to understand, what your approach is? And do you need to go out, and build a sales force. And is that sort of inbuilt into your plan? Just a little bit more, on your commercialization efforts on Eclipse would be really helpful. That's my only question. Thanks.
Sorry, I'm going to steal this, [audio distortion]. I think I started in November of 2019, which is going to take about 24 months. That's what the timeline for enrollment will be. It'll take another little bit of time, to process the samples. And get the data collated, and then get that submitted to the FDA. In the meantime, clearly, we're very optimistic about the performance. We've released data already in other cohorts. Where we have, what we believe is performance that will meet the standards, and the minimum thresholds. That have been outlined in the NCD for Medicare coverage. I think we're cautiously optimistic that ECLIPSE, will be able to read out, w ell above those targets. In the meantime, we are laying out the foundations. For a commercial channel in the primary care space.
That's clearly a very large segment, with 200,000 primary care physicians. That's going to take a considerable investment, and we are certainly. In the early stages of laying that out, and building out the team. So that as soon as the data reads out, we're ready to go.
Your next question comes from, the line of Patrick Donnelly with Citi.
Great. Thanks, guys. Helmy, maybe one for you just on the guidance. Certainly, appreciate that your guys' volumes weren't pressured nearly, as much as other diagnostic tests during COVID. The recovery is not going to be quite as sharp. Can you just talk through? I guess, the impact you saw, as we went through 4Q. And then the level of conservatism, that's kind of baked in here. As we think about the trajectory, as we go through 2021. In terms of patients coming back. Again, obviously, the impact wasn't quite as significant given your patient set. Just curious in terms of, how you factor that in the volume guide?
No, I can start, and then Mike can touch in. Yeah, Q4 was interesting. Obviously, we were just coming off the heels of our launch. With our CDx, and our LDT. And we really saw a nice acceleration, in terms of the number of physicians ordering a test. The volume that we were seeing, in terms of both of those tests. It's very encouraging. As you know, I think the resurgence of COVID was probably greater than most. Had really anticipated, at that time or before that time. And really caused, a significant impact in terms of office closures. Well below 20% in terms of in-person visits. Really similar to the height of the pandemic in April, and May in terms of access. It's a very challenging environment to be able to sell there.
Despite that, we saw a very nice. I think, year-over-year growth in Q4. I think, it's really a testament to both the, I think, differentiation of the products. As well as really the resilience of the Guardant team as well. As the resilience of these clinician offices, that have learned to. I think, deal with patient care in this new environment. I think based on the numbers we have for 2021. I think we have considerable growth there, in terms of clinical volume with 90,000 tests over 2020. I think we are very bullish, in terms of really continued adoption of this testing.
I think the challenge is that, it's certainly going to continue in the first half of the year. We expect, as we're seeing COVID cases decline. And hopefully, they continue to do so over the next couple of quarters. That we're likely to see further acceleration, in growth in the back half of the year.
Yeah, maybe Helmy needs just to add, but I think you said it all. But really, baked into our assumption is COVID. Of course, everything's vaccine dependent on, how that can roll out? We built into the numbers really a COVID impact, in the first half of the year. And then making an assumption, that in the second half of the year, that's sort of alleviated. That's how we're looking at the year, and that's really baked into our numbers. As Helmy said, we still think if we achieve 90,000 clinical tests in this year. Then it'll be a very strong growth.
That's helpful, guys. Appreciate it.
Your next question comes from, the line of Dan Arias from Stifel.
Yeah. Hi, guys. Thanks for getting me in here. Helmy, maybe just one for me on Reveal. Obviously, you guys are looking to get settled here in colorectal cancer first. But just to the point on usage in a broader setting. I'm just curious, where you are in terms of your thinking about? How quickly clinicians might look to translate? Confidence in one tumor type, to usage in another. In other words, if you build on the ESMO data, and if COBRA reads out positively. Can that sort of be a gateway, to adoption in other cancers? Or do you think that you kind of have, to prove things out tumor type by tumor type?
I think we can take parallels from, what we did with Guardant360? In terms of really , almost singularly focusing on lung initially. What we found, was that by using a compass. That leads us in the direction of maximum clinical utility. That really maximizes, the positive reaction of the user experience. As these products find utility, impact decision-making in one cancer type. Given that many physicians are generalists, and they're seeing many other cancer types. We found that translates into positive perceptions. And, I think perceived clinical utility, in other cancer types as well. Ever since we've had strong traction in lung cancer. We've seen growth in other cancer types, that has continued to track, the growth that we've had in lung. That being said, as we prove out specific cases for utility in other cancer types. Those can be added drivers, for those specific indications.
We've seen that with G360, when we have drug approvals in breast cancer or in prostate, and so on. We've seen considerable step function, increases in volume for those specific indications. We believe that it'll be no different, for this product regarding Reveal.
Okay. Thank you.
Your next question comes from, the line of Max Masucci from Canaccord Genuity.
Hey, thanks for squeezing me in. In the prepared remarks, you spoke about the 65% decline, of new diagnoses of cancer in 2020. Unfortunately, some of these patients may never have the chance. To receive a Guardant360 test, but I'd imagine that for those that do. They'll be diagnosed at a later stage. How are you thinking, about this playing out in 2021? Probably more in the second half? Is this something that you can act upon proactively, and forecast in 2021 or not so much? Thanks.
Yeah, I think it's difficult to assess exactly, how much of a backlog effect, or bolus that would create. Just given the different timescales, and so on in terms of diagnoses. To metastatic disease, and different disease states. That said, we see that so many patients, still are not comprehensively genotyped. That I think there's still a lot of room, to grow even outside of that backlog. Whether it persists or not. I think that's why, I think we're very bullish in terms of continued volume increase. In terms of Guardant360, as well as potential other products down the line. We're still very much in the early innings, of adoption of these types of tests.
Great. Thank you.
There are no further questions at this time. I would like to thank everybody for joining. This concludes today's conference call. You may now disconnect.