Earnings Labs

Guardant Health, Inc. (GH)

Q3 2023 Earnings Call· Mon, Nov 6, 2023

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Transcript

Operator

Operator

Hello, everyone, and welcome to the Guardant Health Q3 2023 Earnings Call. My name is Thrisha, and I'll be your operator today. [Operator Instructions] I will now hand you over to your host Carrie Mendivil, Investor Relations from Guardant Health. Please go ahead, Carrie.

Carrie Mendivil

Analyst

Thank you. Earlier today Guardant Health released financial results for the quarter ended September 30, 2023. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO, and AmirAli Talasaz, Co-CEO and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties as well as the reconciliation to the most directly comparable GAAP financial measures are available in the press release Guardant issued today as well as in our Form 10-K and other filings with the SEC. Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements whether of new information, future events or otherwise. The information in this conference call is accurate only as of the live broadcast. With that, I'd like to turn the call over to Helmy.

Helmy Eltoukhy

Analyst

Thanks, Carrie. Good afternoon and thank you for joining our third quarter 2023 earnings call. I will start off our call today with our top-line results for the third quarter and then go into more detail on our progress in therapy selection and MRD. I will then turn the call over to AmirAli for an update on screening. And finally, Mike will provide a more detailed look at our financials and outlook for the remainder of 2023. Starting on Slide 3. Guardant is a liquid biopsy leader in therapy selection with a strong pipeline of opportunities in MRD and screening. With our comprehensive suite of tests we are transforming patient lives across the continuum of care. In early September, we hosted our inaugural Investor Day where we shared our long-term vision for Guardant. I encourage anyone who wasn't able to attend our Investor Day to access the replay on the Investors section of our website. It was a great opportunity to reflect on how far we've come over the past decade and look ahead to where we are going. We are just scratching the surface of what we believe is a massive opportunity in front of us. Our commitment to patients has always been at the heart of what we do. We look forward to continuing to grow our reach to impact more patient lives across the globe. To demonstrate the impact of our tests, I will start our call off today by sharing patient story for our newest product, Shield. Earlier this year a woman in her late 50s visited her primary care physician. She was un-screened for colorectal cancer and was resistant to receiving a colonoscopy. Her physician proposed a Shield LDT test which was added to our annual blood work. The Shield test results reflected an abnormality…

AmirAli Talasaz

Analyst

Thanks, Helmy. Turning to Slide 9. We are continuing to make advancements with our Shield blood test as we pioneer a new category in the CRC screening market. We submitted our premarket approval application for Shield last March and are making steady progress with FDA review. We continue to expect FDA approval and the launch of Shield IVD in 2024. Most recently we concluded enrollment in our ECLIPSE clinical study. Collectively we enrolled over 45,000 patients and biobank these samples. This is a huge milestone and this biobank will really be a treasure for us for additional regulatory grade studies for future device upgrades. Turning to Slide 10. We are committed to innovation and continuous improvement cycles powered by efficient data generation. At our Investor Day in September, I shared some exciting new clinical data for the next-generation version of Shield. This data looks at the U.S.-based colonoscopy screening cohort of about 2,000 blinded cases collected prospectively from clinical sites and included screening negative adenomas and CRCs. Individuals from this cohort were tested with both version of the Shield tests. The version used in our PMA ECLIPSE study which we will refer to as the Shield V1 and the next generation version, which we will refer to as Shield V2. When we look at Shield V1 performance in this prospective cohort sensitivity was 84% with specificity of 90%. This was in line with the performance we saw from the same as an ECLIPSE cohort where sensitivity was 83% and specificity was 90%. With the upgraded algorithm in V2 overall performance improved to 91% sensitivity and 91% specificity in this new perspective cohort. Looking at only early-Stage 1 or 2, sensitivity was 88% compared to 76% using the V1 assay. CRC sensitivity in Stage 3 and 4 with blood test for…

Michael Bell

Analyst

Thanks, AmirAli. Starting with Guardant360 ASP on Slide 12. As Helmy outlined, we're starting to see the positive impact on Guardant360 ASP from commercial payer coverage wins that have recently received confirmed and proposed Medicare price increases to Guardant360 LDT. In the third quarter the Guardant360 ASP again trending towards the upper end of the $2650 to $2,700 range we saw in Q2. At the start of October, we were informed by MolDX the Medicare price for Guardant360 LDT has been increased from 3,500 to a new GAAP full rate of $3967 effective October 1, 2023. Furthermore, in late September, CMS published its preliminary Clinical Lab Fee Schedule for 2024 which proposed that the Guardant360 LDT price crosswalk Guardant360 CDx. This proposal is finalized Medicare price for Guardant360 LDT will increase to $5,000 as of January 1, 2024. To put this price increase into context. Medicare Guardant 360 LDT tests, represent between 10% to 15% of our total Guardant360 volume. As a result, the impact of the Medicare price changes will be to increase the overall Guardant360 ASP to be between $2700 and $2750 in Q4 2023. And then the CMS proposed crosswalk pricing is implemented $2,850 to $2,900 from January 1, 2024. With the tailwinds we're seeing on coverage and pricing. We are making very good progress towards the goal we stated at our recent Investor Day of ultimately realizing an ASP of over $3,000 for Guardant360. Now turning to our Q3 financial results on Slide 13. Total revenue for the third quarter of 2023 grew 22% to $143.0 million compared to $117.4 million in the prior year quarter. Total precision oncology testing revenue for the third quarter was $133.4 million, increasing 31% compared to $102.1 million in the prior year quarter. As in previous quarters. This increase was…

Operator

Operator

[Operator Instructions] The first question we have comes from Tejas Savant from Morgan Stanley. Please go ahead.

Tejas Savant

Analyst

Hi guys, good evening, and thanks for the time here. Helmy Mike thanks for the color on the GD360 ASP. Just had a couple of quick follow-ups, as my opener. Where do you anticipate that LDT versus CDx mix settling out following the change and how should we think about the impact of the unique CPT code on the private payer side of things.

Michael Bell

Analyst

Yes, hi, Savant. I can take that. Yes what we've seen over the past 12 to 18 months is slowly the waiting between LDT and CDx has sort of moved more towards the CDx. So it's, I think it's fair to say that it's just over 50% on the CDx side. And so, we're not really anticipating that this change in pricing is really going to change that mix. What we've seen really driving the change in mix is the CDx approval is that we've been getting over the last 18 months or longer. So, I don't think the price impact will change will change that much. I'm sorry. Then the second part of the question Tejas on the unique code.

Tejas Savant

Analyst

That was just on the private payer side of things.

Michael Bell

Analyst

Now I think we think that's also be a positive. What we've sort of talked about with that increase in ASP is purely the Medicare impact. And so I think there's potential additional improvements to the ASP, one from Medicare Advantage. And so, we think that will definitely help. But yes, having a unique CPT code, it's going to make the processing simpler for the private payers. They'll have a Medicare list price to match against what they're paying as well. And so we think potentially, it could make the system. Well, take some friction out of the system, make the pricing more transparent than could have a positive impact. So, we've not baked that into our ASP projections yet, so we'll see how that goes next year.

Tejas Savant

Analyst

Got it. And then one quick follow-up on PEGASUS. Helmy, can you help us contextualize the significance of that readout for us? It sounds like of that -- so 10% of patients who experienced a relapse in the study, is that level sufficiently low enough to get physicians comfortable with de-escalation following a negative MRD result just based upon your physician conversations so far. And given that this was the older version of the assay, how do we read through the results to the commercially available version?

Helmy Eltoukhy

Analyst

Yes. No. So I think this is very positive in multiple aspects. The fact that this potentially highlights that you can spare patients these high toxicity as adjuvant chemotherapies. And this is really a sort of target that the investigator said that they felt would move the standard of care for those patients forward. And the fact that we met the sort of interim endpoints and I think is really exciting. And so I think we're really looking forward to the full readout of this trial sometime in 2024. In terms of how this reads through to current version of Reveal and future versions, we see essentially improvements across the board in terms of sensitivity and specificity. And so clearly, if you're using an even better assay than when you are the results should be even better. So, we think this bodes very well in terms of being able to translate these results to our future versions of assay.

Operator

Operator

Thank you. We will take our next question from Dan Arias from Stifel. Please go ahead.

Dan Arias

Analyst

Here we go. Thanks for the question Mike, on just the clinical volumes for the quarter and for the year, 44,000 or so for the quarter, which I think is up about 1% sequentially. Do you still think you finished the year with high 30s or low 40s growth as a target for 2023? That does imply a step-up in 4Q. So just checking to see what the right way to model the full year is?

Michael Bell

Analyst

Yes, Dan. I think year-to-date, we're still over 40% year-over-year on clinical volume growth. And yes, for the full year, yes, high 30s is sort of what the guidance implies. So yes, we're still very confident that we'll see a sequential uplift in Q4 and very strong year-over-year for the full year.

Dan Arias

Analyst

Okay. And then AmirAli, on Shield, as we close in on the end of the year here, wondering if you just -- you might be willing to dial in your working assumption on a commercial launch time for 2024. And then just kind of expanding on some of your comments that you made at the Investor Day. It sounds like the USPSTF data review process could start next year for parts of the process anyway. Can you just add some color to the thought around having the likelihood of V2 get a look from the USPSTF as a part of that cycle? And then what that might mean if that doesn't happen and you have V1 being considered by the USPSTF, but V2 being the assay that presumably you feel better about going to market with?

AmirAli Talasaz

Analyst

Yes, sure. So in terms of the review cycle, as I mentioned in the prepared remarks, we continue to see good progress, steady progress in the review cycle and continue to expect approval and launch of Shield IVD in 2024. Regarding the cycles for USPSTF Yes, for 26 guideline inclusion, typically, they start the data review a couple of years before. We expect that review start sometime in the middle of '24 to second half of '24 and then conclude with a recommendation updates in 2026. Regarding Shield V1 and V2 guideline inclusion, I continue to believe Shield. We won with the performances that we reported as long as we can get FDA approval for it, that hopefully, we would get into the guidelines. And once Shield as a blood-based colorectal cancer screening branded by Shield goes into guidelines, future upgrades and updates to that test it's going to continued market as Shield. So I don't believe that we need to go through the cycle of USPSTF in order to get the benefit of the commercial payer coverage that Shield would have. So once the Shield V1 goes through that process, all the future versions as long as they are better than Shield, I expect them to be grandfathered in similar to what we experienced with other products that we upgraded them and the coverage policies continue to stay in place.

Operator

Operator

The next question comes from Mark Massaro from BTIG. Please go ahead.

Mark Massaro

Analyst

Hi guys. Congrats on a strong quarter. I guess the first one is for Helmy. It's encouraging to see Geisinger and Blue Cross Blue Shield Louisiana come on for a Reveal MRD. I'm curious what other types of conversations are you having with other payers? I know that MRD is not yet included in NCCN guidelines. So I'd be curious to hear your thoughts on when you think MRD testing can be included in NCCN guidelines and how those conversations with other payers are trending at this time?

Helmy Eltoukhy

Analyst

Yes. Great question. Mark. I would say that, obviously, with 360 CDx, we have over 300 million covered lives. And so we have a very strong managed care team that has relationships with many of the plans out there. And so, I think those conversations are ongoing. We're continuing to make very good progress, I think, with many plans. And I would say that the state biomarker bills are certainly tailwind catalyst in terms of getting us to coverage sooner rather than later. I think that's why I highlighted that now over half of the U.S. population is covered in a state that has one of these biomarker bills, and we obviously have New York and Ohio and hopefully some other states down the pipe. And so, we see this as a very important structural change in terms of how cancer tests are reimbursed that if you have Medicare and you have the state biomarker bills, you actually have a really nice light path in many states towards full coverage, which is really going to upend what we think about cancer diagnostics in the entire industry for years to come. So this is a very big move. And one that bodes well for MRD and potentially for other tests that we bring to market in the cancer biomarker testing space. NCCN guidelines, I think utility data is what's typically required. I think PEGASUS will be a sort of positive piece of evidence that further bolsters the case for MRD testing. But there may need to be some additional readouts from the clinical utility perspective before we see guidelines change.

Mark Massaro

Analyst

Excellent. And then my second question, the clinical volume growth of 35% was strong in the quarter. Is there any way you could break out the volume growth from either TissueNext or Reveal and then as we're thinking about 2024, I would love to get your latest thoughts on to what extent the integration with the EMR providers can help accelerate ordering either from 360 reveal or other tests?

Helmy Eltoukhy

Analyst

Let me start with the second half. The first one, this is typically a huge uplift when you are able to integrate digitally with providers in terms of how they practice medicine and how they order their battery of tests and procedures and being able to really go a long way this year and hopefully next year in terms of integrating with most of the U.S. oncology market. We think is going to be an additional growth driver. We're doing things at the large group practice level, account levels, as we said, we'll have over 400 accounts integrated this year. And so, there's going to be a lot of top-down work that we're embarking on, especially in the community type centers that we think will allow us to essentially embark on the next stage of growth, not just for the 360, but for all our oncology products.

Michael Bell

Analyst

Yes. And on the volumes without breaking down into specific numbers, but both Reveal and TissueNext next year-over-year growth were both very strong. I think in previous quarters, like in previous quarter, Q2, both were year-over-year growth was over 100%. maybe both a bit slightly lower than the 100% year-over-year growth in Q3. But year-to-date Reveal is still well over 100% year-over-year growth. TissueNext very close to of 2% year-over-year. So good in the quarter, a very strong year-to-date. So again, I think we're looking at closing the year out strong on both Reveal and TissueNext.

Operator

Operator

Our next question comes from Puneet Souda from Leerink Partners. Please go ahead.

Puneet Souda

Analyst

Maybe just on Shield V2. Can you just confirm if the biobank samples that you have are untouched and sort of unutilized in any of the trials so far that you can actually use them in the pivotal trial for the Shield V2 and get that submitted. Maybe just a clarification there first, and then I have a follow-up?

AmirAli Talasaz

Analyst

Yes. So the short answer is yes. More details, we have enrolled about 45,000 about 24,000 of them have been used in the first study through the CRCs that we analyze from that first 24,000, and we have 20,000 plus more patient on touch blinded - CRC's on touch blinded asset in almost the same in our biobank.

Puneet Souda

Analyst

Got it. Okay. And then just maybe one quick follow-up for you, AmirAli. I mean anything -- any feedback from FDA, you pointed that the conversation is going well there, but I just wanted to see if there are any updates on that front. You pointed out about 2024 approvals still. Just wanted to get a sense of if you have any sort of guidepost in terms of earlier versus later or sort of first half versus first quarter. Anything you can provide there would be super helpful?

AmirAli Talasaz

Analyst

Yes. As I mentioned it, we are continuing to make steady progress. Still we are under review. We are not done with it. And it's very hard to predict the exact timing of it. But the confidence level is very, very high. That would be in 2024, as we expected at the time that we submitted the PMA, so continues to be the same. And the agency have been very collaborative with very collegial kind of attitude toward our application. They understand value of blood-based cancer screening, colorectal cancer screening. So we are pleased with the review cycle so far. We see how it goes.

Operator

Operator

Thank you. Our next question comes from Kyle Mikson from Canaccord Genuity. Please go ahead.

Kyle Mikson

Analyst

Perfect. Hi guys. Thanks for taking the questions. My question for you, Mike. Given this G360 ASP trend benefiting from the multiple tailwinds with Medicare pricing, could you maybe just estimate, I guess, tell us if it's possible that G360 ASP could increase to some level by the end of '24. Look at the average revenue per test approach, maybe like 300 by that point. And then also, Mike, just a question on like cash flow as we think about getting to breakeven by the end of this year and then kind of going forward, how dilutive to cash flow generation is MRD and reveal like right now, in other words, how much of an investment there to advance that strategy like given that return so for that kind of mid-teens revenue number?

Michael Bell

Analyst

Yes. Kyle, on Guardant360 ASPs. Yes, I mean we've seen really good traction, both on the Medicare side. We have to wait for the finalization of clinical lab fee schedule yet. But if that comes through, we'll be closing down on 2,900 at the start of next year. And as I just mentioned on the call earlier, there are potential other tailwinds, we could see Medicare Advantage come through. We could see that also helped with private payer payments for Guardant360 LDT. So I think we've seen good traction. We set out on our Investor Day, it was 8 weeks ago then we wanted to get to a target of 3,000. So I think at the moment, we're feeling very confident we can get we get north of 3,000. Definitely in the five-year time line we said on the Investor Day, but I think probably we're trending towards that a little bit earlier than we would have anticipated and exactly where we can go. I think we'll have to see how these tailwinds roll out. But again, we're confident. And then on MRD. I think we've broken it out before, probably the net investment on the MRD, if you take into account the cost of processing the test this year the research and development efforts that are going into it and the data development efforts as well as the sales and marketing costs, probably a net investment of around $100 million this year, give or take. And we see that likely continuing into at least 2024. Of course, the key for us, and we're managing the volumes to try and stay manage the cash burn and yes, the key for us going forward is really to get additional reimbursement. And we've talked about CRC surveillance and then other indications. So that's what we're really focused on with and at the same time, managing the burn.

Kyle Mikson

Analyst

Okay. That was fantastic. Mike, thanks so much for that. And then AmirAli one on screening for you. The approval seems pretty likely. I think you mentioned like mid-24% around there for Shield. What's the latest thinking there for you on the label that you ultimately attain, like second-line, third-line test. Just wondering if you discussed that with the FDA at all or maybe that's included in the -- in your opinion in this PMA submission?

AmirAli Talasaz

Analyst

Yes, just to clarify, I think the mid-'24 time line that I mentioned was connected to the potential time that USPSTF review cycle in terms of some of the early data research would start based on our understanding of the process. In terms of label, we haven't got to the label negotiation yet so far, there's been some conversation with agency about this matter. And I think so far, so good, but we'll see when we go to the official like label negotiation phase what happens.

Operator

Operator

Thank you. We will move on to the next questioner, Jack Meehan from Nephron Research. Please go ahead.

Jack Meehan

Analyst

Thank you. Good afternoon. For Helmy. A couple of questions on the G360 volumes. First is with breast cancer. This dynamic you called out. I was curious, do you think this sequentially continues to taper in 4Q? Or is that bolus normalized at this point? And second, volumes are obviously pretty strong. I was just curious with the dynamic backdrop we're seeing, are you seeing any changes in market share versus tissue or other liquid players? Thanks.

Helmy Eltoukhy

Analyst

Yes. No. As I said, there was a sort of warehousing effect that happened where you had this pent-up demand for everyone that wanted to get on the drug. And so we had a huge jump up and we believe we've completely worked through that bolus. And now we're just continuing on a very nice trajectory. And I want to highlight that we're still extremely elevated levels of breast cancer testing than we were a year ago. I think year-over-year, we're over 100% growth. And so we're very excited in terms of where we are with breast cancer. And I think now on kind of the right trajectory here, now that we've worked our way through that bolus. Yes, in terms of sort of competition, I think we're seeing a lot of the kind of same dynamics play out, ebbs and flows, the usual suspects out there. But we continue to be the leader - undisputed leader in terms of liquid biopsy, especially in therapy selection. So we're just chugging away. And obviously, as we said, we have all these catalysts coming up in terms of really working at a really much closer level with a lot of the important oncology practices around either through EMR or other sort of center-wide arrangement. And so, we're very excited about what this sort of next phase bodes for Guardant360 testing and Reveal testing.

Jack Meehan

Analyst

Great. And one question for Mike. With the pricing improvement for G360 that you're seeing. I was curious if there's any flag you're willing to put in the ground for cash burn in 2024? Just with the trajectory you're on with that improvement? What's a good landing spot for next year?

Michael Bell

Analyst

I mean I think if you look at our Investor Day slides, we said this year was a year of reduction of cash burn. Next year will be to -- we said over the next five years, we expect the cash burn to come down each year. Although I want to sort of -- cut that because it is a year of launch within screening. We're still making investments on MRD. We will definitely see therapy selection flip to generating positive cash flow. So I think it will be a little bit lower than this year, but not too much lower because, again, we need to invest in the launch. But yes, just to reiterate, we'll end the year with $1 billion in cash, and we still see that as being able to get us through to cash flow breakeven in the five-year time line we pointed out at the Investor Day.

Operator

Operator

Thank you. Our next question comes from Dan Brennan from TD Cowen. Please go ahead.

Dan Brennan

Analyst

Hi, thanks for - thanks for the questions. Congrats on the quarter. Maybe the first one just on Reveal. Could you just kind of walk us through the road map forward in terms of how we should think about filing for expanded coverage both in CRC and then also be interested to hear about what expectations should be for the upcoming data at San Antonio Breast and how that could play into your Medicare filing plans in breast?

Helmy Eltoukhy

Analyst

Yes. So as we speak, we're putting, I think, some of the Kosmos data for colon cancer, getting it ready for publication and so hopefully, once that's published, that is something that would really make up the majority of our submission to MolDx for the expanded surveillance CRC indication. As we speak, we're seeing a lot of, I think, good breast cancer data internally. We've also made a lot of good progress on lung cancer as well. And so we're hopeful that -- we'll be able to have something out there certainly, hopefully published sometime in '24 and have that submitted as well to MolDx. So we think - we're laser-focused on breast, colon and lung cancers. We have obviously multiple other cancers in the pipeline as well, but we think those 3 indications would get us really a long ways of the way we need to be to have a reasonably reimbursed product for Reveal.

Dan Brennan

Analyst

And with the data at San Antonio Breast, that will be a piece of the larger filing package, Helmy for breast?

Helmy Eltoukhy

Analyst

Yes. I mean we continue to have data we had data at ESMO that was a very compelling in breast. I think we'll have some additional data in San Antonio. But we have some other studies as well that may make up the bulk of the submission. So yes, we have sort of multiple shots on goal. I won't be reliant on this one study.

Operator

Operator

Thank you. Our next question comes from Patrick Donnelly from Citi. Please go ahead.

Patrick Donnelly

Analyst

Hi guys. Thanks for the question. Help me maybe just on kind of the core business. It sounded like breast, had the backlog had some benefit from the pent-up demand early in the year, normalized a bit in 3Q. Can you just talk about, I guess, the trends you're seeing there? It sounds like maybe the backlog you had you worked through and now it's just kind of executing on the healthy backdrop, but I would be curious just a little more on the moving pieces there and the right way to think about that going forward?

Helmy Eltoukhy

Analyst

Yes. I think now we're sort of at normalized rates. And now it's just a matter of getting additional patients tested. One thing -- we see a lot of room to grow even for ESR1 and for breast cancer testing, we're seeing data out there that despite our, I think, very large increase in volume of breast testing, and a lot of patients are still being tested by tissue or by other methods to try to assess ESR1. It's very important that physicians know that -- it's very unlikely to detect ESR1 mutation since there are often emergent mutations or distance mutations through our archival tissue biopsy. And so there's obviously, more work to do, but that is a, I think, opportunity for us to continue to increase volumes, I think, considerably. And obviously, in the other cancer types outside of lung and breast I think there's still a lot more room to grow. So CGP, I think, is still not top of mind for many patients. And yes, we're continuing to see, I think, that can be considerable growth for years to come.

Patrick Donnelly

Analyst

Okay. That's helpful. And then maybe just another quick one on Reveal. It sounds like smart liquid biopsy upgrade is on track for the end of the year. Can you just talk through, I guess, the impact there, what we should be thinking as that rolls out?

Helmy Eltoukhy

Analyst

Yes. We're very excited to move to that platform, obviously, as even better performance than where we are now from a sensitivity and specificity point of view, but I think more so, the types of capabilities that assay will be able to provide in terms of not just telling the sort of the what in terms of as the cancer there or not. But what's happening with the cancer or where is the cancer. And so while the transition initially may be somewhat invisible or very low impact, we think, over time, as we start layering in these new futures, it will be really exciting in terms of where the MRD space goes and really using this tool as a sort of blood-based equivalent of a CT scan. I think it's going to be really exciting for the oncology space.

Operator

Operator

Thank you. The next question comes from Derik De Bruin from Bank of America. Please go ahead.

Derik De Bruin

Analyst

Hi. Thanks for taking my questions. Two questions. First, just on the -- going back to V2 on Shield, can you explain why the AA detection didn't go up even though the sensitivity increased pretty significantly between B1 and B2. But just wanting to get my head around that. And then second question would be, any comments on volumes that you're thinking about for 2024 and you still expecting something in the 30s percent growth rate for next year?

AmirAli Talasaz

Analyst

So for Shield, we trying to advance that anomaly, we didn't see improvements on AA side and from that data, it's not very clear exactly how we should read into it. It could have multiple reasons, including the level of shedding of these advanced adenomas signals are still lower than our level of detection. So we -- even with improved detection limits that we have that we can effectively take at least 2x lower levels of tumor in blood, that's not good enough to detect any material amount of advanced adenomas. That could be the reason or it could be like maybe just the biomarkers of advanced adenomas for detection, are different than the current epigenomic and genomic panel that we have that we are detecting CRC with. So still, that's an area that we are looking into. We are doing research. And as we generate more data as we generate more insights, those data and insight would tell us more about what's maybe next for us to get into at least some higher-grade advanced adenomas over time.

Operator

Operator

Thank you. Our final question call comes from Alex Nowak from Craig-Hallum. Please go ahead.

Unidentified Analyst

Analyst

Hi. Good afternoon, everyone. This is [Albert Hu] on for Alex. Can you please outline a bit more on the sales strategy after Shield FDA approval regarding initial sales team, primary call points and just what to expect for 2024?

AmirAli Talasaz

Analyst

Yes. As we outlined in our Investor Day, we are going to expand actually our commercial team, and we are going to have about 100 people, 100, 150 people on the commercial side all in. The call point would be primary care physicians and right now, we have a small sales team in the field that they are promoting and doing some of the market development for Shield even as a lab develop test, but we're going to go through that expansion in near future.

Unidentified Analyst

Analyst

Great. And just as a follow-up also regarding Shield, so what are the back office activities or work reimbursement personnel, customer service, et cetera, do you need to bring - do you need to have ready to bring the test online and get ready for day one of the FDA approval?

AmirAli Talasaz

Analyst

So we have some of those teams already in place because, again, Shield LDT is in the market like many, many thousands of samples have been processed from over 1,000-plus accounts and those teams are in place. It's just a matter of scaling and some of the fixed cost is already there. It's just based on the number of people that we are kind of hire in the field, we need to staff up some other personnel on the client services side, for instance. So all this is already in our commercial plan projections for 2024, and all this is included in the statement that we had that the contribution loss from screening next year would continue to be about approximately $200 million. All those are embedded there.

Operator

Operator

Thank you. With that, we have reached the end of the conference call. Thank you all for attending. You may now disconnect.