Guardant Health, Inc. (NASDAQ:GH) Q3 2023 Earnings Call Transcript

Guardant Health, Inc. (NASDAQ:GH) Q3 2023 Earnings Call Transcript November 6, 2023

Guardant Health, Inc. beats earnings expectations. Reported EPS is $-0.73, expectations were $-0.93.

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: 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: 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 which letter positioned to order a colonoscopy. Though she had been hesitant of a colonoscopy at her initial visit with this result of Shield she prioritized getting the procedure done. The colonoscopy determined that she had stage 2 colorectal cancer. She started receiving chemotherapy right away followed by surgery to remove a portion of her colon. After surgery and just a few months of treatment she was healthy again. With their cancer caught early she was able to participate in her son’s wedding this past fall. This story is a powerful example of delivering on our commitment to increase colorectal screening compliance through the preference and ease of use in the physician’s workflow.

Serving this patient and the millions of others just like her who will face cancer this year is why we exist. The results we share today reflect the positive progress we are making in our mission to help as many of these patients as we can. Turning to top-line performance on Slide 4. We are pleased with our third quarter results with revenue growing another 22% this year to $143 million. This solid growth was driven by precision oncology revenue, which increased 31% in the quarter. We continue to see strength in our core therapy selection business with a number of tailwinds to drive growth over the long term. Turning to Slide 5. We delivered strong growth across precision oncology with a record number of combined tests during the quarter. Clinical test volume during the third quarter reached 43,900 tests, an increase of 35% from the prior-year quarter.

Clinical growth was driven by strong contributions from our key products, supported by a robust commercial platform. For biopharma, we delivered 7,500 tests increasing 11% year-over-year. Turning to Slide 6. Looking more closely at some of the highlights from the third quarter. We continue to benefit from tailwinds seen earlier in the year with another quarter of solid year-over-year clinical volume growth across Guardant360 and TissueNext. Notably, nearly half of oncologists in the United States are now ordering a Guardant360 test every month which highlights the strength of our core therapy selection business. As is typical with new approvals following the Guardant360 CDx approval for ESR1 mutation-positive patients, we saw a spike in breast volumes in Q1 and Q2, fueled by pent-up demand.

In Q3, we had worked through this backlog and therefore had sequentially less breast cancer tests in Q3 than in Q2. That said, we still had strong contribution from breast volume in the quarter, which increased significantly year-over-year and we expect to see continued growth in this indication. Our team remains focused on investing in our commercial infrastructure and providing the best customer experience. Last week we announced the integration of our CGP tests within Flatiron oncology EMR. With this underway, we are in the process of integrating the top three oncology EMR providers in the United States. These providers collectively represent approximately two third of all oncology practices in the country and these integrations are expected to reduce oncologists ordering time by 75%.

Notably, by the end of the year, we expect to be fully integrated in over 400 accounts. In addition to the customer experience benefits and efficiencies gains, we expect these partnerships to contribute to an uplift in ordering volumes in 2024. We are also seeing growing contribution from MRD with another quarter of record volumes for Guardant Reveal. We are on track to upgrade Reveal with smart liquid biopsy by end of this year. As we shared at our Investor Day, we are expanding into other geographies and are seeing an increasing contribution from labs globally. This quarter we saw good momentum, particularly in Europe as the Royal Marsden Guardant powered Laboratory was awarded an expression of interest by the NHS to launch CDP for non-small cell lung cancer in England potentially making this technology accessible to thousands of patients across the country.

We are also making good progress in Asia with the recent launches of our assays for biopharma use in China and of Guardant360 for clinical use in Japan. In early September Guardant360 CDx received regulatory approval in Japan as a companion diagnostic to ENHERTU for treatment of non-small cell lung cancer patients with HER2 mutations. This follows the recent national reimbursement approval for Guardant360 CDx in Japan, which became effective at the end of July. We are really excited about the opportunity in this market as Japan currently represents the largest expansion opportunity within our portfolio. While international revenue has historically been a relatively small portion of volumes, we expect significant growth from this core markets over the next year.

Moving on to Slide 7. In the third quarter, we continue to see breakthroughs in payer coverage that provide tailwinds for our clinical business in the near term. Starting with therapy selection. We are starting to see the impact of the recent coverage wins for Guardant360 with ASP now towards the upper end of the $2650 to $2700 range. While this marks significant progress so far this year, our ASPs will increase meaningfully more throughout the next few months. In late September, CMS proposed to crosswalk Guardant360 LDT to a price of $5,000 as part of the rate-setting process for reimbursement under the Medicare Clinical Lab Fee Schedule next year. It finalized this will be a major milestone for Guardant. It will have a meaningful impact on our top and bottom line.

Mike will share more about the uplift we expect to see in our ASP shortly. We are also working to expand private payer reimbursement with the ultimate goal of getting national biomarker testing coverage. We are seeing important inroads made here. To date 13 states, most recently California have enacted biomarker bills into law that require providers to cover biomarker testing. Collectively, these inactive bills cover nearly half the U.S. population. Two more Ohio and New York are pending. In many cases, these bills support private payer coverage for both therapy selection in MRD. We will continue to support efforts by the American Cancer Society and others to get these bills passed and more states expand access to comprehensive biomarker testing through broadening private payer coverage.

Lastly, we are continuing to make progress with the reimbursement for TissueNext and recently surpassed 200 million covered lives. For MRD we also received coverage for Guardant Reveal from the Geisinger Health Plan providing coverage for more than 0.5 million members. The test will be covered when you use after surgery or curative treatment to inform physicians decision about adjuvant therapy and to monitor for disease progression recurrence or relapse. This builds on the previous coverage we received from Blue Cross and Blue Shield of Louisiana. We look forward to continuing to drive adoption of Reveal and additional reimbursement wins. Moving on to Slide 8 to discuss some recent data for Reveal. In October PEGASUS interim data was released as a late-breaking abstract at the ESMO Congress.

PEGASUS is a de-escalation clinical utility study for post-surgical liquid biopsy guidance treatment of 135 Stage 3 and high-risk Stage 2 colorectal cancer patients. Initial results show that 34% of patients with a positive liquid biopsy results after surgery had their cancer relapse despite initiation of adjuvant chemotherapy. In addition, only 10% of patients with the negative result experienced a relapse. Approximately 40% of patients converted from ctDNA positive to ctDNA negative after treatment suggesting treatment efficacy of chemotherapy for some patients. These results are promising and suggests that our Reveal blood test do provide a sensitive tool to help oncologist make informed treatment decisions, that improve outcomes for their patients.

We expect full readout of this study in 2024. With that I will now turn the call over to AmirAli to provide an update on our screening business.

AmirAli Talasaz: 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 a 100% and sensitivity in detecting advanced adenoma was similar. This data gives us confidence that the clinical sensitivity of Shield V2 will be higher than the current Shield V1. We plan to conduct a regulatory grade clinical study utilizing our already biobank samples that were collected during ECLIPSE study to assess the performance of Shield V2. Pending a successful readout we will submit a supplemental PMA with the potential for approval in 2025. Moving on to Slide 11.

At the American College of Gastroenterology or ACG Annual Meeting in October, we presented some additional data about the real-world adherence rate with Shield and new insights from our health outcome models. In addition, Kaiser Permanente Center for Health Research presented data on their experience with Shield and the perception of blood-based testing for colorectal cancer screening from both patients and providers. The results of the randomized prospective trial were overwhelmingly positive for Shield. In this study, providers offer the Shield blood test to a randomized cohort of patients who have not completed the FIL test. Patients who were offered Shield we more than two times as likely to complete CRC screening, compared to the patients receiving usual care.

In addition, the study found that the patient and provider surveyed were enthusiastic about the potential for blood-based CRC screening tests to increase compliance. Last month, we reached an important milestone with the first publication of blood-based CRC screening testing in Annals of Oncology. This study was run on an early prototype of what is now Shield and highlights how and accessible and convenient blood test helps to increase effectiveness of CRC screening. We have always had a vision for blood-based multi-cancer screening. We started with CRC as the first indication for Shield because of the established pathways for FDA approval and reimbursement, which allow for broad access. We are working to add lung cancer as a second indication, followed by an expansion into other cancers.

We are continuing to make good progress in enrollment into our lung cancer screening trial and look forward to beginning enrollment for our interventional and MSET study next year. With that, I will now turn the call over to Mike for more detail on our financials.

Michael Bell: 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 primarily driven by strong year-over-year growth in clinical and biopharma volumes. Precision oncology revenue from clinical tests in the third quarter totaled $103.9 million, up 34% from $77.8 million for the prior year quarter. Third quarter clinical test volume was 43,900 an increase of 35% from the same period of the prior year. Guardant360 continues to be the main revenue driver with continued strong year-over-year growth. As Helmy mentioned following the Guardant360 CDx approval for ESR1 mutation positive patients. We saw a spike in breast volumes in Q1 and Q2, fueled by pent-up demand.

In Q3, we had worked through its backlog and therefore sequentially less breast cancer tests in Q3 than in Q2. That said, we still have strong contributions from breast volume in the quarter, which increased significantly year-over-year and we expect to see continued growth in this indication. Also note, that the third quarter. Clinical revenue includes the payment of $3.6 million received from Medicare related to a successful appeal claims data between 2018 and 2020. This was a one-time payment and there are no other outstanding claims that have yet to go through this, the appeal process. Excluding the $3.6 million payment, the blended clinical ASP was approximately $2,300. Which is consistent with the previous quarter and in line with our expectations.

As a reminder, lending clinical ASP will continue to be influenced by both the volume mix between Guardant360 TissueNext and response, as well as the mix of overall clinical volume between the U.S. and International. Precision oncology revenue from biopharma tests in the third quarter. Total $29.5 million of 22% from $24.2 million for the prior year quarter. Biopharma test volume was strong with third quarter totaling approximately 7,500 tests up 11% from the prior year quarter. Biopharma ASP in the third quarter was approximately $3,900. Which was higher than both last quarter 3,700 and the prior year quarter at 3,600 due to the product mix. Development services and other revenue in the third quarter totaled $9.6 million down $5.7 million or 37% from the prior year quarter.

As we communicated last quarter. This was anticipated and was primarily due to the timing and amount of milestones related to our partnership agreements and companion diagnostic collaboration projects with biopharma customers as well as the reduction in royalty revenue. Gross profit for the third quarter of 2023 was $85.4 million compared to a gross profit of $76.9 million in the same period of the prior year. Gross margin was 60% compared to 66% in the prior year quarter. So Precision Oncology, gross margin was 60% in the third quarter of 2023, which was slightly lower than 61% in Q3 2022. Primarily due to changes in the product mix. Development Services and other gross margin was 59% in the third quarter of 2023 compared to 93% in Q3 2022.

The change in margin was primarily due to the cost of processing Shield LDT samples as part of our market development activities, for which we are currently booking minimal revenue. We continue to expect overall gross margins to be approximately 60% for the full year 2023. Operating expenses for the third quarter of 2023 are $199.0 million. A reduction of $22.5 million compared to $221.5 million in Q3 2022. Net loss was $86.1 million or $0.73 per share for the third quarter of 2023 compared to $162.0 million or $1.58 per share in the third quarter of 2022. The $75.9 million year-over-year reduction in net loss is primarily due to a $31.1 million year-over-year improvement in our loss from operations. A $29.9 million positive change in unrealized gains and losses recorded for our equity investment in Lunit and a $9.9 million increase in interest income.

Moving on to non-GAAP financial measures. On Slide 14. Non-GAAP operating expenses were $177.3 million for the third quarter of 2023. A reduction of $23.2 million compare to a $200.5 million in the prior year quarter. Non-GAAP net loss was $79.2 million or $0.67 per share for the third quarter of 2023 compared to $120.8 million or $1.18 per share for the third quarter of 2022. Adjusted EBITDA was a loss of $79.7 million in the third quarter of 2023. Compared to a $112.8 million loss in the third quarter of 2022. Free cash flow for the third quarter of 2023 was negative $80.2 million, compared to negative $99.9 million in Q3 2022. We continue to make very good progress in managing our operating expenses and cash burn. And we remain on track to achieve our goal of lowering our full year operating expenses compared to 2022.

As well as reducing our free cash flow to approximately negative $350 million for the full year. We ended the third quarter of 2023 with cash of approximately $1.2 billion. As we laid out at our recent Investor Day. We expect our current cash will provide the runway to reach cash flow breakeven, which we are targeting in 2028. In addition, we are on track to achieve our targets of reaching cash flow breakeven in therapy selection by the end of this year and look managing the annual screening cash burn to be approximately $200 million. We continue to expect that our annual cash burn screening will be approximately $20 million over the next five years. Now turning to our outlook for the full year 2023 on Slide 15. We are raising our full-year 2023 revenue guidance and now expect revenue to be in the range of $553 million to $556 million, representing growth of approximately 23% to 24% compared to 2022.

This compare to our previous expectation of $545 million to $550 million. Additionally as just mentioned, we continue to expect 2023 operating expenses to be below full-year 2022 and free cash flow to improve to be approximately negative $350 million in 2023. Turning to Slide 17, our long-term vision is to transform cancer diagnostics through cutting-edge technology. A focus on high impact opportunities and consistent execution. In the third quarter, we achieved our goal of 200 million covered lives for TissueNext. And we remain on track to achieve the remainder of our stated milestones. At this point. We will now open the call to questions.

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Q&A Session

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

Tejas Savant: 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: 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: That was just on the private payer side of things.

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

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

Mark Massaro: 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: 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.