Guardant Health Touts Quest Deal for Shield, Guardant360 Growth and FDA Milestones at Leerink Conference

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<p>Guardant Health (NASDAQ:GH) executives highlighted new commercial initiatives for its Shield colorectal cancer screening test, continued growth drivers for its Guardant360 therapy selection franchise, and upcoming milestones tied to regulatory and reimbursement pathways during a conference discussion hosted by Leerink Partners analyst Puneet Souda.</p>
<p>Quest partnership aims to broaden Shield access</p>
<p>Co-CEO AmirAli Talasaz said Guardant’s newly announced partnership with Quest Diagnostics is intended to make Shield “more broadly available and accessible” and has two primary elements: electronic medical record (EMR) integration and co-promotion.</p>
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<p>On EMR integration, Talasaz said Quest’s connectivity system is used by about 650,000 physicians, enabling Shield to be incorporated into workflows and ordered more easily. He added that the company expects this to increase ordering depth among accounts that already use Quest systems.</p>
<p>On co-promotion, Talasaz said Quest’s primary care channel will detail and educate physicians alongside Guardant’s own commercial efforts. However, he emphasized that Guardant is being conservative in its financial planning, stating the company’s prior guidance for 2026 did not include any incremental contribution from Quest’s co-promotion to Shield volume or revenue. Talasaz said the partnership could have more impact in the second half of the year, with the company looking to provide updates as data emerges.</p>
<p>Guardant360 growth: expanding applications and repeat testing</p>
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<p>In discussing Guardant360, Co-CEO Helmy Eltoukhy described multiple drivers behind the franchise’s growth, including broader adoption of liquid biopsy and expanding clinical applications. He said the field is still not fully penetrated even for “one time per lifetime” use, estimating penetration around 30% to 40% for that initial usage.</p>
<p>Eltoukhy also pointed to increasing test capabilities—such as using methylation signals and other platform enhancements to better characterize tumor biology and histology—as helping move liquid biopsy into broader utility. He framed another long-term growth lever as repeated testing over the course of treatment, enabled by the expanding number of therapeutic options and the need to track tumor evolution.</p>
<p>On repeat testing trends, he said Guardant has been “at that 1.2,” possibly “inching to 1.3” tests per patient on average. He noted that the company has also been increasing the number of newly tested patients, which can keep the average from rising more quickly even as some patients receive multiple tests. Over time, he expects repeat utilization to increase as testing moves closer to “a test per line of therapy.”</p>
<p>Longitudinal testing: SERENA-6 and a blood-based care continuum</p>
<p>The discussion also touched on the SERENA-6 trial context in HR-positive, HER2-negative advanced breast cancer and the potential approval timeline for camizestrant, including an advisory committee meeting scheduled for April 30. Eltoukhy said the company is enthusiastic about the potential approval and suggested an advisory committee is understandable given the “game-changing paradigm” of switching therapy based on molecular progression.</p>
<p>He said an approval could help drive a shift toward longitudinal testing, potentially making tumor evolution and repeated assessment more “top of mind” for physicians. He also noted developments with competitor drugs that, in his view, may increase the likelihood that testing will be required for certain ESR1-directed therapies.</p>
<p>Eltoukhy outlined Guardant’s view of a continuum of care that uses blood-based testing across multiple stages. He described a model where Guardant360 is used for upfront therapy selection, and Guardant Reveal can be used to assess whether a therapy is working and to monitor response in a way that can provide a more real-time view than imaging. If disease progresses, he said clinicians can return to Guardant360 to reassess tumor drivers and guide therapy changes, repeating the cycle.</p>
<p>He added that the company expects these paradigms to move earlier in disease over time, citing a recent colorectal cancer guideline update indicating comprehensive testing even in stage II and stage III settings. When asked about scope, he clarified the change discussed was “just CRC” currently, and suggested the patient population could increase meaningfully—potentially on the order of a 50% to 75% increase—if earlier-stage comprehensive profiling expands.</p>
<p>Regulatory and reimbursement: FDA timeline and ADLT implications</p>
<p>Eltoukhy said Guardant remains on track for FDA approval of Guardant360 in the second half of the year. He called it a “major catalyst,” including for simplifying what he described as a “complicated portfolio” that can create confusion across multiple tests. He said consolidating around a single flagship test that is FDA approved and includes platform capabilities could boost Guardant360 performance.</p>
<p>On the potential for Advanced Diagnostic Laboratory Test (ADLT) pricing, Eltoukhy said an ADLT reprice would likely be finalized in the first part of 2027, describing it as a procedural process for an FDA-approved test that qualifies.</p>
<p>CFO Mike Bell said Guardant360’s current average selling price (ASP) is around $3,100 and that an improved ADLT rate would be expected to have a positive impact if it comes in 2027. He also said the company expects ASP uplift across the oncology portfolio, including pursuing MolDX coverage for Guardant Reveal in breast cancer and in immunotherapy and chemotherapy settings, with additional efforts “in the works.”</p>
<p>Bell added that the company is also reducing cost per test and improving gross margins, and said Guardant is committed to reaching cash flow breakeven by the end of 2027—after previously bringing that target forward by a year. He said incremental gross profit from ASP improvements would be balanced between moving breakeven sooner and reinvesting in growth and innovation.</p>
<p>Shield commercialization: DTC, salesforce ramp, and ASP strategy</p>
<p>On Shield marketing, Talasaz said Guardant conducted direct-to-consumer (DTC) pilots in 2025 and is expanding efforts “step by step” in 2026 while measuring ROI. He noted the company recently announced a partnership with cancer advocate Patrick Dempsey as a brand ambassador, and described targeted TV campaigns aimed at people eligible for CRC screening.</p>
<p>Bell said company-wide operating expense growth is expected to be roughly 14% to 15% for the year, with the “vast majority” of incremental OpEx going to sales and marketing. He said much of that spend is directed toward screening, including DTC and continued expansion of the field sales team, while R&amp;D and G&amp;A are being kept relatively flat.</p>
<p>On Shield guidance, Talasaz said Guardant’s plan includes productivity improvements from the screening salesforce, which grew from 100 reps at the start of the prior year to 300 reps by year-end. He also listed several elements not included in guidance, including potential upside from an anticipated American Cancer Society (ACS) guideline recommendation, Quest co-promotion success (beyond some EMR-related benefits), newer health system engagement efforts, and international expansion.</p>
<p>When asked for an update on ACS guidelines, Talasaz said Guardant remains in contact with ACS and that the “tone of conversation continues to be very positive,” adding the company is optimistic a recommendation could come in the “very near future,” though timing has slipped from prior expectations.</p>
<p>Bell also addressed Shield ASP dynamics, saying the company guided to a 2026 full-year ASP of around $775, describing the decline as deliberate as Guardant allows more under-65 commercial volume to come through in certain areas despite “a lot of zeros” from commercial payers. He said the Medicare ADLT rate is $1,495 and cited strong reimbursement from Medicare Advantage payers. Bell added that once commercial payments begin in states where access expands—something he suggested may take about 12 months—Guardant would expect ASP to start rising again, anchored to the Medicare rate.</p>
<p>About Guardant Health (NASDAQ:GH)</p>
<p>Guardant Health, Inc is a precision oncology company specializing in blood-based cancer diagnostics. Founded in 2012 and headquartered in Redwood City, California, the company develops non-invasive tests that use circulating tumor DNA (ctDNA) to profile genomic alterations in patients with solid tumors. Guardant Health's mission is to advance cancer care by providing actionable data to clinicians, pharmaceutical partners and researchers worldwide.</p>
<p>The company's flagship product, Guardant360, is a next-generation sequencing (NGS) assay designed to detect mutations, copy number variations and select fusions in more than 70 cancer-related genes.</p>