Guardant Health (NASDAQ:GH) executives used a Barclays discussion to outline growth drivers across treatment selection, minimal residual disease (MRD) testing, and colorectal cancer (CRC) screening, while addressing investor questions on clinical utility, reimbursement, and commercial execution.
Treatment selection: ESR1 monitoring and Guardant360 expansion
Co-CEO Amirali Talasaz said Guardant Health’s three major business “drivers and brands” are treatment selection, MRD, and screening, and he characterized each as offering “opportunities for hypergrowth.” In treatment selection, he pointed to Guardant360’s role in liquid comprehensive genomic profiling (CGP) and highlighted monitoring for ESR1 mutations in breast cancer as an emerging opportunity.
Discussion centered on the SERENA-6 trial, in which Guardant’s pharmaceutical partner AstraZeneca is monitoring patients to detect ESR1 in blood and using it as a surrogate marker to guide a treatment switch. Talasaz said the trial readout was discussed at ASCO and that an FDA decision is expected in the first half of the year. He noted the company’s view that ESR1 is “uniquely” detectable via liquid biopsy and framed the opportunity as a shift from single time-point testing at progression to multiple time points of testing during a treatment course.
Looking to the commercial implications, Talasaz estimated about 40,000 breast cancer patients could be candidates for this type of monitoring if the associated drug is approved for the indication, with testing potentially occurring three to four times per year. He said Guardant has not included this opportunity in its 2026 guidance and prefers to wait for FDA approval before incorporating it into expectations, then assess the post-approval volume impact.
Talasaz added that the program would be associated with AstraZeneca’s drug and would represent a new companion diagnostic (CDx) for Guardant360—what he called the first “monitoring CDx” for the test. He said Guardant360 already has 25 approvals, but described those as linked to single time-point treatment decision-making rather than monitoring.
CRC FDA approval, reimbursement conversations, and payer dynamics
Talasaz also discussed an FDA approval Guardant360 received in January for CRC, describing it as the company’s first approval for Guardant360 in that indication. While he said CGP utility in CRC is well established, he argued that FDA-approved indications can increase physician confidence and utilization. He also said such approvals can strengthen discussions with commercial payers and potentially help address remaining reimbursement gaps.
After “10 years,” Talasaz said Guardant360 reimbursement is in a strong position overall, though he acknowledged there are still cases where the company does not receive good payment from payers. He said the company’s experience is that FDA approvals can improve payer conversations for specific indications, potentially supporting coverage and average selling price (ASP) over time, though he emphasized it would take time to realize.
Platform strategy: genomic and epigenomic data, “Smart Apps,” and MetaSight
In response to questions about technology direction, Talasaz emphasized Guardant’s “data moat” and “flywheel of data,” citing genomic data from 1 million patients and “many hundreds of thousands” of patients with full epigenomic data. He described epigenomics as the “dark matter of biology” in cancer understanding and said the dataset is already paying dividends in technology and application development.
As an example, he said Guardant has developed “Smart Apps” that generate clinical information for physicians, including an application for patient subtyping enabled by the company’s database. Talasaz said the company is layering additional data sources “step by step” and referenced the recent acquisition of MetaSight as adding a complementary technology layer that could extend insights beyond ctDNA, genomics, and epigenomics and potentially improve products across the portfolio.
Reveal MRD: growth, surveillance pull-through, and Reveal Ultra timing
CFO Mike Bell said Guardant does not break out Reveal volumes, but he indicated the analyst’s estimate of roughly 60,000 tests was “broadly in the right ballpark.” Bell said Reveal has been Guardant’s fastest-growing oncology product by volume for the last few years and that the company expects it to remain so this year. He also said the company is “very bullish” on Reveal for 2026.
On surveillance testing frequency, Bell said CRC surveillance reimbursement has been in place for roughly 12 months and that the company is seeing good traction and pull-through. He said commercial operations have been focusing on the surveillance aspect and improving mechanisms to pull patients through to subsequent tests, adding that tests per patient are improving.
Talasaz discussed a longer-term vision for MRD that could extend beyond a binary positive/negative result. He described a future where MRD testing could help determine not only whether residual disease is present, but also where it is located and how it can be characterized—though he said this is not “prime time” and framed it as an aspirational direction.
Regarding Reveal Ultra, Talasaz said Guardant is currently a leader in tumor-naïve MRD and is moving into tumor-informed MRD with Ultra, built on a new technology stack. He said the product is on track to launch later this year, but that it is not included as a revenue contributor in 2026 because it will be new, likely without immediate reimbursement at launch, and subject to adoption dynamics. Bell said reimbursement for Ultra is “to be determined,” noting that CRC reimbursement is $1,644 and that a base case assumption would place Ultra in that ballpark, pending the MolDX process.
Asked about the technology enabling low detection limits, Talasaz said the company has not disclosed details of the technology stack, but suggested more information will be shared closer to launch.
Shield CRC screening: care-gap focus, sales execution, and Quest partnership
On screening, Talasaz described Shield as “probably the biggest diagnostic brand ever” and said that in its first full year of launch, it was the best diagnostic launch outside of COVID testing. He said Guardant’s messaging is focused on unscreened patients in primary care settings, describing a “54 million patient opportunity.” Talasaz said that based on the medical information Guardant has, about 90% of Shield-tested patients had not been screened in the prior five years, which he said indicates the company is filling a care gap.
Bell said Guardant’s guidance includes an expectation of 150% volume growth and that the assumptions are primarily driven by commercial execution rather than inclusion in guidelines or quality metrics. He said the company has not baked in inclusion in American Cancer Society (ACS) guidelines, USPSTF, or quality metrics such as HEDIS, describing ACS inclusion as a potential near-term upside. Bell emphasized increasing productivity from the existing 300 sales reps, adding reps and territories, and the launch of a direct-to-consumer (DTC) campaign, which he said is showing promising early signs.
Bell also pointed to a newly announced partnership with Quest, which he said will help fast-track electronic medical record (EMR) connectivity and is included in guidance. However, he said Guardant has not included potential incremental upside from Quest reps educating their accounts about Shield, calling it a possible additional driver if it proves effective.
Talasaz said the launch has been targeted toward clinicians experienced with non-invasive CRC screening and toward high-volume Medicare beneficiary practices, reflecting reimbursement status at launch. While he said the company now has nationwide coverage, he noted there are about 250,000 potential primary care physicians with CRC screening experience and said Guardant is “just scratching the surface.” He added that the company remains focused on unscreened patients rather than directly competing for share with stool-based testing, while acknowledging it is seeing some unpromoted use cases such as re-screening patients switching modalities and testing between colonoscopy intervals.
On DTC, Talasaz said the company is targeting patients 45 and older and “double indexing” on those 65 and older. He characterized the campaign as not yet “full force,” but said Guardant is pleased with early results.
About Guardant Health (NASDAQ:GH)
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.
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.
