Guardant Health (NASDAQ:GH) executives said momentum in oncology testing and colorectal cancer screening supported the company’s first-quarter outperformance and full-year guidance increase during a Bank of America fireside chat.
Mike Bell, Guardant Health’s chief financial officer, said the company’s guidance raise was driven by two main factors: oncology volume and Shield volume. In oncology, Bell pointed to strength in Guardant360 and the company’s Smart Platform. He said Guardant started the year strongly and expects additional Smart Apps to act as catalysts through the year.
Shield Volume Outlook Supported by Sales Force, Quest and Marketing
On Shield, Guardant’s blood-based colorectal cancer screening test, Bell said the company saw stronger momentum in March and expects several growth drivers to contribute through the year. These include better sales representative productivity, additional sales reps, the recently initiated Quest collaboration and direct-to-consumer marketing efforts.
Bell said Guardant is confident in an average sequential increase of about 10,000 Shield tests per quarter. He said the near-term driver remains the sales force, while Quest and direct-to-consumer marketing are expected to have a greater impact in the second half of the year.
Bell also said potential ACS guideline inclusion is not currently reflected in Guardant’s 2026 guidance. If it occurs, he said it could create upside by allowing the company to reach more patients under 65 in applicable states and drive more commercial volume. However, he said the revenue impact would likely be more meaningful in 2027 because commercial payer reimbursement would take time to develop.
Discussing average selling price for Shield, Bell said the company has focused since launch on reimbursable tests, particularly Medicare-age patients. He cited the Medicare fee-for-service ADLT rate of $1,495 and improving payments from Medicare Advantage plans. As Guardant opens up more under-65 volume through Quest, marketing and potential ACS guideline changes, he said the company expects ASP to tick down initially because of more commercial zero-payment claims, then recover over time as commercial payers begin paying.
Executives See More Room in Therapy Selection
Helmy Eltoukhy, Guardant’s co-chief executive officer, said liquid biopsy therapy selection still has “so much more room to grow,” noting that many cancer patients are not retested at each progression despite guidelines and clinical practice supporting additional genomic profiling as disease changes.
Eltoukhy said many patients still do not receive initial comprehensive profiling, particularly on the liquid biopsy side. He said Guardant believes it is benefiting from product-market fit with its Smart Platform and share gains in liquid testing.
He described Guardant360 Liquid as the “tip of the spear” for the company, with the Smart Platform helping support use of tissue testing, Guardant Reveal and therapy monitoring. Eltoukhy said it will become increasingly difficult for providers to use multiple testing companies when physicians want a unified view of a patient over time.
Smart Apps and AI Discussed as Growth Enablers
Eltoukhy said Guardant has seen accelerated growth in Guardant360 Liquid since launching the Smart Platform in 2024 and expects that to continue into 2026 and beyond. He said the company has more than 500,000 methylation profiles and is using growing datasets to train algorithms and develop new applications.
Eltoukhy also said artificial intelligence has been “transformational” for Guardant across functions, including legal, human resources, operations, software, reimbursement, appeals, regulatory submissions and research and development. He said about 50% of the company’s software is now written by AI and that AI has improved the speed of algorithm development and software deployment.
Regulatory, Reimbursement and Legal Questions Addressed
Asked about the SERENA-6 advisory committee discussion, Eltoukhy said a positive takeaway was that committee members and key opinion leaders broadly supported ctDNA testing as part of the future of oncology, despite a mixed decision. He said Guardant’s primary plan for longitudinal testing and adaptive disease management remains Guardant Reveal for therapy monitoring.
On broader diagnostics reimbursement concerns related to CLFS, Eltoukhy said Guardant believes it is less affected than most because many of its products are tied to national CMS pathways. He cited Shield’s national coverage decision, Guardant360 CDx and the expected path for Guardant360 Liquid after FDA approval. He also said the issue is distinct from PAMA, which he characterized as requiring legislative action and not currently at risk.
Eltoukhy also addressed a civil investigation in Florida disclosed in Guardant’s 10-Q, calling such inquiries “normal course of business” for the industry. He said Guardant takes the matter seriously and will respond, but does not view it as material, citing the company’s compliance program.
Profitability Targets Remain in Focus
Bell said Guardant is managing investments by separating screening from the rest of the business. He said the non-screening business has been free cash flow positive and adjusted EBITDA positive since the middle of last year and is expected to remain so in 2026.
For screening, Bell said Guardant is reinvesting incremental gross profit into sales and marketing to capitalize on its first-mover position and expand the field team. He said the company expects an inflection point in 2027, when screening reaches greater scale and incremental gross profit can begin contributing more to the bottom line. Bell said Guardant remains committed to reaching breakeven by the end of 2027.
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.
