Guardant Health Sees Shield, MRD and Oncology Testing Growth Accelerate

Key Points

• Guardant Health reported accelerating growth across its oncology testing and minimal residual disease businesses, with Guardant360 revenue growing more than 30% year over year and Guardant Reveal growing more than 100%. The company plans to launch its tumor-informed Reveal Ultra test in 2026.
• Shield colorectal cancer screening adoption is scaling rapidly, with approximately 50% quarter-over-quarter volume growth and broad UnitedHealthcare coverage for eligible patients. Guardant expects its enhanced workflow to reduce Shield’s cost of goods sold by 15% by year-end and is expanding its sales force.
• Guardant is pursuing additional reimbursement and longer-term expansion opportunities, including ADLT status for key tests, broader coverage for Guardant360 and Reveal, and potential future Shield indications in lung and multi-cancer detection.

Guardant Health NASDAQ: GH highlighted growth across its oncology testing, minimal residual disease, and colorectal cancer screening businesses at the Canaccord Genuity Growth Conference, with co-CEOs Helmy Eltoukhy and AmirAli Talasaz pointing to expanding adoption, new reimbursement developments, and planned product launches.

Eltoukhy said the company’s second-quarter performance reflected “a business that’s really firing on all cylinders,” citing three large and overlapping growth opportunities in therapy selection, recurrence detection and cancer screening. He said Guardant360, the company’s liquid-biopsy therapy selection test, delivered more than 30% year-over-year growth, while its tissue test grew at an even faster rate.

According to Eltoukhy, adoption of the company’s Smart Platform, which combines genomic and epigenomic capabilities, has supported volume growth in both liquid and tissue testing. He said the platform’s applications and performance have helped differentiate Guardant360 Liquid CDx, including its ability to identify certain disease characteristics and transitions in lung cancer from blood samples.

MRD portfolio expands with Reveal Ultra

Guardant’s MRD business, centered on its Guardant Reveal test, grew more than 100% year over year, Eltoukhy said. The company launched a therapy-monitoring indication for Reveal in November, and he said the business is benefiting from Guardant’s established relationships with oncologists through Guardant360.

The company expects to launch Guardant Reveal Ultra, its first tumor-informed offering, during 2026. Eltoukhy said the addition would give Guardant a broad oncology testing portfolio spanning liquid, tissue, tumor-informed and tissue-free approaches.

He described tumor-informed and tissue-free MRD testing as complementary opportunities. Tissue-free testing can provide results more quickly and may identify disease beyond the tissue removed in surgery, while tumor-informed approaches can offer deeper sensitivity, he said. Guardant believes both approaches will be important across what Eltoukhy characterized as an approximately 18 million-patient MRD market.

Guardant is pursuing reimbursement progress for Reveal in breast cancer and therapy monitoring through MolDX, Eltoukhy said. He added that demand has been strong even before reimbursement, which he viewed as evidence of product-market fit. The company is also working toward eventual ADLT, or advanced diagnostic laboratory test, status for Reveal and its tissue products, potentially through regulatory pathways.

Shield adoption and payer coverage

Talasaz said Shield, Guardant’s blood-based colorectal cancer screening test, has moved from a category-building phase into a category-scaling phase. Shield recorded roughly 50% quarter-over-quarter volume growth and multi-hundred-percent year-over-year growth, according to Eltoukhy.

Talasaz said adoption by healthcare providers and primary-care physicians, as well as sales-representative productivity, has exceeded the company’s expectations. He also pointed to UnitedHealth Group’s decision to provide broad coverage for Shield for eligible patients in its plans.

Guardant had worked with UnitedHealth for several years, including pilots involving employer populations managed by the insurer, Talasaz said. He said recent colorectal cancer screening guideline inclusion, including by the American Cancer Society, served as a final catalyst for UnitedHealth’s coverage decision.

While the company is holding constructive discussions with other payers, Talasaz said Guardant does not expect another major payer coverage decision before the end of 2026. He added that the American Cancer Society guideline may also support state-level coverage mandates in certain states.

Cost reductions and screening pipeline

Guardant received FDA approval for an enhanced Shield workflow designed to increase laboratory throughput and efficiency. Talasaz said the workflow is expected to lower Shield’s cost of goods sold by 15% by year-end. He said the company is targeting Shield cost of goods sold of about $200 at scale in 2028, compared with approximately $400 reported in the second quarter, while projecting an average selling price above $700 at that point.

The company has more than 400 commercial representatives in the field and plans to expand that organization to between 600 and 700 representatives at steady state, Talasaz said. Guardant is also running national direct-to-consumer and influencer campaigns, although most commercial investment remains focused on field-based promotion.

Shield was developed as a multi-cancer detection platform and has been clinically validated for a panel of 10 solid tumor types, Talasaz said. While it is FDA approved for colorectal cancer screening, Guardant is also conducting a lung cancer screening study. Enrollment has been completed, and the company expects to complete clinical follow-up and the database sometime before year-end or in early 2027.

Guardant also offers patients receiving Shield for colorectal cancer screening the option to receive information on nine additional cancer types through its data initiative program. Talasaz said the majority of primary-care physicians ordering Shield are opting into those multi-cancer reports. The resulting commercial database could ultimately support a future FDA submission to expand Shield’s indication from colorectal cancer screening to multi-cancer detection, he said.

Reimbursement and longer-term opportunities

Eltoukhy said Guardant360 Liquid CDx’s recent FDA approval did not materially affect second-quarter results because the company is phasing its launch. Guardant expects the principal launch to occur after obtaining ADLT designation, which Eltoukhy said has been positioned as a first-half 2027 event. The process includes securing a PLA code and then submitting for ADLT status.

He said broader reimbursement for the therapy-selection test would likely occur in stages, beginning with Medicare Part B, followed by Medicare Advantage and commercial payers, in a process that could take 12 to 24 months.

Beyond oncology, Talasaz said Guardant’s epigenomic technologies have generated early proof-of-concept findings in areas including organ health monitoring, fatty liver disease and neurodegenerative diseases such as Alzheimer’s disease and dementia. He stressed that these efforts remain in early stages, but said the company sees potential to apply its oncology model of screening, monitoring and treatment management in other disease areas.

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.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.

Continue following MarketBeat

Add MarketBeat as your preferred source on Google to see our latest stories in your feed.

Add As Preferred Source