GRAIL Highlights Galleri Growth Ahead of Key FDA Advisory Meeting

GRAIL NASDAQ: GRAL Chief Financial Officer Aaron Freidin said the company’s Galleri multi-cancer early detection test recorded strong first-half growth as it expanded distribution through digital health platforms, employers and physician offices.

Speaking at the Canaccord Genuity Growth Conference, Freidin said GRAIL generated approximately 30% revenue growth and 42% test-volume growth in the first half, with more than 117,000 tests completed. The company has been focused on building a market for Galleri through self-pay and reimbursement-related channels, including digital health providers, self-insured employers and traditional physician practices.

“The things really driving growth right now are traction in those channels, and then the education of those sales reps now having the ASCO data in hand,” Freidin said, referring to data from the NHS-Galleri study presented at the American Society of Clinical Oncology meeting.

Sales Force and Digital Health Expansion

GRAIL expanded its sales force during the second quarter and completed training by the end of the period, Freidin said. Sales representatives have also been trained on the NHS-Galleri results and are using the data in physician discussions.

The company’s integrations with Quest Diagnostics and athenahealth have been in place for more than a year, according to Freidin. He said ordering becomes easier once physicians are familiar with the test and have experience detecting cancers through it. GRAIL expects to integrate with Epic by the end of the year, which Freidin said should further reduce ordering friction.

Digital health represents a significant opportunity, he said. GRAIL’s partner Function targets consumers who are proactive about their health, a customer profile that aligns with cancer screening before symptoms emerge. Freidin said digital-health channel volumes doubled year over year on a quarterly basis.

GRAIL also launched with Hims & Hers earlier in the year, though Freidin said that company’s attention has been more focused on its GLP-1 business than its laboratory offerings. He characterized additional investment by Hims & Hers in its labs business as a potential source of future upside.

Pricing, Margins and Capacity

Galleri’s patient-pay price is about $950, while GRAIL reported an average selling price of roughly $700 per test, according to the conference discussion. Freidin said the company began using volume-based contracts with physicians, health systems and employers last year, lowering prices as volumes rise.

He said GRAIL expects the eventual Centers for Medicare & Medicaid Services reimbursement rate to be around $500. At that price, the company believes it can operate with gross margins of 50% to 60% at scale using the current version of its test.

GRAIL’s laboratory can process more than 1 million tests annually, Freidin said, compared with an implied annualized volume of about 240,000 tests based on first-half activity. The company is therefore focused on gaining leverage from its fixed-cost infrastructure. He described the lab as highly automated, with limited manual handling after sample tubes enter the processing workflow.

FDA Review and Clinical Data

Freidin said GRAIL’s upcoming Food and Drug Administration advisory committee meeting is expected to focus on Galleri’s performance and efficacy data. The company submitted Galleri for premarket approval in January 2026, and the advisory committee meeting is scheduled for Sept. 23.

He said GRAIL has had an “iterative and collaborative” review process with the FDA and expects the advisory committee discussion to address measures such as positive predictive value, specificity and cancer signal detection rate. Freidin said the company is preparing for a range of possible outcomes from the meeting.

GRAIL has emphasized results from the NHS-Galleri trial, which did not meet its primary endpoint but showed more than a 20% reduction in stage IV cancers, according to Freidin. The study also found more stage I and II cancers, and he said the results reflected a greater-than-expected amount of stage III cancer already present in the population at baseline.

Freidin said the findings have resonated with oncologists because earlier-stage cancers may more often be treated with curative intent. He added that the company plans an additional 12 months of follow-up in the NHS-Galleri study, with data expected in the first half of 2027. A nested mortality analysis is expected to read out sometime in 2028.

The company also submitted results from its PATHFINDER 2 study to the FDA. Freidin said the study, which included about 35,000 participants, showed that Galleri’s performance in an intended-use screening population remained consistent with or improved from the earlier PATHFINDER study.

Reimbursement and International Plans

Freidin said GRAIL is in early discussions with CMS regarding potential national coverage after FDA approval. He said the REACH study, designed for the Medicare population, will be important to those discussions because it is evaluating clinical utility and reductions in late-stage disease. The study was originally designed to read out in 2030 or 2031, although GRAIL may provide data along the way.

Internationally, GRAIL is discussing next steps with the U.K.’s National Health Service. Freidin said the NHS has reviewed the data, but decisions will also involve political and budget considerations and are not expected to move quickly.

The company also completed a $110 million financing associated with its Samsung agreement in June. The arrangement will initially involve Samsung establishing a sales force in Korea and selling Galleri tests into that self-pay market, with samples sent back to GRAIL. If the initial phase is successful and GRAIL receives FDA approval, the partnership could expand to Japan and potentially include a laboratory buildout.

GRAIL ended the quarter with about $900 million in cash, Freidin said. The company expects cash burn of less than $300 million for the year but may continue investing in sales and commercial infrastructure if demand proves durable ahead of broader reimbursement.

About GRAIL (NASDAQ:GRAL)

GRAIL, Inc NASDAQ: GRAL is a biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test. Leveraging advances in next-generation sequencing, cell-free DNA (cfDNA) analysis and machine learning, GRAIL has developed the Galleri™ test, which aims to identify more than 50 types of cancer at their earliest stages. The company's platform analyzes methylation patterns in circulating tumor DNA to pinpoint tumor presence and tissue of origin, enabling physicians to pursue timely diagnostic follow-up.

Founded in 2016 as a spin-out from Illumina, GRAIL established its headquarters in Menlo Park, California, with additional research and operations centers in the United Kingdom.

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