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.

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.

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.

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 com...