January 12, 2026 | Grail returned to the 44th Annual J.P. Morgan Healthcare Conference for its second appearance as an independent public company, and CEO Bob Ragusa had positive momentum to report, though the tipping point is still expecting mid-2026 with the readouts of two major clinical trials. The multi-cancer early detection company is closing in on a critical regulatory milestone while demonstrating strong commercial traction.
"We're at the very beginning of an exciting journey to fundamentally change the way we screen for cancer," Ragusa told attendees at the San Francisco event.
That journey took a significant step forward in Q4 2025, when Grail strengthened its balance sheet with approximately $435 million in new capital, including a $325 million private placement investment and $110 million through its at-the-market program. An additional $110 million equity investment from Samsung is expected to close this month, which, along with existing reserves, brings the company's cash position to $904 million.
"These transactions provide us with financial flexibility to navigate our growth ramp over the next several years as we pursue critical milestones to support regulatory approval and broad access," Ragusa said.
The company reported selling more than 185,000 Galleri commercial tests in 2025, representing 35% volume growth year-over-year. Much of that increase came from both breadth and depth of prescribing, with the prescriber base growing approximately 30% to over 17,000 physicians. The repeat test rate also climbed above 30%, giving the company confidence that both physicians and patients see value in annual testing.
Total revenue for 2025 is expected to land between $147 million and $148 million, representing 17-18% growth over 2024. U.S. Galleri revenue specifically will come in between $136 million and $137 million, a 25-26% increase over the prior year's $108.6 million.
Importantly, Grail achieved this growth while dramatically reducing cash burn. Full year 2025 cash burn was approximately $274 million, compared to $579 million in 2024—a reduction accomplished through significant reorganization in the second half of 2024.
For 2026, the company expects total Galleri revenues to grow 22-32% with cash burn remaining under $300 million. The current cash balance provides runway into 2030, Ragusa said.
Expanding Through Partnerships
Grail has been building a multi-pronged partnership strategy to drive market adoption. Operational partners like Quest and Athena have helped create an "easy button" for physician ordering. Telemedicine provider Recuro Health supports simple access through Galleri.com and workflow for employer customers.
Health system partners are implementing Galleri into screening populations and enabling workups for positive tests while capturing real-world evidence. High-profile systems including Mayo Clinic and Dana-Farber have published their own experiences with Galleri, reporting positive predictive values of 70-80% at major medical conferences.
Digital health partners support access to self-pay populations focused on wellness and preventative healthcare. And international distributors are bringing Galleri to markets outside the U.S. in a capital-efficient manner, with launches in Israel and Canada, and an announced partnership with Samsung in South Korea.
Setting the Performance Bar
Dr. Josh Ofman, Grail's president, emphasized the company's differentiation in the emerging MCED space. Galleri has the highest positive predictive value at 62%, the lowest false positive rate at 0.4%, and accurate cancer signal origin prediction that enables efficient diagnostic workups.
“We have documented well over 100" different cancer types detected, Ofman said, up from the 50 types seen at launch. "Critically, Galleri is the only MCED test that has published validation data in the intended use screening population… and is conducting the largest evidence program ever undertaken for an MCED.”
The company's methylation-based technology was specifically selected for its superior performance and ability to predict where in the body cancer signals originate. Because the test is based on circulating tumor DNA, it preferentially detects aggressive and invasive cancers that shed DNA into the blood, limiting concerns about over-diagnosis of indolent cancers.
Pathfinder 2 Data Shows Promise
In October, Grail presented data from the first 25,000 participants in Pathfinder 2, the largest U.S. MCED study, at ESMO. When Galleri was added to USPSTF A- and B-rated cancer screenings, it yielded a seven-fold increase in cancer detection rate. Adding prostate cancer to those screenings showed a three-fold increase with Galleri.
More than half of Galleri-detected cancers were found in early stages 1 and 2, Ofman said, when cancers are localized and treatments are more effective. Nearly three-quarters of the cancers detected by Galleri have no recommended screening test at all. The episode sensitivity for 12 deadly cancers accounting for about two-thirds of deaths was almost 75%, with no serious study-related adverse events.
The company plans to complete its modular premarket approval filing with FDA in Q1 2026, submitting data from Pathfinder 2 and the prevalent round of the NHS Galleri trial. Mid-year 2026 will bring full datasets from both the 140,000-person NHS Galleri randomized controlled trial and the complete 35,000-participant Pathfinder 2 study.
"It's going to be a very exciting year," Ofman said.
FDA approval would serve as a major trigger for evidence-based coverage decisions with U.S. payers, could enable Medicare coverage, and support expansion in select regulated international markets, Ofman predicts. The company has invested in laboratory infrastructure with one million test capacity per year and the ability to expand substantially over time with moderate capital expenditure.
Grail's new highly automated test process launched at the end of 2024 provides substantial fixed cost leverage, enabling continued price reductions over time as the company scales. The business is positioned to reach gross margins in the 50-60% range at scale.
Looking Beyond Single Cancer Screening
The current cancer screening recommendations cover only five single cancers, detecting just 14% of all incident cancers, while 70-80% of cancer deaths are from cancers with no recommended screening. Grail's vision is that adding Galleri to standard of care screening could identify up to 60% of cancers through screening.
"We don't get to choose the cancer that we get," Ofman said. "We simply have to move away from the model of looking at four or five individual cancers and also begin to look at an individual for whatever cancer you may develop."
Galleri was designed to complement, not replace, existing single cancer screenings like colonoscopy and mammography, Ragusa emphasized, which remain important for detecting precancerous lesions and early-stage disease in their respective organs. Blood-based tests, as yet, have not been shown to detect precancerous lesions from solid tumors, though Galleri does identify pre-malignant hematologic conditions in the blood compartment.
With strong commercial momentum, a clear path to FDA filing, and major data readouts on the horizon, Grail is positioning itself to lead the transformation of population-scale cancer screening in 2026 and beyond.