Grail

GRAIL, Inc. is an American biotechnology company headquartered at 1525 O'Brien Drive, Menlo Park, California, founded in 2015 as a startup subsidiary of DNA sequencing maker Illumina. The company develops blood-based cancer screening, most notably the Galleri multi-cancer early detection (MCED) test, which analyzes circulating cell-free DNA using targeted methylation sequencing, next-generation sequencing and machine learning classifiers to identify a shared cancer signal across more than 50 cancer types and to predict the likely cancer signal origin for positive results. GRAIL states the test is intended to screen for cancers before they become symptomatic, including cancers without recommended screening tests today, and notes that it does not detect a signal for all cancers and that false positive and false negative results occur.

Beyond Galleri, company profiles list a diagnostic aid for cancer (DAC) blood test intended to speed diagnostic resolution in patients presenting with non-specific signs and symptoms and clinical suspicion of cancer, research-use-only liquid biopsy assays for biopharma clinical research, an external sponsored research program supporting investigator-sponsored trials and collaborations, and provider ordering/workflow integration services. Stated expertise spans cfDNA analysis, methylation assay development, machine-learning diagnostic classifiers, clinical study design, CLIA/CAP laboratory operations and large-scale genomic data engineering; the company holds numerous granted U.S. patents covering methylation sequencing library preparation, contamination detection, and cancer classification methods. GRAIL also maintains a public GitHub organization with open-source Go and Bazel tooling for distributed data processing and bioinformatics, including reflow, bigslice, bigmachine and bio.

As a corporate entity, GRAIL was spun out of Illumina in 2016, reacquired by Illumina in 2021, then divested again following EU and U.S. antitrust intervention, completing a Nasdaq spin-off (ticker GRAL) in June 2024 with Illumina retaining a 14.5% stake. The company reported 2024 revenue of about US$126 million, an operating loss of about US$2.2 billion, a net loss of about US$2.0 billion, total assets of about US$2.98 billion and roughly 1,000 employees.

Founding story

GRAIL was founded in 2015 as a startup subsidiary of Illumina, the San Diego DNA sequencing manufacturer, based on Illumina research showing that repeated sequencing of DNA in the bloodstream could more accurately detect DNA fragments shed by cancer cells. Richard Klausner, then Illumina's chief medical officer and a former director of the National Cancer Institute, advocated for creating the business and joined GRAIL's board. The company was initially headed by Jeffrey Huber; profile data also lists Alex Aravanis and Jessica Owens among founders.

Business model

GRAIL commercializes laboratory-based cancer screening tests, primarily the Galleri MCED test, which it launched in the United States in mid-2021 as a laboratory developed test and has sold more than 215,000 commercial tests. It also engages in biopharmaceutical partnerships and provides research-use-only liquid biopsy assays for clinical research, and collaborates with health systems and academic centers, including a commercial partnership with NHS England to trial Galleri. Profile listings describe the model as B2B healthcare solutions.

Revenue derives from sales of its blood-based tests to providers, health systems and other purchasers (including employer/organization-sponsored programs such as a fire department offering testing to employees) and from biopharma partnerships. Reported revenue was approximately US$32 million in Q2 2024 (up 43% year over year) and US$126 million for full-year 2024.

Traction

More than 215,000 commercial Galleri tests sold since the mid-2021 U.S. launch. Full-year 2024 revenue of about US$126 million; Q2 2024 revenue of nearly US$32 million, up 43% year over year. The company reported positive top-line results from the PATHFINDER 2 registrational study and announced an FDA advisory committee meeting to review its premarket approval application for Galleri (August 2026). Recognitions include Fortune's Change the World list, TIME's Best Inventions of 2022 for Galleri, and "Best Overall Medical Device Company" in the 2022 MedTech Breakthrough Awards.

Latest developments

In August 2024 GRAIL announced a restructuring eliminating roughly 350 positions (25% of its June 30 workforce, or 30% including planned 2024 hires) to refocus on Galleri and extend cash runway from the second half of 2026 into 2028, substantially reducing R&D investment in programs beyond Galleri such as the diagnostic aid for cancer and minimal residual disease while continuing biopharma partnerships. The company subsequently reported positive top-line results from the PATHFINDER 2 registrational study, which as of October 2025 had not yet been peer reviewed or published; BBC coverage in October 2025 followed results presented at the European Society for Medical Oncology. On August 7, 2026, GRAIL announced an FDA advisory committee meeting to review its premarket approval application for Galleri, and it reported second quarter 2026 financial results on August 5, 2026. Company-profile data as of August 2026 lists a $3.5 billion market capitalization, a share price of $77.97, 910 employees, FY2025 revenue of $147.2 million, and active hiring across engineering and data/ML roles.