Grail (company)

GRAIL, Inc.

Company type	Public
Industry	Biotechnology
Founded	January 1, 2015 (2015-01-01) in San Francisco, California, United States
Founder	Richard Klausner
Headquarters	Menlo Park , United States
Area served	Worldwide
Products	Galleri test (liquid biopsy for early cancer detection)
Owner	Public company; Illumina retains 14.5% ownership
Parent	None (formerly a subsidiary of Illumina until 2024)
Website	www.grail.com

GRAIL, Inc. is a biotechnology firm headquartered in Menlo Park, California, established in 2015 with the purpose of creating early detection tests for cancer in individuals without symptoms. Originally operating as a subsidiary of Illumina, the parent company fully acquired GRAIL in 2021.

In June 2021, GRAIL introduced the Galleri test, a liquid biopsy designed for early identification of multiple cancer types. Following regulatory directives from the European Union, GRAIL was separated from Illumina, finalizing this divestiture on June 24, 2024.

Activities

Research conducted by Illumina demonstrated that conducting repeated sequencing on circulating DNA enhances the ability to detect fragments originating from cancer. To develop the comprehensive datasets necessary for recognizing and analyzing cancer biomarkers, GRAIL planned to recruit more than 100,000 participants into clinical studies.

Galleri test

By November 2020, Galleri had been evaluated through three different multi-cancer screening assessments. The Galleri test was officially launched by GRAIL in June 2021 as a liquid biopsy aimed at detecting multiple cancers early (MCED). Marketed as a "revolutionary and potentially life-saving innovation," initial trial outcomes were underwhelming. A significant trial conducted by NHS England attracted criticism for excessive promotion and ethical concerns. By 2024, GRAIL faced dissatisfaction among investors alongside various legal disputes.

A June 2025 article in The New Yorker explored the test’s adaptability potential amid ongoing clinical investigations. On October 18, 2025, the BBC reported encouraging findings presented at the European Society for Medical Oncology; nevertheless, as of October 20, results from the PATHFINDER 2 study have neither been published nor subjected to peer review. Eric Topol highlighted a sensitivity rate of only 40%, noting that false negatives failed to detect cancers that developed during a twelve-month follow-up period.

Company history

Founded in San Francisco in 2015 as a startup focused on biotechnology and pharmaceuticals, GRAIL initially received support from Illumina, based in San Diego and known for manufacturing DNA sequencing equipment used in human biology and genetic disease diagnostics. Richard Klausner—then Illumina’s chief medical officer and former director of the National Cancer Institute—was instrumental in founding GRAIL, envisioning the use of DNA sequencing to identify tumors through blood tests. Klausner also served on GRAIL’s board. By 2017, Illumina held a 20% stake in GRAIL’s profits.

In September 2020, Illumina agreed to acquire GRAIL entirely for $7.1 billion. Later that year, GRAIL collaborated with the UK’s National Health Service (NHS) to conduct trials of its Galleri blood test for early cancer detection, with results anticipated in 2026.

The U.S. Federal Trade Commission (FTC) filed a lawsuit in March 2021 aiming to block the acquisition on antitrust grounds; however, an administrative judge ruled against the FTC in September 2022.

In June 2023, GRAIL revealed that due to a software configuration error by an external vendor—not due to faults in the test itself—408 patients were mistakenly informed they might have cancer.

By July 2023, three former female employees initiated legal actions alleging a hostile workplace and inappropriate corporate culture within GRAIL.

In October 2023, the European Commission mandated that Illumina divest GRAIL within one year over antitrust concerns. Approval for Illumina’s divestiture strategy was granted by the European Commission in April 2024, permitting either a trade sale or capital markets transaction (spin-off). In May 2024, Illumina submitted a Form 10 registration statement with the SEC as part of the spin-off process and pledged approximately $1 billion to support GRAIL’s operations for two and a half years following separation.

The spin-off was finalized in June 2024, with GRAIL becoming publicly listed on Nasdaq under the ticker symbol GRAL. Illumina retained a minority ownership of 14.5% in the company.