GRAIL
GRAIL develops multi-cancer early detection technology, including Galleri.
Contents8 sections
Key facts
2016Illumina Spinout
The company traces its origins to cancer-related cell-free DNA found in maternal blood during Illumina prenatal testing in 2015. Illumina spun out GRAIL in 2016 to pursue blood-based cancer detection.[1]
June 2024Spinout and Trading
On June 3, Illumina’s board approved the spinout, planning to distribute 85.5% of GRAIL shares and retain 14.5%. Distribution was expected on June 24 and remained pending at the announcement.[2]
The company’s timeline records that GRAIL began Nasdaq trading as GRAL in June 2024 following Illumina’s board approval of the spinout.[1]
September 23, 2026Regulatory Advice
GRAIL reported advisory-panel votes of 7–2–1 on benefits outweighing risks, 10–0 on safety and 6–4 on effectiveness for Galleri. The recommendation is nonbinding; FDA’s decision remains pending. Josh Ofman was CEO.[3]
Mechanism and Limits
Galleri uses machine learning to analyze methylation in circulating DNA, detect cancer signals and predict their origin. Prescription screening supplements routine screening: positive results require diagnostic confirmation, while negative results cannot rule out cancer. False positives and false negatives occur.[4]
Clinical Research
The company’s evidence program includes case-control validation in CCGA, prospective screening performance in PATHFINDER 2, clinical utility in the randomized NHS-Galleri trial, and prospective real-world research in the Medicare population.[5]
Quality Systems and Laboratories
Related Organizations, Websites, and Public Accounts
GRAIL: Official website: https://grail.com/ (opens in a new window)[7]
Galleri: Official link: https://galleri.com/ (opens in a new window)[4]
X: Public account: https://x.com/grailbio (opens in a new window)[7]
LinkedInLinkedInLinkedIn is a social networking platform for professionals. It was founded in 2002 by Reid Hoffman and others, launched in 2003, and listed on the New York Stock Exchange in 2011; after Microsoft acquired it for approximately $26.2 billion in 2016, it became a wholly owned Microsoft subsidiary. Its revenue comes from membership subscriptions, advertising, and recruitment solutions.Open the full entry: Public profile: https://www.linkedin.com/company/grail-inc./ (opens in a new window)[7]
Sources
- Our Story - GRAIL (opens in a new window)
- Illumina Board of Directors approves spin-off of GRAIL; declares spin-off dividend of GRAIL shares (opens in a new window)
- FDA Advisory Committee Votes In Favor of Approval of GRAIL’s Galleri® Multi-Cancer Early Detection Test (opens in a new window)
- The Galleri Test - GRAIL (opens in a new window)
- Clinical Evidence - GRAIL (opens in a new window)
- Quality and Regulatory - GRAIL (opens in a new window)
- Home - GRAIL (opens in a new window)