GRAIL
Menlo Park, California, United States
GRAIL is a healthcare company dedicated to the early detection of cancer through innovative blood-based tests. Their multi-cancer early detection (MCED) platform, including the Galleri test, aims to detect over 50 types of cancer early when it is more treatable and potentially curable.
How We Help
Problem Statement
The problem GRAIL solves is the late detection of many deadly cancers that lack routine screening methods, leading to less effective treatments and lower survival rates. They provide a solution for early cancer detection before symptoms arise.
Core Technology
Multi-cancer early detection platform utilizing next-generation sequencing (NGS), ultra-deep sequencing of cell-free DNA (cfDNA), machine learning and artificial intelligence, and a targeted methylation-based platform.
Key Differentiators
Multi-Cancer Early Detection (MCED) from a single blood draw, robust clinical validation (large-scale studies like CCGA, NHS-Galleri, PATHFINDER, SYMPLIFY), high accuracy and low false positive rate (99.5% specificity), advanced technology integration, patient-centric approach, population-scale strategy, and comprehensive care continuum support.
Clinical Focus
Early detection of cancer, specifically multiple deadly cancer types, before symptoms arise, with the Galleri test capable of detecting over 50 types of cancer.
Target Customers
Healthcare providers (who order the test), healthcare systems, Medicare Advantage plans, and biopharmaceutical companies (for research-use-only technology).
Product Stage
GA
Company Info
- Business Model
- Developing and commercializing multi-cancer early detection (MCED) blood tests, primarily the prescription-based Galleri test, generating revenue through sales and partnerships with healthcare systems/Medicare Advantage plans. They also offer a research-use-only (RUO) technology solution for biopharmaceutical companies.
- Founded
- 2016
- Total Funding
- 3,220,000,000
- Website
- www.grail.com
Categories
Disease Areas
Technologies
Clinical & IP
Clinical Validation
The Galleri test was designated as a 'Breakthrough Device' by the FDA in 2018. GRAIL submitted the final module of its Premarket Approval (PMA) application to the FDA on January 29, 2026. It is currently available in the U.S. as a 'laboratory developed test' (LDT) under CLIA regulations. Robust clinical validation includes large-scale studies such as CCGA, NHS-Galleri, PATHFINDER, and SYMPLIFY. An FDA-approved Investigational Device Exemption (IDE) study was initiated in November 2023. The test demonstrates high specificity of 99.5% and high accuracy (93.4% or 92%) in predicting cancer signal origin.
MedStartr Index Score
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