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GRAIL
GRAIL develops blood tests for early cancer detection; its Galleri multi-cancer early detection test is sold in the U.S. as a laboratory-developed test and is not FDA-approved. A premarket approval application for Galleri is under FDA review, and the company became independent from Illumina in 2024.
Verified highlights each with its source
- GRAIL submitted a premarket approval (PMA) application for Galleri on Jan. 29, 2026, supported by the PATHFINDER 2 (NCT05155605) and NHS-Galleri (NCT05611632) studies (company release).
Source: grail.com ↗ - On Sept. 23, 2026, an FDA advisory panel voted 7–2 (one abstention) that Galleri's benefits outweigh its risks; the FDA has not yet issued a decision.
Source: grail.com ↗ - GRAIL was spun off from Illumina on June 24, 2024.
Source: en.wikipedia.org ↗
Sources
Science and stocks are different questions. This profile describes scientific and regulatory progress. It says nothing about whether the company’s shares will rise or fall, and it is not a recommendation to buy, sell or hold any security.
Disclosure. Spin Pharma has no financial relationship with this company and holds no position in it.
