Grail's Multi-Cancer Blood Test Gets FDA Committee Vote for Premarket Approval
The Wall Street Journal
Grail received a favorable vote from an FDA panel for premarket approval of its multi-cancer early detection blood test. The FDA advisory committee vote was favorable ahead of premarket approval review. The next step is the FDA’s decision on whether to approve the test for use.
Why it matters
Grail has received a favorable vote from an FDA panel regarding premarket approval for its multi-cancer early detection test. The test is designed to detect cancer-specific methylation patterns and predict the cancer signal origin with high accuracy.