Home / Health / FDA Staff Back Grail's Cancer Blood Test
FDA Staff Back Grail's Cancer Blood Test
21 Sep
Summary
- FDA reviewers found no major safety concerns with Grail's blood test.
- The test, called Galleri, can detect over 50 types of cancer.
- Grail's shares surged 35% following the positive FDA staff findings.
US FDA staff reviewers have not raised significant concerns about the accuracy and safety of Grail's Galleri blood test, designed to detect more than 50 cancers. This news caused Grail's shares to surge by 35% on Monday.
The Galleri test's findings will be evaluated by FDA external advisors this Wednesday, as Grail seeks premarket approval. The FDA has no outstanding questions regarding the test's analytical performance or primary safety analyses.
However, the agency has asked advisors to discuss whether evidence supports characterizing Galleri as an 'early detection' test. Grail's shares had previously fallen over 20% in February after a UK trial indicated routine screening did not significantly improve early detection.
Grail filed for FDA approval in January based on data from a smaller US trial and a UK trial. Galleri and Abbott Laboratories' Cancerguard are available under CLIA regulations but lack FDA approval. FDA approval would facilitate wider distribution and insurance coverage.
