Grail plan for evaluating its Galleri cancer liquid biopsy challenged- STAT

A new analysis published Sunday challenges the clinical trial endpoint the cancer screening firm Grail is using to evaluate its blood test aimed at simultaneously detecting multiple types of tumors early.

Grail’s test, called Galleri, is available in the U.S. but not yet approved by the Food and Drug Administration or reimbursed by Medicare except as part of a particular clinical trial. According to reports from the DNA sequencing giant Illumina, which currently owns Grail but is planning to divest it, Grail generated $30 million in revenue in the fourth quarter of 2023, a period when it lost $197 million.

If Galleri works, a single blood test that could screen for many types of cancers, called a multi-cancer early detection (MCED) test, could represent a gigantic win for public health.