"Challenges to Grail's Galleri Cancer Liquid Biopsy Evaluation Plan"
WHO scientists are questioning the clinical trial endpoint being used by Grail to evaluate its Galleri blood test, which aims to detect multiple types of tumors early. The test is currently available in the U.S. but not yet approved by the FDA or reimbursed by Medicare, and Grail generated $30 million in revenue in the fourth quarter of 2023 while incurring a $197 million loss. If successful, the Galleri test could revolutionize cancer screening as a multi-cancer early detection test, but concerns about its evaluation process persist.