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

Grail, a cancer screening firm, is using a blood test called Galleri to detect multiple types of tumors early. However, the clinical trial endpoint for this test is being challenged. The test is available in the U.S. but not approved by the FDA or reimbursed by Medicare, except for specific clinical trials. Owned by Illumina, Grail generated $30 million in revenue but lost $197 million in the fourth quarter of 2023. If Galleri is successful, it could revolutionize cancer screening by offering a single blood test for multiple types of cancers, known as a multi-cancer early detection (MCED) test, benefiting public health.

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