Long after the rise and fall of Theranos, the potential of powerful diagnostic information obtained from a single blood draw has once again captured much attention. The Galleri blood test can detect as many as 50 different types of cancer and is now being offered in various settings. Although some experts are enthusiastically calling it a game-changer, some questions have arisen about its use. Having a blood test for multiple cancers is a "very good idea and the scientific basis for this platform is sound," said Timothy R. Rebbeck, PhD. "But the devil is in the details to ensure the test can accurately detect very early cancers and there is a pathway for subsequent workup (diagnosis, monitoring, treatment, etc)." The test uses cell-free DNA (cfDNA) sequencing and has an overall sensitivity for any stage of cancer of 51.5%. Sensitivity was better for later-stage cancers (77% for stage III and 90.1% for stage IV) and lower for early-stage cancers (16.8% for stage I and 40.4% for stage II). Galleri is offering the test to patients older than 50 years who have a family history of cancer, as well as those who are high risk for cancer or immunocompromised. A prescription is required, and patients must pay for it out of pocket (around $950). It is not covered by medical insurance and is not approved by the FDA.
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