FDA Guardant Health
The US Food and Drug Administration has approved a blood test to be used for colorectal cancer screening among average-risk adults 45 and older.
The maker of the test, Palo Alto, California-based biotechnology company Guardant Health, announced Monday that this is the first blood test to be approved by the FDA as a primary screening option for colorectal cancer, and it’s the first approved blood screening test for colorectal cancer that meets requirements for Medicare reimbursement. For patients with commercial insurance plans, the cost of the test may vary depending on their individual plan coverage. The list price for the test has not yet been announced.
Die Vorstudie von Epigenomics brachte mit ihrem neuen Test NrxtGen die gleichen Werte wie Guardant Health, die bekommen jetzt Zulassung und Erstattung. NDD sollte sich nicht zu lange Zeit lassen mit der Hauptstudie.
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