FDA awards breakthrough device status to sickle cell diagnostic test
✦ NabkaNews BriefAuto-summarized from multiple outlets · verify with the source
A diagnostic test for sickle cell disease has been awarded breakthrough device status by the FDA. However, reports vary on the specifics of the designation, with some indicating it was for a gene-edited cell therapy, while another outlet mentions a different condition, hypertension, and a separate company receiving funding for a different test. The details of the FDA's designation and the test or therapy involved are not entirely clear.