Blood
Abbott Gets FDA Approval for Blood Cancer Companion Diagnostic
Oct
By Ben Glickman
Abbott Laboratories’ diagnostic for patients with a rare form of blood cancer was approved by the U.S. Food and Drug Administration.
The FDA approved the RealTime IDH1 Assay as a companion diagnostic for the selection of relapsed or refractory myelodysplastic syndromes with a mutation in isocitrate dehydrogenase-1.
The FDA said MDS, a form of blood cancer, can be caused by mutations in bone marrow cells.
The FDA also approved Tibsovo for the treatment of adult patients with the same form of MDS, the first targeted therapy approved for the indication.
Tibsovo was previously approved for some adults with acute myeloid leukemia and cholangiocarcinoma.
Abbott’s test was previously approved as a companion diagnostic to identify AML patients with the same genetic mutation for treatment with Tibsovo or Rezlidhia.
Write to Ben Glickman at [email protected]
