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Abbott PCR Test Gets FDA Approval as CDx for Servier's Tibsovo for Rare Blood Cancer

NEW YORK – Abbott's RealTime IDH1 Assay has received approval from the US Food and Drug Administration as a companion diagnostic for Servier Pharmaceuticals' Tibsovo (ivosidenib) in patients with relapsed or refractory myelodysplastic syndrome, the FDA announced on Tuesday. 

The PCR-based test is intended to select patients with isocitrate dehydrogenase-1 mutations for treatment. Tibsovo is the first targeted therapy approved for this indication, the FDA said in a statement, adding that about 3.6 percent of patients with myelodysplastic syndrome have an IDH1 mutation. 

Abbott's test qualitatively detects single nucleotide variants coding five IDH1 R132 mutations in human blood or bone marrow samples, according to the company's website. The assay runs on Abbott's m2000rt system.

Abbott's test previously received FDA approval for use with Tibsovo in patients with relapsed or refractory acute myeloid leukemia with IDH1 mutations.