Abbott's PCR-Based Companion Diagnostic Receives FDA Approval for Servier's Tibsovo in Rare Blood Cancer

On October 24, the U.S. Food and Drug Administration (FDA) announced that Abbott's RealTime IDH1 Assay has received FDA approval as a companion diagnostic for Servier Pharmaceuticals' Tibsovo (ivosidenib) to treat patients with relapsed or refractory myelodysplastic syndromes.

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

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

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

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