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    1year
    Incorporation of Parameters to Corroborate Variant Calling by a Proprietary Algorithm for an IDH1/2 PCR Assay (AMP 2023)
    A false negative result prompted a detailed examination of data used in the proprietary algorithm for the IDH1/2 PCR assay for variant calling. This led to a new workflow incorporating Ct and MR cutoffs to trigger repeat testing, which significantly reduces the likelihood of false negative results in the future.
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH1 mutation
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    Abbott RealTime IDH1
    1year
    FDA approves new therapy for rare form of blood cancers called myelodysplastic syndromes (FDA)
    "...U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. This is the first targeted therapy approved for this indication. The agency also approved the Abbott RealTime IDH1 Assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation."
    FDA event
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    Abbott RealTime IDH1
    almost2years
    FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation (FDA)
    "...Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test...FDA also approved the Abbott RealTime IDH1 Assay to select patients for olutasidenib."
    FDA event
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    Abbott RealTime IDH1