COMPANY:

Abbott

"Oral aza/ven is a regimen currently being investigated for the treatment of ND and R/R AML. High response rates have been seen in the newly-diagnosed cohort with 9 achieving a CR/CRi, including 4/5 who harbor a TP53 mutation. Final results with genomic annotation, as well as further translational studies exploring mechanistic insights will be presented."

"Abbott...has received U.S. Food and Drug Administration (FDA) approval for its molecular human papillomavirus or HPV screening solution, adding a powerful cancer screening tool for detecting high-risk HPV infections to the Alinity m family of diagnostic assays...The Alinity m high risk (HR) HPV assay is approved as a test for HPV detection and for use in routine cervical cancer screening as per professional medical guidelines."

"...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."

"...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."