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IV

ivosidenib

✓ Approved

Agios Pharmaceuticals, Inc. · Companion diagnostic · Companion diagnostic

What is ivosidenib?

ivosidenib is a companion diagnostic developed by Agios Pharmaceuticals, Inc.. It is approved for therapeutic indications via others.

Drug Profile

CompanyAgios Pharmaceuticals, Inc.
Drug ClassCompanion diagnostic
RouteOthers
StatusApproved

Therapeutic Indications

ivosidenib is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancer✓ Approved

Related Research Articles

PubMedMedicine2026-09-19

Development and validation of a blood-based diagnostic model for pulmonary tuberculosis combining GBP5 expression and routine laboratory indicators.

Zhao Miaomiao M, Hu Qiuxiang Q, Wang Qing Q, Cha Xinlang X et al.

WHO reports that only 54% of tuberculosis (TB) patients received rapid diagnostic tests at their initial presentation. Conventional laboratory methods in TB detection have high specificity (>90%) but low sensitivity (<50%). This means a large number of tuberculosis patients are missed. A better diagnostic approach is essential to decrease the TB burden. Studies on multi-indicator blood-based models for rapid TB diagnosis remain limited. We developed a rapid, non-sputum-based model to improve the efficiency of TB diagnosis. This was a retrospective case-control study including 301 patients with active tuberculosis (ATB) and 191 patients with other pulmonary diseases (OPD) who were evaluated at the Department of Pulmonary Medicine of the Affiliated Infectious Diseases Hospital of Soochow University between May 2023 and May 2024. A composite clinical diagnosis served as the gold standard for ATB diagnosis, including either a clinical diagnosis or bacteriological confirmation. The diagnostic outcome of ATB (ATB vs OPD) was defined as the dependent variable, while guanylate-binding protein 5 (GBP5) expression levels and routine laboratory indicators (including blood cell counts and plasma protein measurements) were defined as independent variables. Univariate and multivariate logistic regression analyses were performed to identify key predictors, and an AdaBoost algorithm was used to construct a TB diagnostic model. The performance of the model was compared with traditional laboratory-based TB tests. DeLong's Test was used to evaluate the statistical difference of AUC between AdaBoost and traditional methods. Through univariate and multivariate logistic regression analyses, the GBP5 gene, white blood cell (WBC) count, platelet (PLT) count, and prothrombin time (PT) were selected to construct an ATB diagnosis model using the AdaBoost algorithm. The AdaBoost model achieved an AUC of 0.808 in the training set and 0.805 in the test set, while the AUC of smear microscopy, MTB culture, Xpert MTB/RIF, and IGRA were 0.67, 0.59, 0.63 and 0.75 respectively. Therefore, our model demonstrated better diagnostic performance than conventional methods. This study preliminarily demonstrates that our AdaBoost diagnostic model based on GBP5 gene expression and routine blood indicators could serve as a potential tool for the clinical diagnosis of ATB. However, to be applied to the clinic, large samples are needed to validate the performance of the model.

PubMedJournal of the European Academy of Dermatology and Venereology : JEADV2026-09-19

From diagnostic accuracy to clinical utility in molecular dermatopathology.

Yılmaz Ercan E, Özer Nezihe Koker NK, Topal Erdem E

PubMedInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2026-09-19

Response: Diagnostic utility of APRI, FIB-4, and FIB-5 in intrahepatic cholestasis of pregnancy.

Cicek Sevil S, Kapudere Bilge B, Kaya Parspancı Yasemin Beyza YB, Tavukcuoglu Zehra Z et al.

PubMedJournal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine2026-09-19

From Diagnostic Accuracy to Clinical Utility: Methodological Considerations on Contrast-Enhanced Ultrasono-Distal Cologram in Anorectal Malformations.

Gu Jiawei J, Shao Jie J

PubMedInsights into imaging2026-09-19

Intracranial venous thrombosis imaging by anatomical location: an educational review with mimics and diagnostic pitfalls.

Delgado Anna Falk AF, Fällmar David D, Martin Heather H, Mazya Michael V MV et al.

Intracranial venous thrombosis encompasses diverse etiologies with clinical presentations ranging from an incidental finding to coma and death. Despite potentially devastating consequences, venous thrombosis is frequently overlooked by radiologists due to its predominantly extraaxial location close to the skull and clinical emphasis on arterial imaging evaluation in acute stroke management. This educational review addresses common and uncommon presentations across all anatomical locations of intracranial venous thrombosis, providing practical pearls and pitfalls for diagnostic interpretation. We review the imaging modalities CT and MRI, together with their venographic techniques, correlating imaging findings with anatomical location, thrombus age and signal evolution, complications, and underlying causes. Critical interpretive pitfalls are highlighted with strategies to avoid misdiagnosis. The review also emphasizes the important yet underrecognized association between intracranial pressure disorders and venous thrombosis, providing radiologists with a practical framework for improved diagnostic accuracy. KEY POINTS: Question How can radiologists systematically recognize intracranial venous thrombosis across all anatomical locations and avoid the diagnostic pitfalls that lead to clinically significant missed diagnoses? Findings Location-specific imaging patterns, thrombus signal evolution, and recognition of common mimics such as arachnoid granulations enable accurate detection using combined non-contrast and venographic sequences. Critical relevance statement By organizing intracranial venous thrombosis imaging anatomically and pairing each location with its specific mimics and pitfalls, this review equips radiologists with a practical framework to improve detection accuracy and prevent clinically significant missed diagnoses.

PubMedMedicine2026-09-19

Reveal the diagnostic value of a neutrophil inflammation- and cell death-associated gene signature in rheumatoid arthritis.

Gu Chunsong C, Chen Yujia Y, Huang Wei W, Chai Yihui Y et al.

This study aimed to construct an artificial neural network (ANN) diagnostic model for rheumatoid arthritis (RA) based on a neutrophil inflammation- and cell death-associated gene signature derived from a previously reported neutrophil extracellular traps (NETs)-related gene set, and to explore its association with immune infiltration and inflammatory pathways. The GEO dataset GSE110169 was used as the training dataset to identify differentially expressed genes between RA patients and healthy controls. Genes derived from a previously published NETs-related gene set were used as the initial candidate genes. Candidate genes were further screened using a random forest algorithm, and an ANN diagnostic model was constructed using the selected feature genes. Model performance was assessed by 10-fold cross-validation and externally validated in GSE93272. Cell Type Identification By Estimating Relative Samples Of RNA Transcripts was used to estimate immune infiltration, and weighted gene co-expression network analysis, gene ontology, and Kyoto encyclopedia of genes and genomes analyses were performed to explore related biological functions. Eleven selected feature genes were retained for model construction: Wiskott-Aldrich syndrome protein-like actin nucleation promoting factor, MFN1, enolase-1, optic atrophy 1, CLEC7A, interleukin-8, S100A8, ACTN4, RIPK1, CASP1, and integrin-linked kinase. The ANN model achieved an area under the curve of 0.923 in the training dataset and 0.722 in the external validation dataset. Immune infiltration analysis suggested that these genes were associated with gamma delta T cells, macrophages M0, memory B cells, resting dendritic cells, and activated dendritic cells. Functional enrichment analysis indicated involvement in lysosome, osteoclast differentiation, hematopoietic cell lineage, chemokine signaling pathway, and Fc gamma R-mediated phagocytosis. This study developed an ANN diagnostic model based on an neutrophil inflammation- and cell death-associated gene signature with potential diagnostic value for RA. However, because direct NET markers were not experimentally evaluated, the selected genes should not be interpreted as NETs-specific biomarkers. Further experimental validation is required.

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