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Article

Evaluation of the Idylla IDH1-2 Mutation Assay for the Detection of IDH Variants in Solid Tumors and Hematological Malignancies

by
Pauline Gilson
1,2,*,
Marc Muller
2,3,
Guillaume Gauchotte
4,5,
Smahane Fadil
2,
Marie Husson
1,2,
Idrissia Hanriot
2,
Andréa Witz
2,
Julie Dardare
2,
Margaux Betz
1,2,
Jean-Louis Merlin
1,2 and
Alexandre Harlé
1,2
1
Institut de Cancérologie de Lorraine, Centre National de la Recherche Scientifique (CNRS) Unité Mixte de Recherche 7039 (UMR 7039), Université de Lorraine, 6 Avenue de Bourgogne, CS 30519, 54519 Vandœuvre-lès-Nancy, France
2
Service de Biologie Moléculaire des Tumeurs, Département de Biopathologie, Institut de Cancérologie de Lorraine/CHRU Nancy, Rue du Morvan, 54511 Vandœuvre-lès-Nancy, France
3
Laboratoire de Génétique, Centre Hospitalier Universitaire Nancy, Rue du Morvan, 54511 Vandœuvre-lès-Nancy, France
4
Service d’Anatomie et Cytologie Pathologiques, Tumorothèque BB-0033-00035, Département de Biopathologie, Institut de Cancérologie de Lorraine/CHRU Nancy, Rue du Morvan, 54511 Vandœuvre-lès-Nancy, France
5
INSERM U1256 NGERE, Université de Lorraine, 54500 Vandœuvre-lès-Nancy, France
*
Author to whom correspondence should be addressed.
Int. J. Mol. Sci. 2026, 27(2), 1017; https://doi.org/10.3390/ijms27021017
Submission received: 3 December 2025 / Revised: 9 January 2026 / Accepted: 16 January 2026 / Published: 20 January 2026
(This article belongs to the Section Molecular Biology)
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Abstract

Isocitrate dehydrogenase (IDH) variants can lead to the development and/or progression of various solid tumors and hematological malignancies. IDH testing can guide diagnosis, prognosis, and therapeutic choice and typically relies on NGS, IHC, or PCR-based assays. Here, we evaluated the analytical performance of the Idylla IDH1-2 mutation assay for IDH variant detection using 70 fixed samples from patients with solid tumors and 36 DNA extracts from patients with acute myeloid leukemias previously characterized by NGS +/− IHC. Idylla IDH1-2 mutation assay gave 98.1% of valid results with an overall agreement, sensitivity, and specificity of 97.1%, 96.2%, and 98.1%, respectively, compared to NGS. Using commercial DNA standards, the limit of detection of the assay was 1.6% and 0.5% for IDH1 R132H and IDH2 R172K variants, respectively. Based on these data, the Idylla IDH1-2 mutation assay represents a fast and reliable alternative to detect IDH hotspot variants in solid tumors and hematological malignancies using either fixed tissue sections or DNA extracts. Particular attention, however, is needed for the interpretation of cases with cycle of quantification values of the internal controls over 35, for which a variant with low allelic frequency could be missed due to low DNA quantity or quality.
Keywords: isocitrate dehydrogenase; polymerase chain reaction; immunohistochemistry; next-generation sequencing isocitrate dehydrogenase; polymerase chain reaction; immunohistochemistry; next-generation sequencing

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MDPI and ACS Style

Gilson, P.; Muller, M.; Gauchotte, G.; Fadil, S.; Husson, M.; Hanriot, I.; Witz, A.; Dardare, J.; Betz, M.; Merlin, J.-L.; et al. Evaluation of the Idylla IDH1-2 Mutation Assay for the Detection of IDH Variants in Solid Tumors and Hematological Malignancies. Int. J. Mol. Sci. 2026, 27, 1017. https://doi.org/10.3390/ijms27021017

AMA Style

Gilson P, Muller M, Gauchotte G, Fadil S, Husson M, Hanriot I, Witz A, Dardare J, Betz M, Merlin J-L, et al. Evaluation of the Idylla IDH1-2 Mutation Assay for the Detection of IDH Variants in Solid Tumors and Hematological Malignancies. International Journal of Molecular Sciences. 2026; 27(2):1017. https://doi.org/10.3390/ijms27021017

Chicago/Turabian Style

Gilson, Pauline, Marc Muller, Guillaume Gauchotte, Smahane Fadil, Marie Husson, Idrissia Hanriot, Andréa Witz, Julie Dardare, Margaux Betz, Jean-Louis Merlin, and et al. 2026. "Evaluation of the Idylla IDH1-2 Mutation Assay for the Detection of IDH Variants in Solid Tumors and Hematological Malignancies" International Journal of Molecular Sciences 27, no. 2: 1017. https://doi.org/10.3390/ijms27021017

APA Style

Gilson, P., Muller, M., Gauchotte, G., Fadil, S., Husson, M., Hanriot, I., Witz, A., Dardare, J., Betz, M., Merlin, J.-L., & Harlé, A. (2026). Evaluation of the Idylla IDH1-2 Mutation Assay for the Detection of IDH Variants in Solid Tumors and Hematological Malignancies. International Journal of Molecular Sciences, 27(2), 1017. https://doi.org/10.3390/ijms27021017

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