COMPREHENSIVE CLINICAL EVALUATION OF THE EXENT ANALYZER FOR DETECTION AND CHARACTERIZATION OF MONOCLONAL GAMMOPATHIES

@article{pauli2026comprehensive,
  title = {{COMPREHENSIVE CLINICAL EVALUATION OF THE EXENT ANALYZER FOR DETECTION AND CHARACTERIZATION OF MONOCLONAL GAMMOPATHIES}},
  author = {Jill PAULI and Nick PACIARONI and Syreeta ALLEN and Gemma MALIN and Cristina SIMION and Alex BREAN and Habib EL-KHOURY and Julia COLCHIE and Luca BERTAMINI and Erica M HOROWITZ and Irene GHOBRIAL and Grace FLEMING and Zianya M SOLIS and Kaleb Benjamin MCLENDON and John J ROBACK and Andrew S NEISH and Sarah K GREWAL and Ashutosh WECHALEKAR and David M FOUCAUD and Manisha BUTHANI and Nohemi CABALLERO and Maria Florencia DELGADO and Elyara Maria SOARES and Oscar BERLANGA and Stephen HARDING},
  journal = {Hematology, Transfusion and Cell Therapy},
  year = {2026},
  month = oct,
  doi = {10.1016/j.htct.2026.107855},
  url = {https://doi.org/10.1016/j.htct.2026.107855},
  note = {CC BY},
}

TY  - JOUR
TI  - COMPREHENSIVE CLINICAL EVALUATION OF THE EXENT ANALYZER FOR DETECTION AND CHARACTERIZATION OF MONOCLONAL GAMMOPATHIES
AU  - Jill PAULI
AU  - Nick PACIARONI
AU  - Syreeta ALLEN
AU  - Gemma MALIN
AU  - Cristina SIMION
AU  - Alex BREAN
AU  - Habib EL-KHOURY
AU  - Julia COLCHIE
AU  - Luca BERTAMINI
AU  - Erica M HOROWITZ
AU  - Irene GHOBRIAL
AU  - Grace FLEMING
AU  - Zianya M SOLIS
AU  - Kaleb Benjamin MCLENDON
AU  - John J ROBACK
AU  - Andrew S NEISH
AU  - Sarah K GREWAL
AU  - Ashutosh WECHALEKAR
AU  - David M FOUCAUD
AU  - Manisha BUTHANI
AU  - Nohemi CABALLERO
AU  - Maria Florencia DELGADO
AU  - Elyara Maria SOARES
AU  - Oscar BERLANGA
AU  - Stephen HARDING
PY  - 2026
DA  - 2026/10/23
JO  - Hematology, Transfusion and Cell Therapy
DO  - 10.1016/j.htct.2026.107855
UR  - https://doi.org/10.1016/j.htct.2026.107855
AB  - Background: Accurate detection and characterization of serum monoclonal proteins are essential for the diagnosis and management of monoclonal gammopathies. The Immunoglobulin Isotypes (GAM) assay on the EXENTTM Analyzer (The Binding Site, part of Thermo Fisher Scientific) [henceforth described as the EXENT GAM assay] uses mass spectrometry to detect, isotype, and quantify intact monoclonal immunoglobulins in a single workflow. We evaluated the clinical performance of the EXENT analyser across a broad spectrum of monoclonal gammopathies. Methods: Residual serum samples were analyzed at three independent centers. The study included patients with clinically confirmed IgG, IgA, or IgM monoclonal gammopathies, disease controls, healthy subjects, and a cross-reactivity cohort. Patients with light chain-only and IgD monoclonal gammopathies were excluded. EXENT analyzer results were compared with clinical diagnosis and with conventional serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE). A positive EXENT analyzer result was defined as detection of an intact IgG, IgA, or IgM M-protein at or above the FDA-cleared isotype-specific diagnostic cut-offs (IgG ≥0.359 g/L, IgA ≥0.325 g/L, and IgM ≥0.197 g/L). Results below these thresholds were classified as negative. Diagnostic sensitivity and specificity were determined, while agreement with conventional testing was assessed for M-protein detection, isotype assignment, and quantification. Results: Among 688 patients with monoclonal gammopathies, the EXENT GAM assay demonstrated an overall diagnostic sensitivity of 94.3% (95% CI, 92.3–95.8), including 92.1% for MGUS, 98.6% for smouldering MM, 94.4% for MM, 98.4% for Waldenström macroglobulinemia, and 89.6% for AL amyloidosis. Diagnostic specificity was 87.8% (95% CI, 85.1–90.1) in 655 disease controls. Overall positivity was comparable to SPE (94.3% vs 93.5%) and higher in AL amyloidosis (89.6% vs 80.5%). EXENT showed 95.3% concordance with IFE for isotype assignment and good quantitative agreement with SPE for IgG and IgA monoclonal proteins. As expected, IgM quantification showed a positive bias relative to SPE because of methodological differences between total immunoglobulin measurement and densitometry. Conclusion: The EXENT GAM assay demonstrated high clinical sensitivity for detecting intact IgG, IgA, and IgM monoclonal gammopathies across multiple disease settings while providing accurate isotype characterization and quantitative assessment.
SN  - 2531-1379
SN  - 2531-1387
ER  -