Clinical authorization of EXENT System expands to Australia
Waltham, MASS – Thermo Fisher Scientific Receives authorization for sale for the EXENT® System* in Australia**, Enhancing the Assessment of Patients with Monoclonal Gammopathies
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Website: https://www.thermofisher.com/bindingsite/gb/en/products/instruments/exent-system.html.
About Thermo Fisher Scientific
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References
1. Giles HV, et al. Redefining nonmeasurable multiple myeloma using mass spectrometry. Blood 2022; 139:946-95
2. Immunoglobulin Isotypes (GAM) for the EXENT Analyser Instructions for Use
3. Puig N, et al. Clinical Impact of next generation flow in bone marrow Vs QIP-Mass spectrometry in peripheral blood to assess minimal residual disease in newly diagnosed multiple myeloma patients receiving maintenance as part of the GEM2014MAIN Trial. Blood; Presented at ASH 2022; 140:866a
4. Puig N, et al. Analysis of treatment efficacy in the GEM-CESAR trial for high-risk smoldering multiple myeloma patients: Comparison between the standard and IMWG MRD criteria and QIP-MS including FLC (QIP-FLC-MS). J Clin Oncol 2020; 38:8512a
5. Berlanga O, et al. Two cases of multiple myeloma achieving complete remission but presenting residual M-protein by the EXENT® solution. Presented at AACC 2023; B371a
6. Puig N, et al. QIP-Mass Spectrometry in high risk smoldering multiple myeloma patients included in the GEM-CESAR Trial: Comparison with Conventional IMWG Response Assessment. Presented at AACC 2020; B-341a
7. Derman BD, et al. Comparison of monoclonal gammopathy assessed by mass spectrometry vs. serum protein immunofixation in peripheral blood in Multiple Myeloma. Presented at AACC 2020; B-351aa
8. Lajko M, et al. Using QIP-MS to distinguish a therapeutic mAb from an endogenous M-protein in patients being treated for multiple myeloma. Presented at AACC 2018; A-328a
9. Mai EK, et al. Implications and prognostic impact of mass spectrometry in patients with newly-diagnosed multiple myeloma. Blood; Presented at ASH 2022; 140:968a
10. Dispenzieri A, et al. N-glycosylation of monoclonal light chains on routine MASS-FIX testing is a risk factor for MGUS progression. Leukemia 2020
EXENT, EXENT-iP500, EXENT-iX500, EXENT-iQ, and Optilite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries.
*The EXENT System combines EXENT Analyser with the Immunoglobulin Isotypes (GAM) for the EXENT Analyser.
**EXENT Analyser (ARTG no. 454106); EXENT Immunoglobulin Isotypes (GAM) for EXENT Analyser (ARTG no. 460347)
***The EXENT Solution consists of the following CE marked products:
EXENT Analyser, IE800 (IVDR Class A, non-sterile).
Immunoglobulin isotypes (GAM) for the EXENT Analyser – MSR801.M (IVDR Class C).
EXENT Immunoglobulin Isotypes (GAM) Control Pack – MSQ801.M (IVDR Class C).