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The mAbXmise quantification kits are intended to monitor the concentration of therapeutic monoclonal antibodies (mAbs) in samples from patients treated with these mAbs. The kit is a quantitative assay. The test can be performed on plasma (EDTA, heparin or citrate collection tubes) and serum. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product.
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mAbXmise monoclonal antibodies quantification kits are In Vitro Diagnostic Medical Devices for laboratory professional use and CE-IVD labeled for Europe by BSI. Assay results are intended to be used by healthcare professionals. The kits are designed to perform absolute quantification by LC-MS (Liquid Chromatography – Mass spectrometry) of specific therapeutic monoclonal antibodies (mAbs) in a patient sample. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product. The products are non-refundable. The mAbXmise Kit described has not been cleared by any regulatory entity for diagnostic purposes outside of Europe. Proteomics mAbXmise Kits are not available for sale in all countries.
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Therapeutic Drug Monitoring solutions developed by Grenoble-based MedTech Promise Proteomics are being used in the NIPISAFE clinical study, a phase 2 clinical study sponsored by GERCOR and whose principal investigator is Dr Romain Cohen (Saint Antoine Hospital, Paris). The main objective of NIPISAFE is to identify a new immunotherapy regimen, more effective and less toxic, for selected colorectal cancer patients. As part of this study, several parameters are being monitored including the concentration of the two co -injected immunotherapies, Nivolumab and Ipilimumab. This quantification assay is carried out in the pharmacology laboratory at Henri Mondor hospital, headed by Dr Anne Hulin, using mAbXmise Oncology kits, developed by the company Promise Proteomics.
“We were fortunate to be able to collaborate very early on with health professionals, like Anne Hulin, who were interested in our technology. It’s a source of great pride to see our solutions at the heart of clinical studies such as NIPISAFE, which will undoubtedly lead to advances in the fight against cancer” explains Dorothée Lebert, Scientific Director of Promise Proteomics.
Promise Proteomics’ contribution to the NIPISAFE study also involves the evaluation of the immune response to the combined treatment Nivolumab and Ipilimumab. Among the parameters monitored, this involves measuring the concentration of anti-drug antibodies, likely to weaken or inhibit the expected therapeutic effect. This brand new technological approach to monitoring anti-drug antibodies by mass spectrometry was specifically developed by Promise Proteomics for this project, capitalizing on its experience in monitoring inflammatory diseases.
About Promise
The ambition of Promise Proteomics and its mAbXmise range is to adjust the dose for each patient, enabling a new advance in the personalized management of pathologies eligible for biotherapies. This MedTech, 100% owned by the Aguettant group, has unique know-how in the production of internal standards for protein assays and recognized expertise for mass spectrometry assay methods. Promise Proteomics now offers a mAbXmise range, comprised of 7 kits (CE-IVD status obtained or in the process of being obtained), allowing the dosage of 20 therapeutic antibodies used routinely in various pathologies.
About GERCOR
Created in 1997, GERCOR is a non-profit organization whose mission is to improve treatments for cancer patient (solid tumors) through innovative and multidisciplinary clinical research. GERCOR is a promoter of clinical trials (Ph I to III) and strives to conduct them in complete independence. It relies on a national network of 300 centers (university hospitals, cancer centers, general hospitals and private centers), as well as collaborations with other academic groups in France and is internationally coordinated by an operational team certified by the National Cancer Institute (INCA) and the National League Against Cancer.
