Webpages reserved for healthcare professionals based in EUROPE.

This website contains promotional content and information on medical devices, the use of which is reserved for healthcare professionals and laboratory professionals using IVD devices.

In application of the law of December 29,2011 relating to the strengthening of health security, I certify that I am a healthcare professional or a laboratory professional using IVD devices, I certify that I’m based in a European country and therefore I’m authorized to access this information.

For other countries, the webpages are under construction. Please contact us to get information contact@promise-proteomics.com

 

Accept Refuse

Fermer le menu

 

SUPPORTING THERAPEUTIC DRUG MONITORING OF MONOCLONAL ANTIBODIES BY MASS SPECTROMETRY 

Promise Proteomics has developed the mAbXmise® range of products for monitoring both therapeutic monoclonal antibodies (t-mAbs) concentrations and corresponding Anti-Drug Antibodies (ADAs) levels using Mass Spectrometry (MS). The proteotypic peptides, i.e. signature peptides, issued from trypsin digestion of the t-mAbs and their labelled forms (internal standards) are measured by LC-MS.

Promise focalizes its Expertise in tdm

Promise Proteomics is a French provider of quantification solutions for t-mAbs and ADAs and innovates by using the analytical performance of MS to support their quantitative monitoring.

* Analytical precision is evaluated in accordance with the requirements and recommendations of CLSI standards, in particular EP05, which relates to the evaluation of measurement procedure precision.

** Trueness and reliability of quantification are supported by the evaluation of mAbXmise kits metrological traceability in accordance with the requirements of ISO 17511, ensuring appropriate traceability of measurement results to recognized references.

 

The analytical performance mentioned above are reported in the corresponding Instructions for Use (IFU). The IFUs are available in the Customer Area. Please reach us for any question regarding the analytical performance.

Our Range of mabxmise kits

mAbXmise® is a range of products based on MS and incorporating Stable-Isotopically Labelled (SIL) t-mAbs as internal standards. mAbXmise kits are designed to perform Liquid Chromatography coupled with Mass Spectrometry (LC-MS) quantification of specific t-mAbs.

Refer to the Sections below to identify which kits are CE-marked (European Conformity) or with Research Use Only (RUO) status.

DISCOVER OUR MABXMISE SALES CATALOGCONSULT OUR SAFETY DATASHEETS

CE-marking kits (1)

6 kits are CE-IVD. 4 of them are classified as Class B under the IVDR.

Promise Proteomics is engaged with the notified body BSI Group The Netherlands B.V. (Notified Body number: 2797).

The test results are intended for use by healthcare professionals.

 

RUO kits (2)

8 kits have not yet been approved for CE-marking but these kits remain available for Research & Development purpose with RUO status.

The tests results are intended for use by research laboratory.

mabxmise kit content

mAbXmise® range is structured around two product families: one dedicated to the quantification of t-mAbs and the other to the quantification of Anti-Drug Antibodies (ADAs). Today, the portfolio includes TDM kits covering the quantification of 29 t-mAbs, as well as ADA kits covering the quantification of 4 anti-mAbs.

mAbXmise technology, step-by-step

The following video is for illustrative purposes only and provides an overview of the TDM kit preparation workflow.

It does not replace the corresponding IFU, available in the Customer Area.

 

Scientific & technical resources

Explore Promise Proteomics’s Scientific & Technical Resources!

Access a selection of materials related to the mAbXmise ecosystem and

quantitative proteomics: Resources – Promise Proteomics website

 

The Resources section brings together webinars, scientific posters presented at congresses, peer-reviewed publications citing mAbXmise kits, technical notes, videos and other scientific documentation. These materials provide additional information on therapeutic areas, targeted proteins, analytical approaches and the use of MS for quantitative protein and t-mAbs analysis. This dedicated space is designed to help healthcare and laboratory professionals access supporting scientific and technical information in one place.

CONTACT PROMISE PROTEOMICS TEAM

Regulatory Information

The mAbXmise quantification kits are in vitro diagnostic medical devices (IVDMD) intended for professional laboratory use and are CE-IVDR certified for Europe by BSI. The test results are intended for use by healthcare professionals. The kits are designed to perform absolute LC-MS quantification of a specific therapeutic monoclonal Antibody (t-mAb), an Antibody-Drug Conjugate (ADC) or a protein in a sample.  Before use, please carefully read the Instructions for Use supplied with the product. mAbXmise products are non-refundable. mAbXmise kits have not been approved by any regulatory body for diagnostic use outside Europe. mAbXmise kits are not available for sale in all countries.

Our company

Promise Proteomics was created in 2010 as a spin-off of CEA Grenoble (France). This medtech company is currently wholly owned by the Aguettant group.

 

Since 2013, Chief Scientific Officer of Promise, Dorothee Lebert, has led ambitious and collaborative R&D programs which have allowed to develop the technology, on which the diagnostic kits for personalized medical applications are based.

 

Capitalizing on its unique know-how in the production of internal standards for protein assays and its recognized expertise in mass spectrometry-based quantification methods, Promise Proteomics is placing its skills at the service of healthcare professionals through its mAbXmise kits.

Importantly, we are an integrated research & diagnostics company, meaning that we have the capabilities and experience to manage innovation, development or research & IVD products, manufacturing and market access.

Currently, the company holds 2 ISO certifications: ISO9001 and ISO13485, its QMS is CE-IVDR certified.

mAbXmise range counts already 3 CE-IVDD and 4 CE-IVDR products.

 

Lean more about Promise Proteomics

 

10

clinical articles published citing mAbXmise kits

10

clinical articles published citing mAbXmise kits

> 20

clinical reseach studies ongoing in Europe using our kits

> 20

clinical reseach studies ongoing in Europe using our kits

4

patents

4

patents

11

multiplex kits
available

11

multiplex kits
available

39

mAbs available in our solutions (kits and SIL-mAbs)

39

mAbs available in our solutions (kits and SIL-mAbs)

7

therapeutic areas

7

therapeutic areas

Our references & awards

KEY REFERENCES

Discover our references in our Resource Library

AWARDS

>Awardee of the Proof-of-concept program for ambitious R&D programs in public-private partnership, addressing a medical need in Oncology (2017)

> Semifinalist of AACC’s disruptive technology award session rewarding the next innovative testing solution that will transform patient care (2018)

 

The related patents numbers are :

US11543416, US11053303, US11630111, EP3165928, EP3165922, EP3457139 and EP4231017

[1] Puszkiel, A.; et al. Extending the dosing intervals of nivolumab: model-based simulations in unselected cancer patients. (2024). British Journal Of Cancer, 130(11), 1866‑1874. https://doi.org/10.1038/s41416-024-02659-x

[2] Broué, F. Advantages of monitoring biotherapies in oncology. La Lettre du Cancérologue, 90-91. 2022

[3] Marin, C.; et al. Cross-Validation of a Multiplex LC-MS/MS Method for Assaying mAbs Plasma Levels in Patients with Cancer: A GPCO-UNICANCER

Study. Pharmaceuticals 2021, 14, 796. https://doi.org/10.3390/ph14080796

[4] Millet A, Khoudour N, Guitton J, Lebert D, Goldwasser F, Blanchet B, Machon C. Analysis of Pembrolizumab in Human Plasma by LCMS/HRMS.  Method Validation and Comparison with Elisa. Biomedicines. 2021 May 30

Newsletter

Keep up with our latest news


    By submitting this form, I agree that the information entered may be used by PROMISE PROTEOMICS as Data Controller to respond to my request and declare that I have read the global policy on personal data protection available on the website.

     

    mAbXmise is a brand of 

     

     

    Promise Proteomics

    7, parvis Louis Néel • BHT 52 A • CS 20050

    38040 Grenoble Cedex 9 • FRANCE

    PHONE: +33 4 38 02 36 50

    promise-proteomics.com

     

    Last update: November, 2026 – Internal code: PROM-0023.V01-09.24

    Contact us

      By submitting this form, I agree that the information entered may be used by PROMISE PROTEOMICS as Data Controller to respond to my request and declare that I have read the global policy on personal data protection available on the website.

       

      Legal notices Privacy policy