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NeXT generation of biotherapy monitoring by mass spectrometry 

At Promise, our mission is to bring transforming solutions that will make personal, individualized therapy a reality for patients. For healthcare professionals wanting to treat their patients using a personalised approach, we have developed the mAbXmise range of products. Utilising mass spectrometry and a new approach: our kits make therapeutic drug monitoring (TDM) of large molecules easy.

A PERSONALISED DOSE FOR EACH PATIENT

Gathering analytical, pharmacological and clinical expertise with one objective: to completely transform the patient journey.

 

Now available in clinical practice, mAbXmise kits are designed to help healthcare professionals in their decision making when crafting effective treatment plans. Our kits can help provide unique-to-patient information in many therapeutic areas, allowing accurate dosage adjustment and a reduction in treatment costs.

 

An invaluable tool for hospital pharmacists using TDM, mAbXmise provides accurate insights which can then be applied to patient treatment plans. mAbXmise kits offer a more sustainable alternative to generic prescriptions: Often the results of TDM leads to a reduction in drug dosage, proving cost effectiveness and helping patient well-being[1].

 

mAbXmise determines the plasma concentration of monoclonal antibodies prescribed as single or combination therapies at selected time points. Its unique technology is based on mass spectrometry and allows multiplex measurement (several mAbs at once) with high analytical performances. The kit is designed to be easy to use and allows optimal reliability and accuracy using LC/MS technology[1]

 

Promise Proteomics is dedicated to bringing transforming solutions that will make personal, individualized therapy a reality for patients. Ultimately this will improve the patient experience, and patients’ prognoses.

“A few years ago, I would say that LC/MS is not suitable for mAbs because LC/MS is more suitable in measuring small molecules and it’s very complicated to measure proteins and mAbs. Today, the method is more reliable and can be successfully used with generic kits. With the kits, it’s easier to implement them in clinical practice. The instructions are very clear.”

Pharmacologist, The Netherlands

Our range of
diagnostic kits

mAbXmise is a unique commercial ready-to-use kit approach, based on mass spectrometry, including stable-labelled mAbs as Internal Standards, and CE-IVD. The solution is designed to monitor the concentration of therapeutic mAbs in samples from patients treated with these mAbs. The kit enables quantitative analysis to be performed on plasma and serum. The kit is an in vitro diagnostic medical device intended for professional laboratory use. The results of the analysis are intended for use by healthcare professionals.

There are numerous benefits to using mAbXmise kit technology:

  • Drug monitoring helps reduce the chance of toxicity: Overexposure can be anticipated by monitoring drug concentration in blood[2]

  • This multiplex LC-MS/MS method outperforms other methods for patient receiving combination therapies (or treated conjointly with 2 monoclonal antibodies), saving time and money[3]

  • Mass spectrometry produces an analytical robustness compared to immunoassays[4]

 

CONTACT US

OUR EASY TO USE KITS

Our mAbXmise kits are complete read-to-use solutions for facilitating the quantification of monoclonal antibodies using mass spectrometry in the laboratory.

SIL-mAbs are incorporated in our mAbXmise kits for ensuring quantification performances.

The solution provided enables to perform the pre-analytical steps before LC-MS analysis, and is compatible with most of the LC-MS configurations and brands.

To ensure a satisfaying experience, technical support is provided and our application team wil be at your side during the implementation phase.

INCLUDED IN EACH KIT :

-96 well plate coated with stable labelled mAbs (internal standards)

-6 Calibrators

-2 Quality Controls

-Suited buffers and solutions

-Specific consumables

-Protease

Our PRODUCTS

The range developed by Promise Proteomics includes 10 products

Our technology step-by-step

Key assets

From the patient’s blood sample to the monitoring of therapeutic antibodies,
mAbXmise diagnostic kits are:

EASY-TO-USE

sample preparation with mAbXmise labelled

internal standards added to blood sample

MULTIPLEX

quantitative analysis

using mass spectrometry,

measuring simultaneously

several therapeutic mAbs

ACCURATE

measurement of therapeutic mAbs

with 100% accuracy and

specificity according to

the peptide signature

« Current treatment regimens are still either single-dose or calculated on the basis of patient weight, whereas there is increasing evidence of inter-patient variability due to several factors such as age, gender, pathological state and others.

With mAbXmise, we hope we can facilitate the adoption of this practice in the hospital, to allow individualized medicine by personalizing the frequency of administration, compensate for inter-individual variability and reducing treatment costs.”[3]

Dorothée LEBERT, Chief Scientific Officer, Promise Proteomics

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.

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 and is directed by Dr Eric Rougemond.

 

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. Promise portfolio counts already 3 CE-IVD products and the team is engaged in CE-IVDR certification of new products.

 

Lean more about Promise Proteomics

 

10

articles cliniques publiés citant les kits mAbXmise

10

articles cliniques publiés citant les kits mAbXmise

> 20

études de recherche clinique utilisant nos kits en cours en Europe

> 20

études de recherche clinique utilisant nos kits en cours en Europe

4

Brevets

4

Brevets

10

kits multiplex disponibles

10

kits multiplex disponibles

38

mAbs disponibles dans nos solutions (kits et SIL-mAbs)

38

mAbs disponibles dans nos solutions (kits et SIL-mAbs)

6

aires thérapeutiques

6

aires thérapeutiques

Our references & awards

KEY REFERENCES

Discover our references in our Resouce 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