Periodic Reporting for period 1 - Nexdiag (Revolutionising allergies diagnostics with the next generation of ultra-sensitive highly multiplexed diagnostic tests based on micro-pearls)
Okres sprawozdawczy: 2023-05-01 do 2024-07-31
Allergies are becoming a public health issue (in 2050, 50% of population will have allergies). One of the challenges that allergists are facing is to accurately and rapidly diagnose allergens that affect patients. Nonetheless, one symptom can have different causes and around 80% of people suffering from allergies have cross-allergies. Therefore, identifying all allergens is a long and tedious process. The main practice today, having a dedicated test for each allergen, complexifies the diagnosis. This also represents a higher cost, as patient are likely to do several tests before being properly diagnosed. There is thus an urgent need for better allergy diagnostic that simplifies the process and reduces time and costs.
To solve this issue, Nexdot has developped NexDiag :
NexDiag diagnostic kit comprises a solution of micro-pearls (µpearls) bio-functionalised with up to 1000 different allergens per test, and a solution of the variable domain of an antibody targeting the constant domain of IgE (the probe) co-expressed in tandem with a high fluorescence intensity GFP (Green Fluorescent Protein, the reporter). Both fluorescent particles, µpearls and GFP, can be linked together only in presence of the antigen specific IgE present in the patient serum and responsible for the allergic response. If the fluorescence of both µpearl and GFP are detected together, the system “anti- antibody-GFP/IgE/allergen/µpearl” is chemically bonded, that means the patient is seropositive for the corresponding allergen. Our solution offers unprecedented multiplexing capability enabled by the single-µpearl analysis benefiting of the unique relation between each colour code for a specific type of couple allergen-µpearls for assessing allergen-specific IgE.
Nexdiag outperforms by far the current state of the art. When the test development is successfully completed, Nexdiag will become the clear reference in the market of in vitro allergies diagnosis.
The main characteristics of Nexdiag in relation to the existing pains and expected gains are:
- It is highly multiplexed: it will allow to assay IgE on +1000 allergens with a single test using only one blood sample.
- It is extremely sensitive (Sensitivity 1nM, 3 log of dynamic scale), allowing to detect and quantitative measure each individual allergen in the blood sample. Having quantitative values for each allergen will make that the test results are more useful for the specialist to define the best treatment for the patient.
- It is 10-20x times cheaper than any other of the existing alternatives. We expect this test to be sold at 50€ thanks to low production cost. This implies an average cost of 5 cents per allergen tested. Current multiplexed tests in the market cost around 250-300 € per test, which implies a cost per allergen tested of approximately 1€. It is much cheaper than skin tests or other allergen-specific tests.
- It is very fast: Our test will be performed in an automated way at medical diagnostic laboratories and not by allergists,
which will represent a significant gain of time for allergists. Nexdiag tests can be performed in less than 20 minutes (vs 2-4 hours of our multiplexed competitors)
- It is non-invasive and simple so it can be performed at primary care or other similar clinical settings.
This innovation will revolutionize the way allergies are treated by reducing drastically the time to diagnostic, reducing the number of visits and relieving the already overburden allergist.
This projet is lead by Nexdot that will be in charge of finalizing the test in collaboration with Institut Pasteur and then exploit and commercialize this test to Medical Laboratories.
To solve this issue, Nexdot has developped NexDiag :
NexDiag diagnostic kit comprises a solution of micro-pearls (µpearls) bio-functionalised with up to 1000 different allergens per test, and a solution of the variable domain of an antibody targeting the constant domain of IgE (the probe) co-expressed in tandem with a high fluorescence intensity GFP (Green Fluorescent Protein, the reporter). Both fluorescent particles, µpearls and GFP, can be linked together only in presence of the antigen specific IgE present in the patient serum and responsible for the allergic response. If the fluorescence of both µpearl and GFP are detected together, the system “anti- antibody-GFP/IgE/allergen/µpearl” is chemically bonded, that means the patient is seropositive for the corresponding allergen. Our solution offers unprecedented multiplexing capability enabled by the single-µpearl analysis benefiting of the unique relation between each colour code for a specific type of couple allergen-µpearls for assessing allergen-specific IgE.
Nexdiag outperforms by far the current state of the art. When the test development is successfully completed, Nexdiag will become the clear reference in the market of in vitro allergies diagnosis.
The main characteristics of Nexdiag in relation to the existing pains and expected gains are:
- It is highly multiplexed: it will allow to assay IgE on +1000 allergens with a single test using only one blood sample.
- It is extremely sensitive (Sensitivity 1nM, 3 log of dynamic scale), allowing to detect and quantitative measure each individual allergen in the blood sample. Having quantitative values for each allergen will make that the test results are more useful for the specialist to define the best treatment for the patient.
- It is 10-20x times cheaper than any other of the existing alternatives. We expect this test to be sold at 50€ thanks to low production cost. This implies an average cost of 5 cents per allergen tested. Current multiplexed tests in the market cost around 250-300 € per test, which implies a cost per allergen tested of approximately 1€. It is much cheaper than skin tests or other allergen-specific tests.
- It is very fast: Our test will be performed in an automated way at medical diagnostic laboratories and not by allergists,
which will represent a significant gain of time for allergists. Nexdiag tests can be performed in less than 20 minutes (vs 2-4 hours of our multiplexed competitors)
- It is non-invasive and simple so it can be performed at primary care or other similar clinical settings.
This innovation will revolutionize the way allergies are treated by reducing drastically the time to diagnostic, reducing the number of visits and relieving the already overburden allergist.
This projet is lead by Nexdot that will be in charge of finalizing the test in collaboration with Institut Pasteur and then exploit and commercialize this test to Medical Laboratories.
Strong progress has been made on technical part during this first part of the project. We were able to push the limit on fabricating our nanoobjects. We also improved the protection of these materials to produce our Micropearls. We ensured that each of these Micropearls could be easily modified with biological materials or allergens. We are in progress of making a larger scale test on patient serums
Our technology has been found to be applicable to other areas in the IVD markets notably, developing IVD tests in detection of pathogens or other maladies