Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - AllerScreening (Point-of-care device based on KETs for diagnosis of food allergies)

Teaser

Food allergy is a common condition worldwide which prevalence is rising dramatically in both developed and developing countries. It is estimated that globally over 6% of the population, around 200 to 250 million people, suffer from some food allergies, affecting more than 17...

Summary

Food allergy is a common condition worldwide which prevalence is rising dramatically in both developed and developing countries. It is estimated that globally over 6% of the population, around 200 to 250 million people, suffer from some food allergies, affecting more than 17 million people only in Europe. Three million of European allergic patients are younger than 25 years old and the sharpest rise in food allergies is amongst children and young people . The most dramatic increase is seen in children and young people, especially in the number of life-threatening allergic reactions in children. For this, it is so important to improve the diagnosis of these diseases to implement specific treatments, as soon as possible. In this scenario, it is imperative to develop effective procedures for the early detection of main food allergies.

AllerScreening project focuses on translate an optical diagnostic technology already proven (AllerScreening), to the clinical routine, addressing a priority healthcare unmet need from the laboratory to the clinic. This new and innovative cost-effective sensing system for the in vitro component diagnosis of food allergies will allow clinicians to early detect main food allergies (at least the 90% of European food allergies) through a simple test using a drop of sera, reducing the cost and technical requirements of the current clinical practice.

The success of this project would not only contribute to early detection of food allergies in primary care, but also it might pave the way to further studies of immunological food intolerances due to its potential to a close monitoring of the evolution of the disease in patients providing useful insights to define personalized treatments.

The implementation of AllerScreening project has been intended to prove the feasibility of translating a proven PoC diagnostic technology (TRL4) into the food allergy market based on a patented disruptive technology. I

Work performed

AllerScreening focuses on translating an optical diagnostic technology already proven (PoC), to the clinical routine, addressing a priority healthcare unmet need from the laboratory to the clinic. To achieve this final goal, steps were taken in this first reporting period:

The definition of the target specifications for the produc and the adaptation of the PoC readers to target specifications have been the key activities for this first period. There have been significant advances regarding target specifications, and adtpatation to PoC reader. The PoC reader has been already validated for 60 wells in a very competitive time (less than 3 hours), where the measurements resuts were consistent among different assays. In summary, the Alerscreeening consortium has been able to achieve the following so far:
- At least 20 specific allergens to be detected by the PoC device have been selected.
- The requirements of multiplexed Biokit and reading platform were defined.
- The biochip has been described as an optomicrofluidic modular design.
- The main architecture of the IT system has been defined, and the groundwork has already been implemented (server, hardware, database).
- A multiplexed BioKit has been designed, therefore it allowed incubating the 20 proposed allergens being compatible with the liquid dispensation robot and with the optical readout system.
- Biofunctionalization of the BioKit surface with allergens has been accomplished at laboratory scale, The whole process of NPs-biofunctionalization with anti-human-IgE antibodies has been developed, standardized and checked, confirming its suitability for the project.
-A mono-tip methodology for automated surface-biofunctionalization with allergens has been stablished by using a robot for automated liquid dispensation (Feedom EVO system) and kits with plastic minibeakers (63 well kits).

Final results

AllerScreening project has been defined in order to address the unmet clinical need of diagnosing food allergies by CRD in vitro diagnosis, in shorter period of time, with lower associated costs and with results that can be interpreted by primary care givers, thus resulting in the possibility of transforming in vitro CRD as a first-line method of diagnosis in the food allergy market. This can be achieved by translating an optical diagnostic technology, already successfully tested in other applications, to the clinical practice.
Considering the above, the main expected impacts of AllerScreening project are the following:
1. Products
Resulting from the project implementation, AllerScreening members expect to deliver the following products with a direct impact in food allergy handling:
• An innovative Point-of-care, CRD in-vitro system, based on a biosensing optical system that analyzes the optical response of BIWELLs (Bio-Photonic Sensing Wells).
• Disposable BioKits: The chips can be used for the detection of the analytes, in this case, specific immunoglobulins. The possibility of variating the allergens disposed over the surface of the BioKits will shoot up the coverage of food allergy variants. As the prevalence of the different types of food allergy is highly dependent on the geographical area of the patients, a strategy based on disposable and customizable BioKits enhances the implementation of the system all over Europe and even the whole world, trying not to sideline any region because of economical or developmental reasons.


2. Clinical impact
The possibility of an improvement on the main features related to in vitro CRD methods may have the potential to become a game-changer in the field of early diagnosis of food allergies: molecular components of allergenic sources, along with more accurate results due to an enhanced defined IgE profile, lower costs, avoidance of high-skilled personnel to perform the assays and compatibility with SPTs, pave the way to introduce this technology as a first-level method in the diagnosis procedure and open the possibility of its wider adoption by private healthcare providers which is of the outmost importance in markets different to the European one, such as US.

3. Advance in integrated MNBS based diagnostic health platforms and contribution to the European industry

The multiplexed setting will lead to the design of a new BioKit–including microfluidic cartridge and additional adjustments in the optical reader. In addition, an optimization of all the protocols for immobilization of allergens and detection of immunoglobulins will be performed.
All these innovations will boost the current state of the device and it is expected that they will contribute to give competitive advantage to the partners promoting the project. In vitro allergy diagnosis market is strongly dominated by only two competitors. Once Allerscreening breakthrough takes place, European industrial network in general, and European allergy in vitro diagnosis market in particular will be improved by the competition resulting from this innovation.

Website & more info

More info: http://www.aller-screening.upm.es/index.php/en/home.