Implementation
Overview - A project built to be implanted
From the very start, we have conceived the DAISY project to answer a need and to be fully compatible with real-world implementation. This led to strong questioning about what we should favor between participating in the iGEM competition or patenting our idea both not being easily possible. Fortunately, or not, we did not have enough time to demonstrate the feasibility of the project over the four experimentation months. This means we could participate in the competition by exposing all our results while still having to reinforce our set up which could eventually lead to a patent.
Anyway, we have gone far in the business development of DAISY (see Entrepreneurship).
The goal of our company is to develop a new method to detect predispositions to allergies. This system, based on synthetic biology, will be non invasive for the patient and will eventually test hundreds or more of allergens simultaneously. It will provide solid data for allergists to establish their diagnosis. To achieve this goal, we will follow the 5 missions listed below in order of priority.
1 - Design a bank of bacterial strains
The first step towards the production of our detection method is to design the bacterial strains that will enable allergen detection (see Design). In particular, we have to create a library of E. coli strains, each displaying a different allergen.2 - Implant our system into a high throughput platform
To perform a screening of hundreds of these allergens at an industrial scale, we must set up our system in a microfluidics platform. We will use the microdroplets technology patented by INRAE (see Design) and coupled to an AI (Artifical Intelligence)-trained FACS platform, which will automatize the sorting of bacteria and enable accurate analysis of the patient’s blood serum.3 - Optimize the efficiency of the method
We must adapt the parameters of our system at all levels. Our modeling has shown that we must control many parameters (see Modeling) to eliminate a maximum of false positives and negatives, and so improve the accuracy of the method. As for the platform, we must adjust its parameters to ensure the swiftest detection of allergens and to guarantee that our analysis meets the market needs.4 - Integrate the system among the diagnosis tools of allergists
After having received approvals from multiple stakeholders (see Integrated Human Practices) that confirmed the necessity and the relevance of our method in the diagnosis of allergies, we are ready to integrate it among the existing methods. We must however conduct market research to evaluate the needs of the stakeholders, and competitive intelligence to be sure that the high throughput screening we propose will be a true added value in the diagnosis of allergies.5 - Diversify our activity through commercialization of desensitization medicine
Because the diagnosis only allows to detect allergies, we want to take it futher and be able to propose a solution to allergies. Thanks to the production of recombinant allergens by our bacterial strains, we will propose an efficient desensitization medicine using the exact same allergen than the one recognized by the patient's IgE. This desensitization treatment will be personalized for each patient.
According to the goals that we set in our Aims and Missions, we imagined the future of DAISY as a firm. Our objectives are to establish the following operating model in ten years. We took inspiration of the common operating model of medical laboratories thanks to our meeting with Annabelle Gordon-Le Goff, doctor and biologist in a medical analysis laboratory.
Here is presented a typical situation of diagnosis using the DAISY method:
- • A patient consults an allergist, who recommends performing a DAISY test for their allergies.
- • The patient goes to a medical laboratory and their blood is sampled.
- • The blood sample is sent to our DAISY laboratory to be analyzed according to our method.
- • The test results are then sent back to the allergist.
- • The allergist, trained to analyze the results of DAISY tests, will analyze the results according to their experience and knowledge, as well as the patient's medical history.
- • The allergist informs the patient and they can decide together which procedure to follow (eviction of the allergens, treatments, desensitization…).
In this model, the end user is the patient.
Typically, the patient is suffering from allergic symptoms and does not know what is causing them. He/She may or not have performed an inconclusive previous detection test (ELISA or Prick test). His/Her allergist will therefore advise using the DAISY method to get a full picture of the patient's predisposition to allergies. The patient will go to a medical laboratory and his/her blood sample will be then transferred to a DAISY laboratory specialized in performing the DAISY method.
The results will then be sent to the allergist who will inform the patient about the results and the action to be taken (prevention, global treatment or personalized desensitization using the DAISY method since the strains expressing the incriminated allergens have already been isolated during the detection step).
With this implementation model, safety will be at its highest level since only professionals will manipulate microorganisms in a laboratory environment. Maintenance of the E. coli bank, culture, high-throughput analysis, and cell inactivation (autoclaving for instance) will be all performed in the same environment (see Entrepreneurship).
In the next Supporting Entrepreneurship section, we describe in detail the analysis of our capabilities, our business model, the laboratory organization, its sustainability, and evolution.
Figure 3: Overview of the Supporting Entrepreneurship section
