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Reference standards for a specific, reliable and early detection of the marine toxins that causes ciguatera disease

Periodic Reporting for period 1 - CIGUALERT (Reference standards for a specific, reliable and early detection of the marine toxins that causes ciguatera disease)

Periodo di rendicontazione: 2015-07-01 al 2015-12-31

Microalgae are photosynthetic organisms that form the primary level of aquatic ecosystems. In some cases, periodic explosions of growth may occur, and these dense growths of microalgae are broadly named blooms. When the blooming microalgae have properties that are deemed harmful to natural resources, humans or other life, the blooms are called Harmful Algal Blooms (HABs). There has been in recent decades an increasing geographical distribution, frequency and intensity of HABs episodes, which may involve some species of microalgae that produce toxins (phycotoxins) that may be accumulated through the marine food chain. These toxins are accumulated in marine organisms that feed by filtering large volumes of water such as shellfish and other fishery products used for human consumption, causing serious public health risks and a socio-economic problem for the fish and shellfish industry.

The identification and quantification of ciguatoxins (CTXs) in seafood and fish is a vital issue to control proliferation and prevent consumers from ciguatera fish poisoning, which is a complex syndrome comprising a broad variety of gastrointestinal, neurological and cardiovascular symptoms, including fatal outcome. These marine toxins should be monitored in fishery products for health risk prevention, but currently there is no an analytical test available for their detection and quantification because there are not reference standards commercially available for CTXs, which is the objective of the present project CIGUALERT. Standards are materials containing a precisely known concentration of a substance for use in quantitative analysis. Accordingly, it provides a reference that can be used to determine unknown concentrations.

CIGUALERT project has focused on the commercial development and further commercialization of analytical standards able to substitute current and unspecific unique mouse bioassays method for the detection of marine ciguatoxins in fishery products for a specific, reliable and rapid chromatographic analytic method, allowing the quantification of ciguatoxins content and contributing to a more ethical society in issues related animal testing, and a more accurate protection of public health. The expected benefits of this project are not only economic, but also social and environmental. T

CIGUALERT had the following specific objectives:
- Develop a business and exploitation plan, including the assessment of the cost-effectiveness and exploitation potential of the envisaged solution which collects strategy company to sell standards
- Tackle the main bottlenecks and barriers for the full commercialization of the innovative technologies.
- Analyze market and business strategies in the sector.
The SME Instrument Phase 1 CIGUALERT has allowed to carry out a detailed feasibility report on ciguatoxin standards . As a result, a very promising business opportunity in the field of Public Health and Food Security monitoring has been identified. The work performed in the context of this project included:

1. Establishment and description of the business opportunity
2. Assessment of the market
3. Identification of potential customers
4. Establishment of the process required to produce the product
5. Improvement of the processes related to expected sales
6. Possibilities to develop a range of products
7. Detailed market study, with financial and economic forecasts for the initial years of market introduction.

We can outline as the main outcomes of this work:

1. Product assessment
2. Product sales forecast
3. Demand of product
4. Potential customers of the new products
5. Financial viability of the project, including its business plan.
Current feasibilty study has shown the potential of the product to be developed in the next years.

The Phase 1 results reached the following conclusions to be implemented in the near future:
1. Design a product family, including process strategies.
2. Scaling-up the production.
3. Focus on the enhanced performance verification to sell the product as internal standard.
4. Further funding required, SME phase2 and private investors will be evaluated

The benefits of CIGUALERT will be not only economic, but also social and environmental. The expected impacts of project comprises:
- Health Impact. Considerable reduction of the number of people affected annually by Ciguatera Fish Poisoning (CFP). This number could be increased up to 500.000 cases/ year.
- No use of any animal. Reduced animal testing substituting current MBA by an analytical method. A potencially high number mice killed per year could be avoided if MBA for CTX detection will be substituted by an analytical method.
- Comply with the legislation with a reliable method. Increase ciguatoxin’s controls in European imported fish to guarantee the total absence of CTX and increase the controls also in other non-European countries.
- Faster response time
- Increase international awareness about the importance of CTX control to prevent Citaguera disease
Microalgae Bloom