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Page 1 of 3 Development of a diagnostic validated analysis pipeline (FDA Class III) for leukaemia diagnostics (AML) Project call: Project #: Website: Project Abstract In the current market, the use of microarrays is focussed on the application for research purposes. Skyline Diagnostics has developed an acute myeloid leukaemia (AML) gene signature for diagnostics use. This is an important step to applying this technology for diagnostic use on patients. Because of the potential impact on patients different rules apply when using microarrays for diagnostics use. The ICT infrastructure and dedicated software poses difficulties for companies performing microarray analysis in a clinical setting. Lack of standardisation forces companies to invest substantially in such an environment. In a world that demands high throughput services in a limited amount of time there is a requirement for an infrastructure that can be applied on world-wide scale. This CTMM application provides the opportunity to develop an “ICT pipeline” that is compliant with these demands. Since many components of this ICT pipeline are generic, they can be applied for many different diagnostics products and indications. Although microarray based diagnostic products are the front end of medical technology and therefore leave a lot of opportunities and unknowns, it is evident that genetic based high throughput tests are the future and will provide clinicians with a truly personalised approach to individual cases. These tests will certainly require more and more storage and computing power in the future, therefore, a structured FDA approved ICT pipeline is essential and would offer a solution for many companies that are active in this field. |