Recent developments in molecular tools combined with updated epidemiological data provide novel challenges to the development of modern molecular diagnostics. The increasing threat of infections due to Mycobacterium tuberculosis, including multidrug-resistant (MDR) and extensively drug-resistant (XDR) infections, poses important questions that call for development of integrated tools for rapid diagnosis.

In the specific case of tuberculosis (TB), an integrated rapid diagnostic approach should be able to allow simultaneous species identification, drug susceptibility testing and molecular typing.

We propose to develop and validate a silicon-based platform for molecular biology testing consisting of a single disposable device (biochip) and associated specific instruments (reader). This technology is able to simultaneously serve as a platform for highly specific amplification and hybridisation of selected targets, and to provide a diagnostic report within a few hours. The main advance over existing technology (i.e. Real-Time PCR) is the possibility to perform the test at competitive costs, using an higher number of genetic probes, by integrating multiple, separate PCR chambers and a medium density array (50-200 probes), with faster and more stable amplification and hybridisation reactions through optimised and controlled thermal ramps and profile.

In addition to the technology development, the project will be specially focussed on the feasibility and cost-effectiveness of such a novel tool with high technological content for application in countries with high TB, MDR- and XDR-TB incidence. In parallel to the development and validation of the chip-based diagnostic platform for TB, a feasibility study on its applicability to other poverty related diseases such as malaria will be carried out. In summary, the present proposal aims at developing an affordable, high-tech platform for rapid molecular diagnosis applicable to TB and other infectious and poverty-related diseases.