PITBUL

The overall goal of this project is to bring the unique, ultra-fast Local Heating PCR technology and its current lab-proven prototype instruments from TRL 4 up to TRL 6 into clinical demonstration in tuberculosis centers in Italy, Latvia, and Tanzania. This will imply a fully automated workflow on the instrument and all necessary reagents onboard of the integrated disposable cartridge, and a cloud based software for tracking epidemiological patterns. The application, ultra-fast point-of-care testing (POCT) for tuberculosis (TB) as well as emerging TB resistance markers, is an unmet healthcare need, not only in Europe, but globally. About one third of the human population is thought to carry the pathogen. One patient with active TB can typically infect 10-15 others. In the EU, the highest incidence rates are observed in Eastern Europe and the Baltic region. Furthermore, a very recent surge has been observed in some EU countries, e.g. in Germany, mainly due to higher mobility and migration. On top of this, multi-drug resistant (MDR) TB strains are becoming epidemic, causing exploding treatment costs. Active tuberculosis needs to be rapidly detected at hospitals, in- and out-patient clinics, specialized TB centers, jails, community centers, and shelter facilities. Such a test should be highly sensitive and capture all of the clinically relevant mutations that confer resistance in TB; if only one mutation escapes detection, the wrong treatment decision might be made, leaving the patient infected and capable of spreading resistant pathogens. Therefore, a panel of multiplexed markers will be adopted to LPCR in this project. It is ultimately the project’s ambition to develop a European-based contender in the emerging molecular POCT system space. The integrated TB/MDR TB LPCR system, a break-through-technology, aims specifically at impacting healthcare, TB knowledge and capacity building, and enabling future commercial success of the products.