PITBUL | Point-of-Care implementation of TB testing with ultra-fast Local Heating PCR

Summary
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.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/768889
Start date: 01-12-2017
End date: 30-11-2020
Total budget - Public funding: 3 858 771,25 Euro - 3 858 771,00 Euro
Cordis data

Original description

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.

Status

CLOSED

Call topic

NMBP-13-2017

Update Date

27-10-2022
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Horizon 2020
H2020-EU.2. INDUSTRIAL LEADERSHIP
H2020-EU.2.1. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
H2020-EU.2.1.1. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)
H2020-EU.2.1.1.1. A new generation of components and systems: Engineering of advanced embedded and energy and resource efficient components and systems
H2020-NMBP-X-KET-2017
NMBP-13-2017 Cross-cutting KETs for diagnostics at the point-of-care
H2020-EU.2.1.2. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies
H2020-EU.2.1.2.0. INDUSTRIAL LEADERSHIP - Nanotechnologies - Cross-cutting call topics
H2020-NMBP-X-KET-2017
NMBP-13-2017 Cross-cutting KETs for diagnostics at the point-of-care