FILODIAG

The problem: how to speed up PCR testing

With a disease like Ebola, there’s no time to lose. Typical diagnostic tests can take days to yield results, preventing health care workers from quickly determining whether a patient needs immediate treatment and isolation. If a patient has not been isolated while they await results of a blood test – not a realistic option in most cases – they have the potential to infect everyone in their social circle. On the other hand, keeping a healthy patient in a clinic risks exposing them to the disease. In the biggest Ebola outbreak that struck western Africa in 2014-2016, more than 11 000 people died. This number could have been greatly reduced had health workers had access to faster diagnostics.  

While fast and easy-to-use tests usually rely on immuno-diagnostic approaches, they tend not to be sensitive or specific enough to be dependable. A PCR-based test (polymerase chain reaction) is the gold standard. It’s a highly-sensitive diagnostic test that’s typically carried out in a laboratory, and involves a machine that heats up and cools down a purified sample multiple times following a particular sequence. The objective of this thermocycling is to allow the amplification of nucleic acids. While PCR tests are great for picking up tiny traces of the Ebola virus, they take time.

From multiple days to mere minutes

The FILODIAG project partners developed and tested a thermocycler that can heat and cool the target’s nucleic acids in a fraction of the time, returning results in about 15 minutes. SME partner GNA Biosolution’s proprietary pulse controlled amplification (PCA) technology uses locally heated microcyclers (laser-heated nanoparticles) to carry out the heating and cooling cycles of the nucleic acids to be analysed. If deployed widely, in a more portable and miniaturised format, this technology has the potential to uncover unknown transmission chains and hotspots. By facilitating early detection and isolation, it could minimise the number of people exposed and enable those affected to get the best treatment possible.

Small consortium, big impact

The consortium was able to cover the entire R&D value chain with just four partners. GNA Biosolutions, a small German SME, coordinated the project. They combined their proprietary PCA technology with sample preparation techniques developed by an academic partner in the Czech Republic (University of Brno), and carried out tests with real Ebola material in a bio-safety lab in Rome (INMI, “La Spallanzani”). The partners greatly benefited from the collaboration with Emergency, an international NGO on the ground in Sierra Leone, who helped to set up and carry out a field test.

Particularly in terms of benefits for SMEs, the connections made during the lifetime of the project helped GNA Biosolutions broaden their network, putting them in touch with prospective future partners in industry and academia. The company grew in size from about 12 people at the beginning of the project to 24 staff at the end, and they learned a great deal about coordinating an international project, encouraging the SME to embark on further future such projects.  

What’s next?

Thanks to the FILODIAG project, GNA Biosolutions has developed a commercial product for research use for diseases that require rapid diagnostics. A portable, shoe box-sized demonstrator with PCA for detecting Ebola is currently under development.

The FILODIAG project is part of the Ebola+ programme.