With the support of the Horizon 2020 funding, to date, ProteinLogic has optimized its TB biomarker immunoassay panel, containing a much smaller number of analytes, meaning potentially much lower costs per test. The TB signature has further been enhanced by new diagnostic models, generated through the use of advanced Machine Learning techniques in collaboration with world-class biostatisticians. Most importantly, this unique signature has been clinically validated with a large, ethnically diverse, well-characterised, statistically significant patient sample cohort collected prospectively from TB clinics in London, UK.
The achieved performance of the test is a break-through. The level of accuracy exceeds that currently required by the W.H.O for a rule-out test for Active TB (sensitivity > 90%, specificity >70%). Crucially, the test has been shown to perform equally well for difficult-to-diagnose Extrapulmonary TB cases.
Throughout the project, ProteinLogic has been working directly with a potential Point-of-Care device to port its highly accurate diagnostic test onto, with significant equivalence achieved between the reference platform and the POC device for our signature, in terms of detection sensitivity, paving the way to the final product.
To further validate this platform, ProteinLogic has commenced the collection of samples from South Africa, Brazil, and European countries, adhering to strict ethical guidelines, and ensuring full ethical approval for all work. By the end of this project, it is expected that we will have prospectively collected and analysed over 2000 clinical samples from high burden countries and European TB clinics. Clinical studies of such magnitude are very costly, and one of the main barriers for the development of new in-vitro diagnostics, and it would not have been possible for ProteinLogic to commission these without the help of the Horizon 2020 funding we have received.
Finally, we have been developing a full regulatory plan, to include major countries of interest to access once the project has completed. The regulatory landscape globally for diagnostics is changing rapidly, and ProteinLogic has been keeping abreast with developments to ensure successful market access.
