CAMBRIDGE, UK (2019-08-01) – ProteinLogic, the biomarker discovery and exploitation company, today announces the completion of its multi-site study on the use of its novel diagnostic technology, ImmiPrint®, for the ruling-out of Active Tuberculosis (TB) disease from a blood sample.
Previously, the company had shown that its ImmiPrint technology could achieve the requisite clinical accuracy in a significant internal study of approximately 1000 clinical samples on laboratory-grade immunoassay platforms.
Under an EU Horizon 2020 grant (ADVANTAGE 666308), the company built on this work and commissioned clinical studies for the collection of further blood samples from subjects suspected of Active TB disease. Prospective samples were collected from TB clinics in Brazil, South Africa, Spain and the UK. The tested combined cohort from all sites comprised 1343 genetically diverse clinical samples.
ProteinLogic’s test exceeded the WHO-mandated clinical performance of 90% and 70% sensitivity and specificity respectively. In particular, sensitivity was 91%, specificity was 75%, and Negative Predictive Value (NPV), a key measure for a rule-out test, was 94%. Such results have not been reported to date from a blood test from cohorts of mixed backgrounds, as immunoassay approaches have traditionally been optimized on local populations and do not apply well to different genetic backgrounds. Importantly, these results were obtained from analysis of the samples on a new immunoassay measurement device that could potentially be used at the Point-Of-Care, proving that the ImmiPrint technology is transferrable across platforms.
Dr Nicolas Huber, CEO of ProteinLogic, commented: “The results from our latest, multi-site study prove conclusively that ProteinLogic has achieved a significant milestone, not only as complete clinical validation of its ImmiPrint technology in TB, a very difficult to diagnose disease, but also in the development of a diagnostic test with the ability to support the fight against this deadly disease. Having built evidence of the applicability of our novel approach across measurement platforms, we are confident we are entering the market with a diagnostic solution that is readily adoptable in settings where it is needed most, and are looking forward to expanding our technology to other indications”.
ProteinLogic is preparing publications of these results in peer-reviewed journals.
The company would like to thank the EU for the support of its work through the Horizon 2020 grant mechanism. The company would also like to thank its clinical collaborators across the globe for their support in this study.