PRONOSTICS CLINICAL TRIALS
Unlike Pronostics' UltraScreen™ products, which can be validated by comparing the multiplexed products results with the conventional “one-analyte-at-a-time” diagnostics currently in use, Pronostics’ FingerPrint profiling assays represent an entirely new class of clinical diagnostic products for which there are no comparative assays. Specifically in the case of CADprint™, our first FingerPrint profiling product, there are currently no blood tests at all, which can diagnose coronary heart disease with acceptable sensitivity and specificity, and therefore provide comparative data. Consequently, securing regulatory approval and bringing our CADprint™ test to the marketplace requires a more extensive and rigorous clinical development program than for our UltraScreen™ products.
Pronostics has designed, and embarked upon, a comprehensive clinical development plan for CADprint™ which began in 2001 and which will be complete in Q3 2007. The CADprint™ clinical trial process will be mirrored for our follow on FingerPrint profiling products.
Pronostics’ Clinical Trials’ Objectives
The objectives of the clinical trials for CADprint™ are:
(a) To rapidly provide confidence that the assay performance characteristics identified in our pilot clinical studies can be reproduced in a larger population.
(b) To provide a databank of samples, collected in identical fashion to those which will be used to provide a clinical diagnosis, which is sufficiently large to allow a model to be constructed and which provides an unambiguous diagnosis for at least 90% of queries.
(c) To validate the process of obtaining a test result for unknown samples.
(d) To satisfy the various regulatory authorities and controls which currently exist or which may be subsequently imposed governing the provision of clinical diagnostic products and services based on UltraPlex™ FingerPrint technology; in particular the US Food and Drug Administration (FDA) who categorise our ground-breaking FingerPrint profiling products under the classification ‘In Vitro Diagnostic Multivariate Index Assays’ or IVDMIA’s, for short.
Pronostics’ Clinical Trial Design
To meet the above aims, two large-scale clinical trials have been undertaken. The first of these (termed MaGiCAD) was initiated in 2001 and patient recruitment was completed during 2006. The second, multi-centre, study (termed PUMA) began in Q3 2006 and will take approximately 15 months to complete.
More details of both trials can be found on their respective web pages.
