During Phase 1 of the BioGuidePCa project a team at the mosaiques diagnostics GmbH has investigated the clinical potential of diagnostic biomarker tests, namely the PCa Status Test and the mCRPC Progression test, for the application in the clinical needs that were summarised above. The PCa Status Test should be developed as a non-invasive seminal fluid based biomarker assay, that is able to differentiate between clinical significant from clinical insignificant disease, hence should guide radical prostatectomy and therefore reduce the associated overtreatment in at least 45% of the patients. The mCRPC Progression Test should be developed for the use in therapy for castra-tion resistant prostate cancer. Here it should detect early disease progression and predict therapy outcome. The market potential of both diagnostics was investigated in a feasibility study, including a business plan, a market analysis and a marketing concept. Based on the analyses, it was shown that both tests can upgrade prostate cancer management since no alternative diagnostics are currently available in the market. Based on this fact, the market potential of both tests is predicted to be high, with a total of 60,000 potential customers per year in Germany.
In the context of the feasibility analysis we also performed a preliminary study, investigating the producibility of the mCRPC Progression Test as well as the PCa Status Test. For the evaluation of the concept of the mCRPC Pro-gression Test, a total of 10 mCRPC patients and 16 non-mCRPC diseased controls were obtained from the Urology Department of the Hannover Medical School. Primary classification of the samples with a previously reported General Cancer biomarker classifier resulted in poor differentiation between cases and controls (AUC = 0.744). Hence the available samples were divided in a training- and test-set in order to perform further statistical analysis targeting the development of a new more specific biomarker classifier. Classification with the newly established specific mCRPC biomarker pattern resulted in an AUC of 1.0. We therefore suggest that the biomarker should be further developed in a subsequent study, best funded in the framework of Phase 2. For the preliminary study of the PCa Status Test, seminal fluid samples were analysed. A total of three biomarker classifiers were developed to allow accurate classification of the tumour according to its Gleason Score and TNM Stage. For all classifiers AUC values > 0.84 were obtained, verifying the functionality of the test according to the defined clinical need. Since the results of the preliminary study are excellent, both diagnostics test should be developed to marketability in the framework of the PHC 12-2105-2 call of the Horizon 2020 program.
