Reliable, accurate diagnostic tools to predict tubal damage to the ovaries in women with CT-associated subfertility are lacking. TUBATEST will deliver a diagnostic assay together with decision-supportive software validated for clinical applications and a service to expand and update its use.
Optimised SNP biomarker panel.
Our SNP panel was developed in a single cohort study. Since SNPs are very heterogeneous between populations, there is a need to assess and improve the performance in independent, well characterised cohorts. TUBATEST allows for the expansion and optimisation of the SNP panel. Furthermore, TUBATEST will show the added clinical value of the optimised SNP panel for subfertility patients. This results in an independently validated biomarker panel to be included in a diagnostic assay.
Algorithm to support clinicians
Clinical decision making based on the outcome of 50 different SNPs presents a challenge for gynaecologists. TUBATEST will develop an algorithm based on the optimised SNP panel and already available data. The algorithm will be incorporated in a software tool which will provide a positive or negative risk tubal-factor-subfertility score to the clinician through an easy, online interface.
Feasible diagnostic assay
TUBATEST will entail a feasibility study about implementing the optimised SNP panel into a commonly used diagnostic assay format, i.e. the ARMS format of Elucigene. Subsequently, we will perform the transfer of the optimised SNP panel to the ARMS format to create a diagnostic assay that will be marketed.
Service platform for business development
To reach the entire market, we will provide a service to low volume users, such as clinicians and CROs. This also enables TUBATEST to further investigate the SNP panel in future by gathering genetic data of different ethnic populations, which will serve to update and expand the diagnostic assay into new geographical markets.