|Background: Subfertility poses an enormous burden on healthcare since 15% of couples suffer from subfertility.Chlamydia trachomatis (CT) is the most common cause of tubal pathology (TP) and subsequent infertility. In many countries subfertile women get a CT serological test (Chlamydia Anti-body test (CAT)) to decide who will get an invasive laparoscopy (CAT+) to assess TP (IVF candidates) or who try to get pregnant for another year (CAT-). However, of the 80% CTA- women, u to 20% have TP, and up to 45% of the women who are CT serology positive do not have TP. So there is a clear unmet clinical need for improving the triage for women. TubaScan Ltd in collaboration with Elucigene Ltd and ClinicaGeno Ltd will add host genetic markers in relation to CT susceptibility and severity of infection to the serological testing to better identify women with TP.
Funding: the translational research line for developing the host genetic biomarker assay id funded through a EuroTransBio (ETB) grant (total €3,3M) ending 31th October 2015, and is follow-up by a Eurostars grant (1.6M) which had his kick-off meeting 5th of October 2015.
Step 1: identification of candidate genes and identify single nucleotide polymorphisms (SNPs) which can be used as host genetic biomarkers for the susceptibility to and severity of disease. Amongst others GWAS analyses and SNP confirmations studies are used to select a set of 50 SNPs from the strongest candidate genes.
Step 2: in collaboration with ClinicaGeno we are building an algorithm to identify women at risk for developing tubal pathology after a CT infection or other sexually transmitted diseases, and to build an collaborate with ClinicaGeno to build an on-line analyses tool based on a prediction algorithm.
Step 3: in collaboration with Elucigene the in house format will be transferred to their ARMS technology platform, for future marketing on the TubaSCAN Assay currently in development.
Step 4: the last step will be CE-IVD certification based on the results obtained from prospective clinical studies incolaboration with amongst others Uppsala University and Hospital (Sweden), University Medical Center Groningen (UMCG, The Netherlands) and the Maastricht University Medical Center (MUMC, The Netherlands).