On the market there is a large number of genetic tests available, each directed to investigate whether a subject is affected by (or is a carrier of) a specific disease, like cystic fibrosis, thrombophilia mutations (e.g. Roche LightCycler based on colorimetry for thrombophilia), Y chromosome microdeletion, etc. These tests are provided to couples by laboratories and genetic clinics, but unfortunately rarely a laboratory can provide all the required tests, thus gynecologists need to work with many different laboratories. Their cost can vary depending on the laboratory (a single test for a gene mutation can cost up to 500€), reaching an average cost for couple of 2,500€ for two complete genetic tests (diagnostic and preventive purposes).
Compared to actual competitors, One4Two is the first kit that allows laboratories to offer a complete diagnostic service to infertile couples with a reduction in time and costs.
The main features that underline its competitive advantage over the traditional methods currently used are high performance (simultaneous analysis of more than 30 genes), greater reliability of results (> 99.9%) with the reduction of the incidence of false positives (<0.1%) and the highest sensitivity with the reduction of the incidence of false negatives <1%.
Overall One4Two is poised to reduce the time for diagnosis for a couple down to few days, which is revolutionary in this sector. Moreover all the results are gathered in a single report with a simple and clear data presentation, which will help gynaecologists in the interpretation reducing the human error caused by the adoption of many different tests, one for each pathology.
One opportunity highlighted by some stakeholders is related to National reimbursement: currently to have a complete clinical frame a specialist needs a lot of different diagnostic exams, which can be reimbursed by National System (for example in Italy) but are only available on certain labs. Thus a couple needs to travel across the country to go to different labs, and each lab will then send the reports to the specialist. This situation leads to unbelievable expenses for the whole value chain (the couple, the labs and the National System). There is a clear space to apply for National Reimbursement for One4Two, due to this improvement for results/money ratio, especially for National Health Systems.
