Kit (blood test) for in vitro diagnosis of risk of infertility, implantation failure at IVF and adverse pregnancy outcome for women

Challenge

There is a growing rate of infertility all over the globe. Reasons are mainly higher maternal age and yet undiscovered gynecological disorders. In fact no pathogenic biological mechanism has been detected to identify so-called “idiopathic sterility”, and obviously it remains an exclusion diagnosis for which diagnostic tests are not available. Although in vitro fertilization (IVF) is a widely spread treatment and the success rates of assisted reproductive technologies have markedly improved during the last decades, many of infertile patients experience unexplained implantation failures after IVF cycles, despite repeated transfers of morphologically normal embryos.

Technology

PLAC1 is a protein with a fundamental role in trophoblast differentiation and in placenta development across many different species. PLAC1 shows placenta-specific expression localized on the surface of the syncytiotrophoblast and therefore it is accessible for antibodies. Surprisingly, PLAC1 has also immunogenic properties. Importantly, we have shown that anti-PLAC1 antibodies can be rapidly and effectively detected (by ELISA). Antibody levels resulted significantly higher in about 25% of idiopatic infertile patients with repeated unexplained implantation failure when compared to control fertile women. They could represent a biomarker associated with infertility and with high probability of repeated implantation failure at IVF cycles

Commercial Opportunity

The global infertility market is poised to grow over the next years due to increasing infertility, improving healthcare infrastructure and more awareness. There are 90 million couples in the world who experience fertility problems, 25 million people in Europe alone, which is the continent where assisted fertilization is used most: it has gone from 100,000 cycles in 1995 to 700,000 in 2014. And the rate of fertility has been declining around the world in recent years. According to the latest report, in Italy during 2017, the number of IVF cycles started per million women of childbearing age between 15 and 45 years was about 7106. Given these assumptions, a quick and easy test predicting the possibilities of embryo implantation after IVF cycles could have wide commercial application. 

Development Status

We have developed the basic method and kit (ELISA assay) for in vitro detection of anti-PLAC1 antibodies. There is need to perform a larger study in order to obtain regulatory agencies approval and to extend the possible clinical applications of the test.

Patent Situation

Granted Italian Patent and European granted patent ( validated in France, Germany, Spain, United Kingdom, Monaco).

Further Reading

Matteo M, et al. Preliminary evidence for high anti-PLAC1 antibody levels in infertile patients with repeated unexplained implantation failure. Placenta 4: 335-339, (2013).