In-Vitro Fertilization (IVF) is a technology that introduces the female egg and male sperm together in a specialized culture medium where the chances of successful fertilization are greatly enhanced. The embryos are observed and grown for reintroduction to the recipient’s uterus at a multicell embryo stage or later at the blastocyst embryo stage.

In-Vitro Fertilization is a global growing market, but success rates are inadequate. Declining fertility rates and delaying pregnancy have resulted in ~11% of US women experiencing fertility issues. In that context, the total IVF market size in the US is US$ 4.4 billion and US$ 15 billion globally, growing ~10% per year. Undergoing an IVF often is an emotional process often accompanied by repeat disappointment and high cost. Today, less than a third of IVF cycles lead to successful birth, and those that do have a high ratio of multiple births per successful pregnancy.

The market is commercially attractive for a diagnostic tool that can enhance success rates of the procedure by preselecting only viable embryos for implantation.

PreImplantation Factor (PIF) is the earliest and most reliable biomarker of pregnancy. It can be determined earlier than Human Chorionic Gonadotropin (HCG), the standard marker today.

Not all embryos cultured in an IVF procedure produce PIF necessary for implantation into the uterus. A PIF based test may help reduce required IVF courses and increase take-home baby rates.

Our development objective is to provide the capability to, before implantation, identify which embryos are able to implant, eliminate/ reduce need for multiple embryo transplant which is current practice, reduce concomitant risk of multiple births, and allow single embryo transplant with confidence.