The Eeva Test is now commercially available in the United States following its recent US FDA clearance. This breakthrough technology is designed to help fertility clinics select the best embryos during in vitro fertilization (IVF) to aid in their effort to provide the best chance of a successful pregnancy.

The Eeva Test is a first-in-class, non-invasive predictive test that enhances the embryo selection process by taking images of the embryos during the incubation period. The Test uses proprietary time-lapse image analysis software that was developed to take advantage of a scientific discovery at the Stanford University School of Medicine which identified specific cell division timings that can be used to predict embryo developmental potential.

These automated, objective test results can now be used along with standard morphology grading to select the best embryos. This technology provides information to help clinicians move towards their objective of single embryo transfer.

The traditional morphology grading process used to choose embryos for IVF involves visually examining them under a microscope, grading them based on several visual characteristics observed by the clinician, and then, based on this grading, selecting them for transfer into the woman’s uterus.

When there are several embryos that look similar, embryologists can have a difficult decision to make in selecting which embryo or embryos to transfer. The Eeva Test improves this process, providing clinicians additional information to aid in their embryo selection.

“The development of the Eeva Test marks a major milestone in the IVF field,” stated Barry Behr, co-founder of Auxogyn, Inc., the company that developed the Eeva Test. “There is no other non-invasive test on the market that gives us information the Eeva Test provides about embryo development.  This additional information can help us not only select better embryos, but with the added confidence from using the test results, we can also transfer fewer embryos to help reduce the multiples rate with our patients.”

The Centers for Disease Control and Prevention reports that in the United States, one out of eight couples is impacted by infertility and 40 percent of them seek treatment, many through IVF. Only about one-third of IVF cycles result in live births, and in the United States, nearly one third of live births are multiples, due to the desire of couples to transfer multiple embryos to increase their likelihood of pregnancy in one cycle.

FDA clearance of the Eeva Test was based on a clinical validation study that demonstrated the test to be informative in identifying embryos with the highest development potential, when used with morphology. This study showed that when a panel of five embryologists adjunctively used the Eeva Test their ability to accurately predict embryo development increased by an average of 53 per cent over traditional, morphological grading alone.

“One of the most important factors in a successful IVF cycle is selecting the best embryo or embryos to transfer and the Eeva Test is a safe and effective non-invasive test that provides important information in helping make that selection,” stated Arthur L. Wisot, M.D. from Reproductive Partners and clinical professor, department of obstetrics and gynecology at the University of California, Los Angeles School of Medicine.

The Eeva Test has been commercially available in Europe for over two years, helping thousands of couples achieve a successful IVF outcome.