Merck Serono, a division of Merck, Darmstadt, Germany, and Auxogyn, Inc., a company focused on revolutionizing the field of reproductive health, today announced that they have entered into a strategic agreement focused on Auxogyn's proprietary Early Embryo Viability Assessment (Eeva) Test. Under the terms of the agreement, Merck Serono will provide strategic, scientific and medical support in the development and commercialization of the Eeva™ Test.
The Eeva™ Test can be fitted into most standard embryo incubators. It integrates a multi-well dish for embryos and a digital inverted time-lapse microscope with darkfield illumination. It utilizes intelligent computer vision software that analyzes embryo development, creating lab-based measurements that provide clinicians with information that can help assess embryo development.
Auxogyn received CE mark for the Eeva™ Test in July 2012, and it is currently available for use in select countries in the European Union. In the United States, a 510(k) application for the Eeva Test is currently under review by the U.S. Food and Drug Administration (FDA).
"Even with the great advancements in assisted reproductive technologies, clinicians have been using subjective observation to assess embryos," said Lissa Goldenstein, President and Chief Executive Officer of Auxogyn. "We hope that the Eeva™ Test will provide fertility clinics with access to a non-invasive computerized test that can help with decision making in the embryo selection process."
"As a global leader in the fertility field, Merck Serono's main objective is to invest in innovative science, medicines and technologies that deliver improved outcomes to patients throughout the IVF process," said Dr. Annalisa Jenkins, Executive Vice President, Head of Global Drug Development and Medical, Merck Serono. "Therefore, we are very pleased to be collaborating with Auxogyn to further support the clinical development of their Eeva™ Test technology."
Results from a prospective, multi-center clinical trial conducted to validate the clinical safety, efficacy and utility of the Eeva technology were presented in July 2012 at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting, in Istanbul, Turkey. In this cohort study, the Eeva™ Test was able to predict blastocyst formation at the cleavage stage with 85 percent specificity, reducing the false positive rate from 43 percent to 15 percent compared with traditional morphology selection. The positive predictive value was also improved from 34 percent to 55 percent. The Eeva™ Test also demonstrated the ability to track and analyze cell division timings with greater than 90 percent accuracy.