Merck Serono, the biopharmaceutical division of Merck, and Auxogyn, a company focused on translating scientific discoveries in early embryo development into clinical tools, have entered into a strategic agreement focused on Auxogyn's proprietary Early Embryo Viability Assessment (Eeva) Test.
Merck Serono will provide strategic, scientific and medical support in the development and commercialization of the Eeva Test.
"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 Annalisa Jenkins, executive vice president, head of global drug development and medical, Merck Serono.
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.
"Even with the great advancements in assisted reproductive technologies, clinicians have been using subjective observation to assess embryos," said Lissa Goldenstein, president and CEO 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."
Results from a prospective, multi-center clinical trial conducted to validate the clinical safety, efficacy and utility of the Eeva technology were released in July 2012. In this cohort study, the Eeva Test was able to predict blastocyst formation at the cleavage stage with 85% specificity, reducing the false positive rate from 43% to 15% compared with traditional morphology selection. The positive predictive value was also improved from 34% to 55%. The Eeva Test also demonstrated the ability to track and analyze cell division timings with greater than 90% accuracy.
Auxogyn received CE mark for the Eeva Test in July 2012, and it is currently available for use in select countries in the E.U. In the U.S., a 510(k) application for the Eeva Test is currently under review by the FDA.