ROCKLAND, MA and MENLO PARK, CA--(Marketwire - October 18, 2012) -
- The Early Embryo Viability Assessment (Eeva) Test is designed to provide data that will help assess embryo viability
- Strategic partnership demonstrates Merck Serono's commitment to investing in assisted reproductive technologies
EMD Serono, a subsidiary 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, EMD 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, EMD 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, a division of Merck KGaA, Darmstadt, Germany. "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.
Auxogyn is revolutionizing the field of reproductive medicine by translating scientific discoveries in early embryo development into clinical tools. The Company's flagship product, the Eeva™ Test, delivers consistent, objective and quantitative information regarding embryo viability that reproductive endocrinologists and infertility patients can use to make important treatment decisions. Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech. For more information regarding Auxogyn, please visit www.auxogyn.com.
About EMD Serono, Inc.
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, endocrinology and in reproductive health. In addition, EMD Serono is growing its expertise and presence in the area of oncology, with more than 15 projects currently in development. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with approximately 1,000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.
For more information, please visit www.emdserono.com
About Merck KGaA
Merck is a global pharmaceutical and chemical company with total revenues of EUR 10.3 billion in 2011, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
For more information, please visit www.merckserono.com or www.merckgroup.com