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Merck Serono and Auxogyn Announce Collaboration on EEVA™ Test
--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--
Geneva, Switzerland, and Menlo Park, Calif., USA, October 18, 2012 – 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.
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 Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurodegenerative diseases, oncology and rheumatology.
Merck is a global pharmaceutical and chemical company with total revenues of €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 free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.