Not intended for US based media Merck Serono continues to provide health care professionals with innovative fertility technologies that aim to improve embryo assessment during ART cycles The new Eeva Test 2.3 features the Xtend Algorithm, utilizing new parameters to capture a more complete picture of embryo development.Merck Serono, the biopharmaceutical business of Merck, today announced the launch of the new Eeva(R) (Early Embryo Viability Assessment) Test with the Xtend Algorithm, the advanced version of a non-invasive test to aid embryo assessment within assisted reproductive treatment (ART). The new version builds upon the scientific and clinical record of Merck Serono’s established Eeva System and utilizes a new algorithm to provide a multi-dimensional model for assessing and predicting the development of embryos. The advanced Xtend Algorithm enables ART labs to capture a more complete picture of embryo development and – when used adjunctively with traditional morphology – increases the chances of identifying embryos that have the highest developmental potential compared to traditional morphology alone. With the launch of the improved system, Merck Serono further expands its portfolio in fertility technology which is becoming increasingly important to improve fertility treatment outcomes.
“Introducing the Eeva System 2.3 and its Xtend Algorithm shows our commitment to continuous innovation to ultimately improve success rates in ART,” said Meeta Gulyani, Head of Global Strategy and Franchises at Merck Serono. “We see strong opportunities for scientific innovation in fertility technologies and will continue to invest in developing new products and evolving existing ones, such as the Eeva Test. As the world’s leader and pioneer in fertility treatment, we are drawing upon our strong heritage in the field to further support IVF clinicians in helping women and couples realize their dream of welcoming a baby to their family.”
The Eeva System uses automated image analysis software to capture and analyze embryo cell activity that the human eye is not capable of detecting, providing objective and consistent test results for ART clinicians. Building upon the robust scientific foundation of its established predecessor, the improved Eeva System 2.3 includes a new multi-dimensional algorithm to address the demand for more objectivity and standardization within ART and optimized outcomes. The Xtend Algorithm was identified through a rigorous R&D process, which investigated over 1,000 potential parameters before determining the most relevant ones for improving the chance of identifying the embryos with the highest potential of ART success if used adjunctively with traditional morphology. Extending beyond measurement of cell division timings, the Xtend Algorithm includes additional parameters, leading to five parameters overall that are applied to each embryo and mapped against a multi-dimensional prediction mo
del. The Xtend Algorithm was developed on a large data set from 12 sites, 373 women and 3,328 embryos, and validated on an independent data set to demonstrate objective and consistent test results. The Eeva System 2.3 further provides a new five-tier classification system, designed to offer more assessment options to better distinguish the embryo with highest developmental potential when used adjunctively with traditional morphology.
About the Eeva Test
The non-invasive Early Embryo Viability Assessment (Eeva(R)) Test when used adjunctively with traditional morphology may improve IVF outcomes by providing IVF clinicians and patients with objective information on embryo viability. The Eeva System utilizes proprietary software that automatically analyzes embryo development against scientifically and clinically validated parameters. With Eeva’s quantitative data on each embryo’s potential development, IVF clinicians can optimize the treatment path for their patients undergoing IVF procedures.
Progyny, Inc. formed March 2015 is the combined entity of Auxogyn, Inc. and FertilityAuthority, LCC. In March 2014, Auxogyn Inc. granted Merck Serono exclusive rights to commercialize Auxogyn’s proprietary Early Embryo Viability Assessment (Eeva) Test in Europe and Canada, with the option to extend to selected countries. Progyny retains the commercial rights to the Eeva Test in the United States. The agreement is the latest development in the ongoing collaboration between Merck Serono and Progyny, which began in 2010 when Merck invested in Auxogyn through its corporate venture capital fund, MS Ventures.
Auxogyn received the CE mark for Eeva in July 2012, and at the end of the first half of 2015, Merck will have launched the test in 13 countries across Europe and Canada. In the United States, clearance for the Eeva System was granted by the U.S. Food and Drug Administration through its de novo classification process in June 2014.
About Merck Serono
Merck Serono is the biopharmaceutical business of Merck. 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 neurology, oncology, immuno-oncology and immunology.
Merck is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials – and generated sales of around EUR 11.3 billion in 2014. Around 39,000 Merck employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
