Merck Serono Introduces New Eeva Test Version Aiming for Optimized Assisted Reproductive Outcomes

PR61033

DARMSTADT, Germany, Jun. 30 /PRN=KYODO JBN/ --

    - 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.

    (Logo: http://photos.prnewswire.com/prnh/20150526/747165-b )

    (Logo: http://photos.prnewswire.com/prnh/20150611/748651-a )

    "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 model. 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.

    For more information, please visit http://www.merckserono.com

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    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.

SOURCE: Merck Serono