Merck Serono Announces FDA Clearance for Auxogyn's Early Embryo Viability Assessment (Eeva®) System

Darmstadt, Germany (ots/PRNewswire) -

- FDA clearance validates Eeva System, which enables in-vitro fertilization
(IVF) clinicians to offer the proprietary Eeva Test and further demonstrates
commitment by Merck Serono and Auxogyn to bring innovative technologies to the IVF
community
- Eeva Test first-of-a-kind prognostic, non-invasive test that provides IVF
clinicians objective information regarding embryo development to help optimize
treatment plans for their patients

Merck Serono, the biopharmaceutical division of Merck, today
announced that the proprietary Early Embryo Viability Assessment
(Eeva(R)) System of Merck Serono's strategic partner Auxogyn received
clearance from the U.S. Food and Drug Administration (FDA) through
its de novo classification process, a regulatory pathway for select
novel, low-to-moderate risk medical devices that are first-of-a-kind.
Merck Serono is the exclusive commercial partner of Auxogyn, Inc.,
for the Eeva System in Europe and Canada.

The Eeva Test, used adjunctively to traditional morphology, is the
first and only prognostic, non-invasive embryo test to receive
clearance from the FDA. The Eeva Test utilizes proprietary software
that automatically analyzes embryo development against scientifically
derived cell-division timing parameters captured through continual
video imaging. This objective information provided to reproductive
endocrinologists and embryologists helps to optimize treatment plans
for their patients.

"The FDA clearance of the Eeva System reinforces the value of the
applicability of the Eeva Test in the IVF lab and may improve IVF
outcomes. It marks another significant and exciting milestone in our
continued collaboration with Auxogyn to further support the clinical
development and commercialization of their Eeva Test," said Meeta
Gulyani, Head of Strategy and Global Franchises at Merck Serono. "We,
therefore, welcome this further validation for the potential of the
Eeva Test to objectively identify the embryos with the highest
implantation potential, which may ultimately improve patient
outcomes."

The Eeva System received the CE Mark in 2012 and has been
commercially available in the European Union ever since, and more
recently in Canada since 2013. The potential of the Eeva System led
to an expansion of the original partnership agreement to include a
licensing agreement between Merck and Auxogyn, announced in April
2014 for the exclusive rights to commercialize the Eeva Test in
Europe and Canada. Auxogyn plans to commercialize the Eeva Test in
the United States later this year.

"We're excited to receive the de novo FDA clearance for the Eeva
System and believe this marks a significant milestone in the field of
IVF," said Lissa Goldenstein, president and CEO of Auxogyn. "We have
followed a rigorous, years-long clinical validation process and
regulatory pathway to bring the Eeva Test to market. Our clearance
provides a new level of confidence to IVF clinicians who, for the
first time, have quantitative information that can be used in
addition to traditional morphology to aid in deciding which embryo or
embryos to transfer."

According to the European Society of Human Reproduction and
Embryology (ESHRE), approximately five million additional babies have
been born worldwide since 1978 as a result of assisted reproduction
technologies (ART), like IVF.[1] This trend may increase due to
advancements in ART and IVF technologies such as the Eeva Test.

References

1) European Society of Human Reproduction and Embryology. (2012). The
world's number of IVF and ICSI babies has now reached a calculated total of 5 million
[Press release]. Retrieved from
http://www.eshre.eu/Press-Room/Press-releases/Press-releases-ESHRE-2012/5-million-babies.aspx

About Auxogyn

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 IVF clinicians and infertility patients can use
to make important treatment decisions. Auxogyn is privately held and
funded by Kleiner Perkins Caufield & Byers, MS Ventures, SR One and
TPG Biotech.

For more information regarding Auxogyn, please visit
http://www.auxogyn.com.

About Eeva

Auxogyn's non-invasive early embryo viability assessment (Eeva)
Test when used adjunctively to 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 cell-division timing
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.

Auxogyn received CE mark for Eeva in July 2012, and it is
currently available for use in selected countries in the EU.

For more information regarding Eeva, please visit
http://www.eevaivf.com.

About Merck Serono

Merck Serono is the biopharmaceutical division 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.

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
http://www.merckgroup.com/subscribe to register online, change your
selection or discontinue this service.

Merck is a leading company for innovative and top-quality
high-tech products in the pharmaceutical and chemical sectors. With
its four divisions Merck Serono, Consumer Health, Performance
Materials and Merck Millipore, Merck generated total revenues of EUR
11.1 billion in 2013. Around 38,000 Merck employees work in 66
countries to improve the quality of life for patients, to further 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 percent interest, the
founding family remains the majority owner of the company to this
day. Merck, Darmstadt, Germany is holding the global rights to the
Merck name and brand. The only exceptions are Canada and the United
States, where the company is known as EMD.

ots Originaltext: Merck Serono GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Your Contact: Bettina Frank, Phone +49-6151-72-4660