DARMSTADT, Germany,
June 10, 2014 /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®) 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
- 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
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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
€ 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.
