MENLO PARK, CA--(Marketwire - December 04, 2012) -
Auxogyn, Inc., a company focused on revolutionizing the field of reproductive health, today announced new data key to identifying which developing human embryos are the most likely to result in successful pregnancies during in vitro fertilization (IVF) procedures. The research, which was published in Nature Communications, suggests a link between fragmentation (a common occurrence in the early stages of human development) and the number of chromosomes in embryos. These findings could potentially be used to help select embryos with a high likelihood of being 'chromosomally normal' (having the correct number of chromosomes), which is important as an abnormal number of chromosomes can result in miscarriage.
The study utilized the technology behind Auxogyn's flagship product, the Early Embryo Viability Assessment (Eeva) Test and was conducted by Renee A. Reijo Pera, Ph.D., and colleagues at Stanford University. Auxogyn is the exclusive licensee of the intellectual property from Stanford University for this research.
"More than half of cleavage-stage human embryos carry an abnormal number of chromosomes, which can result in miscarriage," said Dr. Reijo Pera, professor of gynecology and obstetrics at Stanford University. "Using non-invasive, time-lapse imaging technology, we were able to distinguish between embryos with a normal number of chromosomes and those with an abnormal number of chromosomes. This discovery could contribute to improvements in IVF outcomes by potentially reducing the inadvertent transfer of embryos that would most likely result in miscarriage."
"Auxogyn is committed to investing in research to better understand the biology of human embryo development to improve outcomes for IVF patients," said Lissa Goldenstein, president and chief executive officer of Auxogyn. "Dr. Reijo Pera's research is an important advance in the field of IVF and demonstrates the potential of the technology in Eeva to further scientific understanding of human embryo development."
Study Design and Results
In the study, Dr. Reijo Pera and colleagues used non-invasive time-lapse imaging (the basis of the Eeva Test) to determine if dynamic human embryonic blastomere behavior might provide a means to distinguish euploid (normal number of chromosomes) from aneuploid (abnormal number of chromosomes) embryos. The researchers found precise cell cycle parameter timing in all euploid embryos. However, cell cycle parameter values within normal timing windows were found in only 30 percent of aneuploid embryos. The research suggests that fragmentation is often, but not always, associated with a lethal loss or gain of genetic material in embryo cells. By coupling an analysis of fragmentation with the timing of the major steps of embryonic development, the researchers were able to significantly increase the chances of selecting an embryo with the correct number of chromosomes, which is important since an abnormal number of chromosomes can result in a miscarriage.
These results extend previous findings published in Nature Biotechnology in October 2010. That research, also conducted by Dr. Reijo Pera and colleagues, indicated that the timing of cell division and other developmental milestones as the embryo progresses from one to four cells can be used to predict whether the embryo is likely to go on to develop to a blastocyst -- a key milestone in embryo development that is an important indicator that an embryo might result in a successful pregnancy.
Infertility affects one out of every six couples. The demand for assisted reproduction tools and procedures is growing by approximately 10-15 percent per year worldwide due to higher infertility rates caused by an increasing maternal age as more women are starting families later in life. The demand is growing despite the significant cost per cycle and the low success rate with approximately one-third of cycles resulting in a live birth. This often leads to the transfer of multiple embryos and/or conducting multiple cycles, leading to greater physical, emotional, practical and financial costs, before determining if pregnancy can be achieved.
About the Eeva™ Test
Auxogyn's non-invasive Eeva Test uses intelligent computer vision software to measure key parameters from video images and predicts, at the cleavage stage, which embryos will likely grow to the blastocyst stage. The Eeva Test is designed to improve IVF outcomes by providing clinicians and patients with objective information that will enable them to more confidently select embryo(s) for transfer. Eeva's proprietary software automatically analyzes embryo development against scientifically and clinically validated cell-division parameters, not only providing novel quantitative information, but also ensuring consistent measurements to assess embryo development versus the manual methods used today in clinical practice. With Eeva's quantitative data for each embryo's potential development, IVF clinics may be able to optimize the treatment path for their patients undergoing IVF procedures.
In July 2012, Auxogyn received CE mark approval for the Eeva Test, which is currently available for use in the European Union. It is not yet cleared in the United States, where it is limited to investigational use only. For more information regarding Eeva, please visit www.eevaivf.com.
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.