|By Marketwire .||
|October 22, 2012 09:00 PM EDT||
SAN DIEGO, CA and MENLO PARK, CA -- (Marketwire) -- 10/22/12 -- Auxogyn, Inc., a company focused on revolutionizing the field of reproductive health, today announced two presentations describing new data from a prospective, cohort study conducted at multiple independent centers. One presentation showed that Auxogyn's flagship product, the Early Embryo Viability Assessment (Eeva) Test, could predict which cleavage-stage embryos would successfully develop to viable blastocysts by Day 3 of in vitro fertilization (IVF) with high specificity and consistency. The second presentation showed that the use of Eeva in combination with traditional morphology significantly improved embryo selection accuracy compared with morphology alone. The data were presented today in oral sessions during the ASRM Annual Meeting in San Diego. Three additional data presentations on Eeva will be presented at the meeting over the remainder of the week. The Eeva Test uses intelligent computer vision software to measure key parameters from video images and predicts with high accuracy at the cleavage stage which embryos will likely grow to the blastocyst stage.
"Eeva provides a new tool to investigate an old problem by collecting accurate quantitative information about early embryo development," said Philip Chenette, M.D., medical director at the Pacific Fertility Center (PFC) in San Francisco. "This technology provides new insights that help improve embryo selection and potentially improve IVF outcomes and pregnancy rates. Eeva technology aligns with PFC's goals to maximize pregnancy rates with minimum risk, helping patients build families, one healthy baby at a time."
"The IVF field has seen many technologies emerge to improve embryo selection, but Auxogyn has set itself apart through the rigorous validation of the safety, efficacy and practical utility of Eeva," said Lissa Goldenstein, president and chief executive officer of Auxogyn. "Auxogyn is committed to continuing to build on the robust body of evidence supporting Eeva through comprehensive clinical science in real-world settings. This is evidenced by the wealth of data being presented at the ASRM meeting, which demonstrates that the use of Eeva not only predicts embryo advancement with increased accuracy, but also provides embryologists with quantitative information to improve embryo selection for transfer."
Eeva Study Design and Results
The presentation titled, "Prediction of Embryo Viability Using Validated Cell Division Time Intervals Measured by Time-Lapse Imaging," was based on a study conducted to prospectively validate Eeva's ability to predict viable blastocyst formation by the cleavage stage, and assess Eeva's prediction consistency for separate patient populations. Results showed that Eeva was able to predict blastocyst development with a specificity of 85 percent for a group of 75 patients (941 embryos) and 82 percent for a separate group of 36 patients (349 embryos). The specificities for both patient sets were significantly improved compared to the average specificity of predictions made by experienced embryologists using cleavage morphology (57 percent).
A second presentation titled, "Improved Embryo Selection Accuracy Using Cell Division Characteristics Defined by Time-Lapse and Automated Image Analysis," included 54 patients undergoing IVF (755 embryos) and evaluated the degree of improvement to viable embryo selection when using Eeva with traditional morphology. In the study, three experienced embryologists made a "blastocyst" or "arrest" prediction for each embryo using Day 3 morphology only, and then using morphology plus Eeva. Eeva provided a score of "low" or "high" probability to develop to blastocyst. Predictions were noninvasive and available by early morning of Day 3 using Eeva. When the prediction results were compared with true blastocyst outcomes, results showed that adding Eeva to traditional morphology dramatically improved Day 3 blastocyst prediction specificity for each embryologist. Further, the variability among embryologists was significantly reduced.
Additional Eeva Study Results To Be Presented at ASRM
Additional data on Eeva being presented during the ASRM Annual Meeting include:
- Evaluation of Eeva videos of transferred embryos with "good morphology" and assessment of the relationship between Eeva cell division parameters and implantation outcomes will be presented by Joe Conaghan, Ph.D., in a video symposium on Tuesday, October 23 from 11:18-11:26 a.m. ("Embryos with Good Morphology but Abnormal Cell Division: Would You Transfer These if You Knew?")
- A review and discussion of time-lapse imaging in clinical embryology will be presented by Joe Conaghan, Ph.D., in the ASRM Imaging in Reproductive Medicine and the ChsIG Interactive Session on Tuesday, October 23 from 1:15-2:15 p.m. ("Imaging of the Embryo vs. Imaging of the Embryo Transfer for Maximizing Pregnancy Rates")
- Results of the prospective, multicenter study that validated the automated computer vision algorithm that provides consistent, real-time predictions of embryo viability and aids embryologists in improving embryo selection will be presented in a poster session on Wednesday, October 24 from 7:00-9:00 a.m. ("Development and Validation of an Automated Computer Vision Algorithm for Real-Time Embryo Viability")
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 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.