Data Demonstrate ViaMetrics-E Improves Implantation Rates in Single Embryo Transfer IVF Cycles, A Growing Trend in Infertility Treatment

ROME and NORWOOD, Mass., June 28 /PRNewswire/ -- Researchers from Molecular Biometrics, Inc. presented new data this week demonstrating that the company's ViaMetrics-E procedure more accurately predicts implantation rates in single embryo transfer (SET) cycles for patients undergoing infertility treatment. ViaMetrics-E  is a rapid, non-invasive procedure used to enhance in vitro fertilization (IVF) outcomes by identifying viable embryos having the greatest reproductive potential. These research findings were presented this week at the 26th annual meeting of the European Society for Human Reproduction and Embryology (ESHRE) in Rome.

ViaMetrics-E is now available commercially in select countries in Europe, Asia and the Pacific Rim. The company expects to launch the product in other countries in Europe and Asia later this year. Molecular Biometrics is currently working to complete the necessary regulatory requirements to market the product in the U.S.

"Single embryo transfer is a significant and growing trend in infertility treatment in many countries, designed to help reduce the number of multiple births, and the costs and complications associated with them. Providing infertility specialists with greater confidence in identifying the best embryo(s) for transfer clearly supports this growing worldwide clinical focus," said James T. Posillico, Ph.D., President and Chief Executive Officer, Molecular Biometrics. "ViaMetrics-E, when used in conjunction with morphology -- the standard visual assessment of embryos -- gives infertility specialists a valuable new tool to more accurately predict implantation rates while reducing the potential of multiple births. Molecular Biometrics believes this is beneficial for patients, infertility specialists and the healthcare system overall."

Data described in a podium presentation delivered by Denny Sakkas, Ph.D., Adjunct Associate Professor, Yale University School of Medicine, Director of the Embryology Laboratory at Yale Fertility Center, and Molecular Biometrics' Chief Scientific Officer, indicate that differences in ViaMetrics-E Viability Scores could have an impact on which embryo to transfer in a patient's individual IVF cycle, and increase the potential for a successful pregnancy. Each Viability Score reflects the "health" or reproductive potential of the developing embryo.  

In this study, spent culture media from 439 embryos from 114 patients were analyzed. Results of this study showed that Day 5 embryos of similar morphology recorded a wide variation in Viability Scores. The data further show that Day 5 embryos with the best morphology within the cohort had the best Viability Scores in only 26% of the cases, indicating that, in 74% of cases, a different embryo may have been identified for transfer using ViaMetrics-E. The authors concluded that choosing embryos with the best metabolic profiles within a cohort, in addition to morphology, could have a significant impact on the identification of the best embryos for SET.

"Because only one embryo is transferred during a single embryo transfer, identifying the embryo with the greatest reproductive potential is critical," added Sakkas. "The non-invasive assessment of embryo culture using ViaMetrics-E technology can give clinicians greater confidence in identifying embryos with the highest potential for successful implementation, directly supporting the greater adoption of SET."

Results from two other studies presented at the ESHRE conference further demonstrated the role ViaMetrics-E might play in identifying the best embryo for single embryo transfer.

Data presented by Emre Seli, M.D., Associate Professor of Reproductive Endocrinology and Infertility at Yale University School of Medicine and Chair of Molecular Biometrics' Scientific Advisory Board, compared the assessment of morphology, Viability Scores produced by ViaMetrics-E and a combination of morphology and Viability Scores in the evaluation of an embryo's reproductive potential (determined by an embryo's positive and negative fetal cardiac activity (FCA) at 12 weeks of gestation). Analysis of 209 spent embryo culture media samples collected following Day 5 SET cycles from five IVF centers in the U.S., Europe and Australia indicated that a ViaMetrics-E Viability Score more accurately predicts embryo implantation rates than does morphology alone. The authors concluded that metabolic assessment of an embryo could yield up to 15% better predictability than morphology alone.

Data presented by Lucy Botros, M.Sc., Molecular Biometrics, assessed the accuracy of ViaMetrics-E in predicting the implantation potential of individual embryos. In an international, multi-center study, 248 spent culture media samples from eight infertility centers in the U.S., Europe and Australia were collected following single embryo transfer on Day 2 (n=176) and Day 5 (n=72). The samples were then evaluated using pre-established algorithms. For both transfer days, as the Viability Score for samples increased -- indicating greater reproductive potential of an individual embryo -- so did the associated pregnancy rate (defined as fetal cardiac activity or FCA). The authors concluded that analysis of spent culture media using ViaMetrics-E can assist in the identification of embryos with the greatest reproductive potential.  

About ViaMetrics-E™

ViaMetrics-E is a rapid, non-invasive procedure for in vitro fertilization (IVF) designed to aid in the assessment of viable embryos with the greatest reproductive potential. As embryos develop they undergo specific metabolic changes and produce biological signals or "biomarkers" that are absorbed into the culture media that nourishes these cells. Using a highly sensitive method of biomarker identification (metabolomics), ViaMetrics-E then measures these signals in the spent culture media, creating a 'fingerprint' or biomarker profile to help determine embryo viability. Analysis can be performed in an infertility laboratory in just minutes. ViaMetrics-E provides objective assessment of viability without compromising the embryo, helping guide treatment options for patients undergoing IVF.

ViaMetrics-E is not currently cleared for use in the U.S. by the Food and Drug Administration.

About Molecular Biometrics®

Molecular Biometrics, Inc. is applying novel metabolomic technologies to develop accurate, non-invasive clinical tools for use in personalized medicine to evaluate normal biologic function in health and in disease, and for drug discovery and development. The company's proprietary technology is being applied in reproductive health, IVF and neurodegenerative disease (e.g., Parkinson's disease). Molecular Biometrics is headquartered in Norwood, MA, with research and development facilities in New Haven, CT. For more information, please visit www.molecularbiometrics.com.

Note: This press release contains forward-looking statements about the objectives, plans and future prospects of Molecular Biometrics®, Inc. These statements are based on the company's current expectations and are subject to a number of uncertainties and risks, and actual outcomes and results may differ materially. Accordingly, forward-looking statements should not be regarded as a representation or warranty by Molecular Biometrics or any third party that the company's objectives and plans will be achieved in any specific time frame, if at all.

SOURCE Molecular Biometrics, Inc.