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Metabolomic Profiling Accurately Selects Viable Embryos for In Vitro Fertilization

Posted on: Wednesday, 25 October 2006, 09:00 CDT

Molecular Biometrics, a privately held metabolomics company, presented results of two clinical studies investigating the use of metabolomic profiling to assess embryo viability, a key step in the treatment of infertility by in vitro fertilization (IVF), at the American Society of Reproductive Medicine's 62nd Annual Meeting in New Orleans, LA.

In a podium presentation (O-270) titled Non-Invasive Metabolomic Profiling of Human Embryo Culture Media Correlates with Pregnancy Outcome, Principle investigator Emre Seli M.D., Ph.D. (et. al.) of the Metabolomic Study Group in ART at Yale University School of Medicine reported results of a retrospective multi-center study. The study was designed to assess embryo viability using a novel technology developed by Molecular Biometrics based on the metabolomic profiling of Oxidative Stress (OS) biomarkers. The goal of the technology is to identify metabolomic differences in viable verses non-viable embryos so only the highest quality embryos can be selected for transfer in IVF. This non-invasive test analyzes OS biomarkers in normally discarded culture media. The biomarkers are quantified using Molecular Biometrics' proprietary spectroscopic analysis and advanced bioinformatics.

The study group concluded that detectable differences exist in the metabolomic profiles found in culture media obtained from embryos that cause pregnancy compared to those that do not. The reported metabolomic parameters were established using two different forms of spectroscopic analysis, Raman and Near Infrared (NIR) spectroscopy, with media samples obtained from three different IVF programs. The metabolomic method achieved high sensitivity and specificity of > 85%.

James Posillico, Ph.D., President and CEO of Molecular Biometrics commented on the study, "There are currently no available biological metrics that allow embryologists to effectively distinguish between viable and non-viable embryos in a cohort group prior to selection in IVF. Achieving a live birth typically requires three or more IVF treatment cycles, each with multiple embryo transfers. The goal of our technology is to offer an objective method of viable embryo selection that will allow IVF practitioners to reduce the number of embryos transferred without compromising pregnancy rates."

Dr. Posillico continued, "These encouraging results suggest that non-invasive metabolomic profiling of embryo culture media may soon provide embryologists with a new tool for the accurate selection of viable embryos capable of producing a pregnancy and the elimination of those that will not. Such a breakthrough could give IVF practitioners a reliable method of embryo selection that would lead to a reduction in the number of embryos transferred in each treatment cycle. This, in turn, would likely result in a reduction in the high number of multiple births and associated premature deliveries that are commonly observed in IVF."

In the study, embryo culture medium from 163 embryos from assisted reproductive technology (ART) cycles using fresh donor and nondonor oocytes were evaluated. Normally discarded media from individually cultured embryos was collected at the time of embryo transfer on day 3, and analyzed using both Raman, and Near Infrared Spectroscopy. Metabolomic profiles of OS biomarker concentrations showed distinct differences between culture media of embryos that resulted in pregnancy compared to those that did not. Using a genetic algorithm with Raman analysis, novel OS molecular species were identified and statistically correlated with pregnancy outcome. The compiled outcomes resulted in a specificity of 82% and sensitivity of 95%. Likewise, analysis by NIR resulted in a specificity of 83% and sensitivity of 73%.

Complex interactions between the pro-oxidants and antioxidants are crucial in the maintenance of normal intracellular homeostasis. An imbalance in these reactions results in OS, which is known to affect the quality of spermatozoa, eggs and embryos. Current analytical methods that assess OS rely primarily on biochemical methodologies that are cumbersome, costly and labor intensive. The advent of metabolomic profiling will likely offer an accurate method of viable embryos selection.

Separately, in a poster presentation (P-271) titled A prospective blinded evaluation of the relationship between metabolomic profiling of spent embryo culture media and human embryonic reproductive potential, Principle investigator Richard Scott, M.D., Ph.D., (et. al.) of Reproductive Medicine Associates of New Jersey presented results of a blinded prospective study designed to determine if metabolomic profiling of embryonic development using biospectroscopy-based metabolomics could be used to identify and select viable embryos for transfer in IVF.

In this study, individual media samples representing sixty-five embryos selected for transfer in IVF were evaluated. There were significant differences in the spectral scores between those embryos which implanted and those which did not (P=0.003). The scores were then regrouped by patient with each subject being assigned the mean of the scores of their individual embryos. There was a significant difference between those patients whose embryos were reproductively viable (100% sustained pregnancy) and those embryos that were not viable (0% pregnancy) (P=0.01).

The study group concluded that there is a clear relationship between the reproductive potential of human embryos and their modification of the media in which they have been cultured. These subtle modifications can be detected using Molecular Biometrics' biospectroscopy-based metabolomic profiling.

About Molecular Biometrics:

Molecular Biometrics is a privately held metabolomics company that has developed a novel technology platform based on breakthrough metabolomic and biospectroscopy sciences. These disciplines are used in concert to quantify a sample's molecular biomarker makeup and then convert that data into a novel "metabolomic profile" of health or disease using highly specific and sensitive bioinformatics. Molecular Biometrics' technology platform has broad applications in numerous therapeutic categories, including fertility, maternal fetal medicine, neurodegenerative disease such as Alzheimer's and Parkinson's disease and pulmonary and lactate metabolism. The Company's technology platform will also be used to develop a new family of molecular diagnostics products and has applications in pharmacodiagnostics of drug discovery and development.

Molecular Biometrics' lead product candidate is a rapid, non-invasive test of embryo viability for the in vitro fertilization (IVF) market, where embryo selection is a pivotal step in the treatment procedure. The Company's cost-effective platform enables identification and simultaneous analysis of multiple small molecule biomarkers, in a single sample, leading to the accurate detection of viable embryos in a cohort group that are capable of producing a pregnancy versus those that will not. This high-speed procedure takes approximately one minute to complete.

Please visit Molecular Biometrics' during ASRM at booth #335.

[Editor's Note: Study abstracts available by visiting http://dbpub.com/lookup/ASRM2006/default.php]

 Contact:  Bryan P. Murphy LaVoie Group 978.745.4200 x 105 Contact via http://www.marketwire.com/mw/emailprcntct?id=F17038A61D33F2C6  

SOURCE: Molecular Biometrics

Source: MARKET WIRE

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