ATLANTA, GA, and NORWOOD, MA, OCTOBER 21, 2009 – Molecular Biometrics®, Inc. presented six new studies demonstrating a strong correlation between higher embryo Viability Scores (determined by the company’s novel metabolomic technology) and higher implantation rates of embryos in women undergoing in vitro fertilization (IVF). These blinded studies used pre-established algorithms to measure the viability of Day 2, 3 and 5 embryos in single embryo transfer (SET) cycles. The studies were presented in two oral presentations and four posters delivered this week at the 65th annual meeting of the American Society for Reproductive Medicine (ASRM).

“In numerous blinded studies, our ViaMetrics-E™ technology has shown great promise in evaluating the reproductive potential of individual embryos and could, ultimately, help to reduce the risk of multiple births in IVF,” said James T. Posillico, PhD, President and Chief Executive Officer, Molecular Biometrics. “By identifying the single embryo with the greatest reproductive potential from all the patient’s embryos in an IVF treatment cycle, physicians and patients will feel more confident transferring a single embryo to achieve pregnancy. This is in contrast to the current practice -- in the USA and certain other countries -- of transferring numerous embryos and thereby increasing the risk of having twins, triplets or even higher order multiples. Accurate embryo viability assessment should improve pregnancy rates and reduce the staggering costs and complications associated with multiple births.”

An oral presentation, Viability Scores Determined by Metabolomic Assessment of Embryo Culture Media Correlate with IVF Outcome in Women Undergoing Single Embryo Transfer on Day 5: A Prospective Multi-Center Study, concluded that there is a positive correlation between increasing Viability Scores and the reproductive potential of individual embryos in SET cycles (p<0.05). Using Day 5 spent embryo culture media from a total of 72 samples collected by Shady Grove Fertility Center (Rockville, MD, U.S.), Reproductive Science Center (Lexington, MA, U.S.), Sydney IVF (Sydney, Australia) and Fertilitetscentrum (Gothenburg, Sweden) demonstrated that Viability Scores determined by metabolomic profiling can be used, independent of morphological examination, for non-invasive assessment of embryo viability.

A second oral presentation, Successful Blinded Pregnancy Outcome Prediction of Day 5 Single Blastocyst Transfers by Non-Invasive Metabolomic Profiling of Embryo Culture Media Using Near Infrared (NIR) Spectroscopy, demonstrated that a pre-established Day 5 algorithm can significantly improve the ability to differentiate between embryos with high or low reproductive potential. In this study, Viability Scores were determined for embryo culture media samples collected from 73 SET cycles conducted at Sydney IVF (Sydney, Australia). There was a significant difference (p=0.0044) in mean Viability Scores among those embryos resulting in positive versus negative pregnancy outcomes.

“Metabolomic profiling is proving to be an important new technology for IVF. The ability to select a single embryo with the most favorable reproductive potential can help improve pregnancy rates and minimize the risk of multiple births,” added Denny Sakkas, PhD, Chief Scientific Officer at Molecular Biometrics Inc., Adjunct Associate Professor, Department of OB/GYN and Reproductive Sciences at the Yale University School of Medicine, and Director of Assisted Reproductive Technology Laboratories of the Yale Fertility Center.

During the ASRM annual meeting, Dr. Sakkas is serving as Chair of a Scientific Program on metabolomics, proteomics and genomics, and is a featured speaker at a post-graduate course on single embryo transfer.

In addition to the two podium presentations at ASRM described above, four poster presentations were presented at the conference that further demonstrate that metabolomic profiling can be used to improve the assessment of embryo viability.

Viability Scores Determined by Metabolomic Assessment of Embryo Culture Media Correlate with IVF Outcome in Women Undergoing Single Embryo Transfer on Day 2: A Prospective Multi-Center Study – Evaluating a total of 176 spent embryo culture media samples, researchers found that Viability Scores associated with embryos that resulted in pregnancy were significantly higher compared to those that failed to implant (p=0.011). Higher Viability Scores correlated well with increased reproductive potential of individual embryos, suggesting that the technology may constitute an important parameter for the non-invasive assessment of embryo viability. Samples for this study were collected by researchers at Unilabs Laboratoire D’Elyau (Paris, France), Väestöliitto Fertility Clinics (Helsinki, Finland), Fertilitetscentrum (Gothenburg, Sweden), and Royal Woman’s Hospital (Melbourne, Australia).

Blinded Pregnancy Outcome Prediction of Day 2 Single Embryo Transfer (SET) by Non-Invasive Metabolomic Profiling of Embryo Culture Media Using Near Infrared (NIR) Spectroscopy – Evaluating 45 spent embryo culture media samples, researchers found a significant difference (p=0.002) between mean Viability Scores for spent culture media samples from embryos that resulted in pregnancy versus those that failed to implant. In this study, the pre-established algorithm used in metabolomic profiling significantly improved the probability of predicting the reproductive potential of a single embryo.

As the Viability Scores increased, their associated pregnancy rates also increased. This study, conducted in collaboration with Väestöliitto Fertility Clinics (Helsinki, Finland), further supports that metabolic profiling can be used to augment morphological examination to predict pregnancy prior to SET.

Non-Invasive Metabolomic Profiling of Day 3 and 5 Embryo Culture Media Using Near Infrared Spectroscopy: Predictions Using Pre-Established Models – Pre-established algorithms used in metabolomic profiling of a total of 147 Day 3 and Day 5 spent embryo culture media samples predicted embryo implantation potential (p=0.013 and p=0.036, respectively). Researchers from Reproductive Science Center (Lexington, MA, U.S.) and Molecular Biometrics concluded from this study that metabolic profiling could help clinics in the U.S. move toward SET.

Near-Infrared (NIR) Analysis of Day 2 Embryo Culture Media from the Cohort of Patients Morphologically Good Grade Embryos – In this study, researchers from Kato Ladies Clinic (Tokyo, Japan) and Molecular Biometrics found that Viability Scores vary widely within a patient’s cohort of good embryos (grades 1 and 2), suggesting that metabolic profiling could have a significant impact on improving the chances of selecting the most viable embryo within a cohort of embryos from a single patient. The researchers concluded that using this metabolic parameter could greatly improve the chances of identifying the most viable embryo for transfer, even among morphologically good grade embryos.

In all six studies, pregnancy was confirmed by fetal cardiac activity (FCA), a common early (12 weeks gestation) indicator of pregnancy.

“Following a successful beta testing program in Europe, Australia and Japan, Molecular Biometrics is preparing for the commercial launch of the ViaMetrics-E embryo viability assessment technology later this year in several countries outside the U.S.” added Posillico. “We are grateful to the researchers and IVF centers around the globe that have participated in of our clinical research programs.”

Metabolomics is a complex scientific process that identifies and measures individual signals from many small molecular compounds produced during cellular metabolism. The company’s novel technology platform creates a ‘metabolomic profile’ or ‘fingerprint’ of an embryo’s potential viability, prior to possible embryo transfer in an IVF cycle. Metabolomic profiling provides a simultaneous evaluation of large numbers of biomarkers that reflect embryo development in culture media.

Molecular Biometrics developed a proprietary NIR (near infrared) biospectroscopy platform for its metabolomic applications. This technology rapidly measures the vibrational energy ‘signatures’ produced by small molecule functional groups, creating a unique profile of molecules that are descriptive of cellular function and viability.

The signatures are further analyzed by proprietary bioinformatics, which evaluates the biological and chemical data produced by NIR biospectroscopy, using sophisticated computer and statistical techniques to distinguish between the often subtle differences that separate normal physiology from the onset or progression of disease, or an individual’s response to therapeutic intervention.

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, and Montreal, Quebec. For more information, please visit www.molecularbiometrics.com.

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