“Our growing body of research-based evidence is clearly demonstrating that our metabolomic technology can be used to improve the assessment of embryo viability,” said James T. Posillico, PhD, President and Chief Executive Officer, Molecular Biometrics. “Importantly, these most recent data show that our metabolomic profiling technology can also assess viability of blastocysts as well as frozen embryos in single embryo transfer cycles, an increasingly popular treatment option.”
“Single embryo transfer, or SET, is an effective way to minimize the risk of multiple births. But because only one embryo is transferred per cycle in SET, the selection of the embryo with optimal reproductive potential is essential so that overall IVF pregnancy rates do not suffer as a consequence,” Posillico added. “Together with a traditional morphology assessment, our metabolomic technology can aid in the rapid, non-invasive prediction of an embryo’s reproductive potential, with the goal of lowering multiple births while increasing pregnancy rates."
Predicting Embryo Viability in Day 5 Blastocysts
In a study entitled Non-invasive metabolomic profiling of Day 5 embryo culture media: Blinded cross clinic prediction of embryo viability using Near Infrared Spectroscopy, 89 single embryo transfer cycles were performed with Day 5 blastocysts. In this study, a predictive algorithm was trained to generate a “Viability Score” using 47 pre-selected embryo culture samples from a major infertility clinic in the U.S. and blindly validated on 42 samples from a clinic in Sweden.
When the transferred blastocysts were assessed in a blinded fashion, a significant positive correlation was observed between embryos’ increasing Viability Scores and their respective implantation rates (p<0.05).
Metabolomic Assessment of Cryopreserved Embryos
Several recent studies have demonstrated that metabolomic profiling of biomarkers of embryo metabolism using near infrared (NIR) spectroscopy correlated with ongoing pregnancy in fresh IVF/ICSI cycles. A second study presented at ESHRE, Viability assessment of cryopreserved embryos by Near Infrared Spectroscopy: preliminary results, evaluated the use of metabolomic profiling using NIR spectroscopy to determine ongoing pregnancy after SET with post-thaw embryos.
Day 4 embryos from 52 patients were selected using standard morphology criteria. Following transfer, using spent culture media, individual metabolomic profiles were obtained using the company’s embryo viability assessment procedure to establish Viability Scores. This procedure was able to significantly discriminate (p=0.007) between cryopreserved embryos that established ongoing pregnancies compared to those that failed to implant.
Metabolic Profiling in SET Cycles
A third study, Evaluation of metabolomic profiling as a tool for embryo selection in Single Embryo Transfer (SET), assessed the correlation between a metabolomic profile and morphological exam to evaluate the health of a developing embryo. In a retrospective analysis of 144 SET cycles, the company’s embryo viability assessment technology was used to determine Viability Scores based on the differences of metabolomic profiles between transferred embryos which did and did not result in implantation. Later stage embryos (4 cell) were more likely to have higher Viability Scores than embryos with 2 cells, indicating that metabolomic profiling may be a useful indicator for embryo selection, when used as an adjunct to morphology.
“While much progress has been made in selecting viable embryos, these new data demonstrate that a metabolomic profile unique to each embryo exists, and that this profile can more accurately establish viability of individual embryos,” Posillico stated. “We extend our thanks to the world-class researchers who participated in these studies, and look forward to further establishing our metabolomic technology to improve infertility treatment for patients.
Metabolomics at Molecular Biometrics
Metabolomics is a complex scientific process that identifies and measures individual signals from many small molecular compounds produced by cellular metabolism which, when evaluated systematically, represent unique biomarkers of biologic function in health and disease.
Molecular Biometrics developed a proprietary NIRS platform for its metabolomic applications. NIRS is a robust technology that rapidly measures the vibrational energy produced by small molecule functional groups, creating a unique profile of molecules that are reflective of cellular function and viability.
The spectral signatures are further analyzed by proprietary bioinformatics and chemometric algorithms that allows for the creation of a novel “metabolomic profile” or “fingerprint” that can be used to systematically 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.
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, and Montreal, Quebec. For more information, please visit www.molecularbiometrics.com.
