Embryo Viability Studies Support Utility of Novel, Metabolomic Profiling Technology

Molecular Biometrics presents scientific evidence supporting accuracy of its biospectroscopy-based metabolomics platform at major international conference. BARCELONA, Spain and CHESTER, N.J., July 7


BARCELONA, Spain and CHESTER, N.J., July 7 /PRNewswire/ -- Molecular
Biometrics, LLC, a privately-held metabolomics company developing novel
clinical tools for applications in personalized medicine to more accurately
characterize biologic function in health and disease, presented data from four
new studies evaluating the benefits of metabolomic profiling to determine
embryo viability and enhance in vitro fertilization (IVF) outcomes.  These
study findings, presented this week at the 24th annual Meeting of the European
Society for Human Reproduction and Embryology (ESHRE), include perspectives in
evaluating oocytes (eggs), embryos and blastocysts (late stage embryos) to
determine embryo viability using the company's novel, proprietary technology.


"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," said James T. Posillico, PhD, President and Chief
Executive Officer, Molecular Biometrics.  "Using highly sensitive metabolomic
technology, we can accurately and non-invasively measure these signals in the
culture media, creating a 'fingerprint' or biomarker profile to help determine
embryo viability.  We believe this technology may hold significant potential
to more accurately estimate reproductive potential of individual embryos,
thereby increasing IVF success rates."


"We are grateful to the researchers and IVF clinics worldwide who are
participating in this important clinical research," Posillico added.  "We have
initiated additional studies to further validate this technology and to
explore altogether new applications in IVF."



Metabolomic Viability Scores and Implantation Rates


Currently, visual assessment of embryo morphology alone is used to
determine reproductive potential of embryos for implantation in an IVF
procedure.  In a multi-center study, "A viability index determined by non-
invasive metabolomic profiling of embryo culture media correlates with ART
outcome," researchers determined that a 'viability index' generated using
Molecular Biometrics' metabolomic technology to assess the chemical
composition of the culture media surrounding an embryo can discriminate among
embryos of the same morphology.


This indicates that the metabolism of the embryo -- and therefore, its
reproductive potential -- does not necessarily correlate with morphology.


The company's metabolomics technology was used to determine a viability
score for embryos of different morphology grades that did or did not result in
pregnancy after single embryo transfer.  Viability scores obtained by
metabolomic profiling correlated with pregnancy outcomes in a manner that was
significantly greater than that achieved by morphology.



Oocyte Profiling Predicts Embryo Viability


In a second study, "Metabolomic profile of human oocyte is predictive to
embryo development and viability," researchers demonstrated that metabolomic
profiling from spent culture media of an oocyte is able to predict embryo
development at Day 3 and 5, and may also predict overall embryo viability.
Just three hours of individual oocyte culture proved sufficient to produce
metabolomic "fingerprints" that could predict embryo development and
viability.


"These data are very promising, and demonstrate that metabolomic profiling
may prove to be a useful methodology for rapid, non-invasive oocyte and embryo
assessment," added Denny Sakkas, PhD, Associate Professor, Department of
OB/GYN and Reproductive Sciences at the Yale University School of Medicine,
Director, Assisted Reproductive Treatment Laboratories, Yale Fertility Center,
and Chief Scientific Officer, Molecular Biometrics.  "The application of this
novel metabolomic technology may favorably impact IVF outcomes by improving
procedures to more accurately predict embryo viability and reproductive
potential.  Having the ability to reliably select viable embryos will allow
infertility specialists to reduce the number of embryos transferred in IVF and
thus decrease the incidence of multiple gestations."



Embryo and Blastocyst Profiling


Two other presentations -- "Metabolic modifications of culture medium by
human embryos; correlations with embryonic characteristics and outcome in
single embryo transfers," and "Non-invasive metabolic profiling of day 5 spent
culture media aids in the prediction of blastocyst viability" -- further
highlighted the potential applications of Molecular Biometrics' proprietary
metabolomic technology.  The first study demonstrated that embryos that
implant following transfer alter their culture media differently from embryos
that failed to implant.  These differences were readily detectable using the
company's metabolomics platform.  Viability scores, generated based on these
metabolomic differences, were significantly more accurate than currently-used
morphological measures in identifying viable embryos capable of implantation.
The second study determined that metabolomic profiling of blastocysts can also
be used to assess viability of these advanced stage embryos as well.



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 as a whole, represent unique biomarkers of
biologic function in health and disease.


Molecular Biometrics uses near infrared (NIR) biospectroscopy in its
metabolomic applications.  NIR is a robust platform that rapidly measures the
vibrational energy produced by small molecule functional groups, creating a
profile of molecules that are descriptive of cellular function and viability.


The spectral signatures are further analyzed by proprietary bioinformatics
and chemometrics that result in 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.  Metabolomics is commonly used in pharmaceutical research,
molecular diagnostics and food and agrichemical industries.



About Molecular Biometrics


Molecular Biometrics, LLC, 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 and IVF, neurodegenerative disease (e.g.,
Alzheimer's disease and Parkinson's disease), maternal fetal medicine,
pulmonary metabolism and edema, and lactate metabolism.  Molecular Biometrics
is headquartered in Chester, NJ, with research and development facilities in
New Haven, CT, and Montreal, Quebec. For more information, please visit
www.molecularbiometrics.com.



SOURCE  Molecular Biometrics, LLC