molecular biometrics  
Reproductive health and Fertility

Reproductive Health
and Infertility

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Overview
In the field of Assisted Reproductive Technology (ART), one of the most significant goals in the treatment of infertility is decreasing multiple gestations while maintaining or improving overall pregnancy rates. Poor embryo quality can be caused by metabolic errors, fragmentation and other cellular deficiencies that are known to compromise embryo development and, at the follicular level, are associated with poor oocyte viability.

Today, due to the lack of effective diagnostic procedures, IVF treatments that (unknowingly) start with genetically defective eggs are likely to be compromised. This problem will continue to impact infertility treatment outcomes until biologically competent oocytes (and embryos) can be selected from their non-viable cohorts.

New technology that is capable of selecting only competent oocytes and embryos in an IVF program should lead to markedly improved treatment outcomes and success rates. An important additional benefit - safety - should also be realized since selective use of only viable, competent embryos means fewer embryos are needed for transfer, thus reducing the risk of multiple births. By selecting only the most viable embryos, this technology can also help to minimize the number of IVF treatment cycles needed to achieve a healthy pregnancy, while reducing patient cost.
The non-invasive assessment of gamete and embryo reproductive potential has been the “holy grail” of IVF.

The Molecular Biometrics Solution
To address this critical need in infertility treatment, Molecular Biometrics has developed an accurate, non-invasive procedure to assess embryo viability in an IVF laboratory – ViaMetrics-E™.

During embryo culture, and at the time of embryo selection prior to transfer, culture media that baths the embryo can be analyzed using ViaMetrics-E™ to assess embryo reproductive potential or viability. All culture samples used in our proprietary metabolomic profiling are excess specimens that are either discarded or stored after IVF; only small sample volumes are required for analysis (7μl). The instrument needed to perform these sophisticated analyses has been engineered to be reliable, cost effective, and user-friendly. The Company’s proprietary bioinformatics rapidly captures and analyzes multiple biomarker data and performs high-speed computations that produce results in about one minute.

Enabling Single Embryo Transfer (SET)
Reducing the number of embryos transferred will logically lead to a reduction in the number of multiple births. The goal of IVF practitioners, patients, the American Society for Reproductive Medicine (ASRM) and insurance providers alike is to achieve a reduction in the multiple birth rate without compromising pregnancy rates. Unfortunately, this has proven to be an elusive goal because of the limitations of the current embryo selection process. The availability of metabolomic profiling is expected to empower practitioners to eventually move from multiple embryo transfer to single embryo transfer (SET) as the new paradigm of clinical practice in IVF. Medical experts in the field have advised the Company that the immediate benefits of metabolomic analysis are likely to include:
  1. enhanced treatment outcomes, and a reduction in the multiple birth rate
  2. a reduction in medical risk to mother and babies from multiple gestations,  resulting in reduced medical costs
  3. reduction in the time and cost of achieving a successful pregnancy
  4. enhanced quality of donor egg and sperm banks
  5. expansion of the IVF market as more couples can afford to seek treatment of infertility
  6. broader insurance coverage for IVF procedures
Preliminary Data:
Morphology versus Metabolomic Profile (MetPro) in Single Embryo Transfer (SET) Cycles Embryo reproductive potential was assessed by MetPro and morphology in the same embryo in D2 ,D3 and D5 transfers in SET cycles from 7 IVF programs. Calculations of the accuracy of Embryo Reproductive Potential (ERP) assessment were performed as described. Metabolomic profiling was more accurate than morphology in assessing embryo reproductive potential at each day of transfer in SET cycles.

day 2

day 3

day 5

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ViaMetrics-E
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