Igenomix introduces EMBRACE, a non-invasive embryo test – validated in a recent study on 1,301 blastocysts, published in AJOG

A drop of the culture medium in which the embryo has developed provides chromosomal information from the embryo via EMBRACE, the new non-invasive chromosome test that Igenomix will be offering IVF centres from today.

This new launch by the Igenomix team is supported by the study entitled “Multicenter prospective study of concordance between embryo cell-free DNA and trophectoderm biopsies from 1,301 human blastocysts”, published in the latest edition of the international American Journal of Obstetrics & Gynecology, authored by Dr Rubio, Head of Embryo Genetic Research at Igenomix and her team.

The study analyzed embryos from more than 400 patients from 8 IVF centres across 4 continents. Each embryo was analyzed using invasive (trophectoderm DNA) and non-invasive methods (spent culture media), and the results compared, achieving concordance of around 80%.

More information about the embryo leads to more efficient and effective IVF treatment

In line with IVF centres resuming treatments, Igenomix is preparing to launch Embrace, which is set to significantly change current work practices. This new non-invasive embryo test will enable embryo chromosome analysis to be accessible to a larger number of IVF centres and patients, as it simplifies the process and removes the barrier of invasive embryo biopsy.

“Right now, with all treatments having been put on hold, time is more important than ever for patients. Non-invasive analysis can help us to discover more about embryo health and improve treatment efficiency, reducing the time it takes to get pregnant with the safest possible conditions for the embryo,” says Dr Rubio, lead author of the research.

Chromosomal abnormalities in embryos are responsible for a large number of IVF cycle failures and around 50% of miscarriages. “This new non-invasive diagnostic test will improve the chances of conceiving and achieving a full-term pregnancy, resulting in the birth of a healthy baby, which is our main goal in assisted reproduction,” says Professor Carlos Simón, Head of the Scientific Board of the Igenomix Foundation.

From the very first Preimplantation Genetic Testing for Aneuploidy (PGT-A) tests up to the present day, chromosomal analysis of the embryo has been carried out via an embryo biopsy. By identifying chromosomally normal embryos, PGT-A has improved the implantation rate in the first cycle and has reduced the miscarriage rate, as well as reducing the time it takes for an infertile couple to get pregnant.

This international, prospective multicentre study is the largest to date to validate a non-invasive approach. The study included culture media corresponding to 1,301 embryos from women undergoing PGT-A treatment at eight leading assisted-reproduction centres.

“The decision to analyze the culture media from embryos at day 6 of their development was a crucial part of this research. Analysis of the culture media of the same embryos at the latest stages of embryo development allowed us to optimize the results obtained, as the embryos contain a greater number of cells at day 6 and, therefore, release more DNA into the culture medium,” says Dr Rubio.

The results of this research show a 78% concordance rate between both diagnostic techniques – invasive (trophectoderm cells) and non-invasive (culture medium) for the same embryo. A further analysis of 81 aneuploid embryos, donated to the research and included in this study, showed an 84% concordance rate between the culture medium and the inner cell mass of the embryos (the cells of the preimplantation embryo that constitute the fetus in a pregnancy)  further reinforcing confidence in this approach.

Another improvement resulting from this research compared with previous studies is that the embryo analysis was conducted using Next Generation Sequencing (NGS) techniques, with a new Igenomix protocol and reporting algorithm, specifically designed for cell-free DNA analyses in culture media.

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