EMBRACE: Embryo Analysis of Culture Environment

Why use EMBRACE test?

• It avoids embryo biopsies and therefore reduces biopsy costs, making it accessible to a greater number of people.
• It does not require biopsy-trained embryologists, removing a barrier to offering aneuploidy analysis.
• A non-invasive solution for patients, giving them peace of mind and more effective treatment.

This new test is based on our recent study ‘Multicenter prospective study of concordance between embryo cell-free DNA and trophectoderm biopsies from 1,301 human blastocysts’ published in AJOG.

• This is the largest study to date assessing ploidy concordance per embryo between invasive and non-invasive PGT-A.
• The study had two main aims – to evaluate the concordance and reproducibility of testing embryo cell-free DNA versus trophectoderm DNA obtained from the same embryo in a large sample of day 6 and day 7 blastocysts, and to assess the concordance rates with the inner cell mass of the blastocyst in a subset of blastocysts donated for research.
• It is the only truly non-invasive protocol, without any previous manipulation of the embryo. No previous assisted hatching, biopsy or vitrification was permitted before media collection.
• Embryo cell-free DNA analysis shows high reliability in a multicentre study involving different culture and clinical conditions including: different patient clinical backgrounds, ovarian stimulation protocols, culture media, incubators and embryo quality.

The concordance rate was on average 78.2% (ranging from 72.5% to 86.3% in different centres), with no significant between-centre differences related to culture conditions or blastocyst quality.

In addition, in a subgroup of 81 blastocysts, comparison of the inner cell mass (ICM) with the embryo cell-free DNA in spent blastocyst medium (SBM) and the trophectoderm (TE) biopsies has shown similar concordance rates, 84.4% and 87.5% respectively.

• Currently, the concordance rate of this test with invasive biopsy procedures is 78.2%. Concordance means the chance that the non-invasive test results match with the results of embryo biopsy, though there is no guarantee that results from embryo biopsy are always correct. These data are from ongoing clinical trials currently in progress at Igenomix.
• The embryos never leave your clinic; the genetics laboratory only receives a sample of the culture medium in which the embryos have been grown. This liquid is considered waste and always disposed of once treatment has finished.
• The test is valid only when embryos have been grown to 6 or 7 days of age and are at the blastocyst stage.
• This test cannot be used to determine the gender of the embryo.
• On rare occasions, genetic testing cannot be carried out because of insufficient DNA in the culture media or poor-quality DNA.
• In some cases, additional genetic assessment may be needed, which might include an embryo biopsy.