A new frontier in IVF screening—noninvasive approaches to PGT-A
Robust, noninvasive methods to assess chromosomal copy numbers from embryo spent media (ESM) will expand accessibility of PGT-A while mitigating risks associated with embryo biopsy.
To support research towards this objective, we developed the Embgenix ESM Screen Kit and Embgenix Analysis Software to enable NGS-based detection of aneuploidies and mosaicisms from cfDNA in IVF embryo culture medium and/or blastocoel fluid. As demonstrated by the data below, the Embgenix ESM assay yields results concordant with copy number variation (CNV) calls from trophectoderm (TE)-biopsy-based analyses, but further R&D and clinical data is needed to refine the approach.
With this goal, we are seeking collaborators who can provide samples of spent embryo culture medium. We will process the samples at our San Jose, California facility with the Embgenix ESM Screen Kit to optimize and validate its performance compared to conventional TE-biopsy-based approaches. As part of our collaboration, you will receive first consideration for early access to our products as well as co-authorship on any resulting data presented at scientific conferences or in marketing content.
If you are interested in participating, please complete the form in the pop-up window on the right, and a member of our team will follow up with you shortly.
Comparison of Embgenix ESM assay and TE biopsy-based analysis
Figure 1. Comparison of Embgenix ESM assay vs. conventional PGT-A. CNV plots obtained from analysis of corresponding spent media and trophectoderm biopsy samples using the Embgenix ESM assay and VeriSeq PGS Kit, respectively. Panels A and B. Results indicating euploid status in embryo spent media and trophectoderm biopsy samples from the same IVF embryo, using Embgenix ESM (Panel A) and VeriSeq PGS (Panel B) assays, respectively. Panels C and D. Results indicating monosomy at chromosome 4 in an IVF embryo using Embgenix ESM (Panel C) and VeriSeq PGS (Panel D) assays.
| # of samples | Total chr concordance | Sex chr concordance | PPV | NPV | Sensitivity | Specificity | |
|---|---|---|---|---|---|---|---|
| Overall | 77 | 70% | 87% | 76% | 59% | 76% | 59% |
| Blastocoel fluid added | 41 | 76% | 79% | 88% | 58% | 75% | 78% |
| No blastocoel fluid added | 36 | 65% | 94% | 67% | 60% | 78% | 46% |
| With assisted hatching | 38 | 50% | 81% | 54% | 46% | 50% | 50% |
| No assisted hatching | 39 | 85% | 91% | 88% | 78% | 92% | 70% |
| No hatching (Stage 4) | 19 | 94% | 88% | 93% | 100% | 100% | 67% |
| Spontaneous hatching (Stage 5) | 20 | 76% | 94% | 80% | 71% | 80% | 71% |
Table 1. Assessment of embryo-handling effects on concordance of Embgenix ESM assay and conventional PGT-A. Spent culture media with/without blastocoel fluid and with/without assisted hatching was analyzed using the Embgenix ESM assay and compared to results obtained by conventional PGT-A.
| Day | Total chr concordance | Sex chr concordance | PPV | NPV | Sensitivity | Specificity |
|---|---|---|---|---|---|---|
| 5 | 79% | 79% | 89% | 60% | 80% | 75% |
| 6/7 | 90% | 100% | 88% | 100% | 100% | 67% |
Table 2. Assessment of sample collection timing on concordance of Embgenix ESM assay and conventional PGT-A. On the indicated days post-IVF, spent media samples were collected from embryos not subjected to assisted hatching and analyzed using the Embgenix ESM assay. TE-biopsy samples were analyzed by conventional PGT-A.
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