Healthcare Professionals

The Eeva Test – First in Class and FDA-Cleared to Aid in Embryo Selection

Setting you and your patients up for success with the first clinically validated, non-invasive test for embryo development potential. Hopeful patients entrust their IVF team to make the right decisions to help them achieve a successful pregnancy. One of the most important – and most difficult – of these decisions is selecting the best embryos for transfer.

The Eeva Test utilizes proprietary software to automatically analyze embryo development against scientifically derived cell-division timing parameters captured continual time lapse video imaging and provide a result.

Prognostic Eeva Test results at Day 3 objectively identify embryos with High or Low probability of reaching the critical blastocyst stage when there are multiple embryos suitable for transfer.

Adding a new level of insight to optimize your patients’ treatment plans, Eeva Test results can be reviewed and shared with patients to help explain decisions made for embryo transfer.

The Eeva System – An Overview

Improve IVF Odds

The Eeva Test is founded on groundbreaking research licensed from Stanford University that identified non-invasive markers that would enable IVF clinicians to identify viable embryos early. Examining a wide range of potential markers and using gene expression data to assess embryo viability, it became clear that the markers with the greatest predictive power were precise patterns of cell division timing.. Among other significant discoveries, this research defined time lapse parameters P2 (time from 2-3 cell) and P3 (time from 3-to-4 cell) that predicted by Day 3 which embryos would successfully develop to the blastocyst stage. The findings, published in Nature Biotechnology , were recognized as a top 10 Medical Breakthrough by TIME magazine.

Clinically Validated Results, Across IVF Clinics

To receive FDA clearance, the Eeva Test was rigorously validated through a prospective, multi-center study.

The Eeva Prognostic Test was developed based on embryos cultured in 5 different clinics, each using their own culture condition to ensure generalizability of the prediction model. Then, the Eeva Test was validated against an independent dataset.

Auxogyn further demonstrated clinical utility of the Eeva Test through a study using a panel of 5 embryologists with varying backgrounds and experiences. The panel evaluated 758 embryos at Day 3 using traditional morphology grading alone, or morphology along with Eeva Test result. FDA accepted the results of this study which proved that the Eeva Test, when used adjunctively, was highly informative in identifying embryos that will develop to the blastocyst stage.

Click here for additional clinical information about the Eeva Test.
http://www.auxogyn.com/eeva-test/clinical-data/

The Eeva System – The Only Cleared Choice

The Eeva System is the first and only device cleared by the FDA to aid in embryo selection. As a novel technology, the Eeva System followed the FDA’s de novo pathway to clearance – a process used for first-of-a-kind, low-to-moderate risk devices. The FDA clearance resulted in creation of a new device classification with special controls to ensure safety, efficacy and performance across labs and operators.

Advancing the Field of IVF & Embryo Selection

  • Unprecedented access to non-invasive, prognostic test results
  • Reliable technology that meets the rigorous clinical standards of the FDA
  • Demonstrated safety, efficacy and performance across embryologists and labs
  • Powerful, objective insights to inform treatment plans and share with patients