Auxogyn has obtained CE mark approval for its non-invasive early embryo viability assessment (Eeva) test, designed to improve in vitro fertilization (IVF) outcomes.
By using intelligent computer vision software, Eeva test measures clinically validated cell-division parameters from video images as well as predicts blastocyst formation at the cleavage stage.
The CE mark approval is based on data from a prospective, multi-center, 160-patient clinical study, designed to assess the safety and efficacy of Eeva.
The results showed that Eeva was able to predict blastocyst formation at the cleavage stage with 85 % specificity, reducing the false positive rate from 43% to 15% compared with traditional morphology selection.
Eeva also showed the ability to track and analyze cell division timings with greater than 90% accuracy and was able to increase the consistency of embryo assessment across embryologists.
Auxogyn president and chief executive officer Lissa Goldenstein said Eeva provides clinically validated, consistent, objective and actionable information to identify those embryos which are the most appropriate for transfer.
"We are prepared to begin our commercialization efforts in the EU immediately to make Eeva available to infertility specialists and their patients," Goldenstein added.
"In addition, we have also recently submitted our 510(k) filing to the FDA in order to provide the benefits of Eeva to those in need in the U.S."