Auxogyn has won CE mark approval for its non-invasive early embryo viability assessment (Eeva) test, designed to improve in vitro fertilisation (IVF) outcomes.
By utilising intelligent computer vision software, Eeva measures clinically validated cell-division parameters from video images as well as predicting blastocyst formation at the cleavage stage.
The CE mark approval is based on data from a prospective, multicentre, 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 analyse cell division timings with greater than 90% accuracy and was able to increase the consistency of embryo assessment across embryologists.
Lissa Goldenstein, Auxogyn president and chief executive officer, said Eeva provides clinically validated, consistent, objective and actionable information to identify those embryos which are the most appropriate for transfer.
"We are now able to bring clinically relevant discoveries to the field of assisted reproductive health by offering a tool that provides the objective data needed to improve decision-making and patient outcomes during embryo selection in the IVF process," Goldenstein added.
"We are prepared to begin our commercialisation efforts in the EU immediately to make Eeva available to infertility specialists and their patients.
"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 US"
Eeva, which is yet to be cleared by the FDA, is limited to investigational use only in the US, according to the company.