US-based Auxogyn and its strategic partner Merck Serono of Germany have received approval from the US Food and Drug Administration (FDA) for their new proprietary Early Embryo Viability Assessment (Eeva) system.
The Eeva Test is a prognostic, non-invasive embryo test that uses proprietary software to treat the syndrome.
The software automatically analyzes embryo development against the laboratory-derived cell-division timing parameters captured through continual video imaging.
By using this information, reproductive endocrinologists and embryologists can optimize treatment plans for patients.
Auxogyn president and CEO Lissa Goldenstein said they have followed a rigorous, years-long clinical validation process and regulatory pathway to bring the Eeva Test to market.
"Our clearance provides a new level of confidence to IVF clinicians who, for the first time, have quantitative information that can be used in addition to traditional morphology to aid in deciding which embryo or embryos to transfer," Goldenstein added.
Merck Serono strategy and global franchises head Meeta Gulyani said the FDA clearance of the Eeva System reinforces the value of the applicability of the Eeva Test in the IVF lab and may improve IVF outcomes.
"It marks another significant and exciting milestone in our continued collaboration with Auxogyn to further support the clinical development and commercialization of their Eeva Test," Gulyani added.
"We, therefore, welcome this further validation for the potential of the Eeva Test to objectively identify the embryos with the highest implantation potential, which may ultimately improve patient outcomes."
Merck Serono is the exclusive commercial partner of Auxogyn for the Eeva system in Europe and Canada.