Auxogyn Receives FDA Clearance for its Eeva System

Auxogyn Inc.’s first product, the Eeva System, has been cleared by the U.S. Food and Drug Administration (FDA) through the agency’s de novo classification process, a regulatory pathway for select novel, low- to moderate-risk medical devices. The Eeva System enables in vitro fertilization (IVF) clinicians to offer the Eeva Test, a prognostic, non-invasive assay that provides objective information regarding embryo development to help optimize treatment plans for their patients.

“We’re excited to receive the de novo FDA clearance for the Eeva System and believe this marks a significant milestone in the field of IVF,” said Lissa Goldenstein, president and CEO of Auxogyn. “We have followed a 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.”

Auxogyn is dedicated to advancing women’s reproductive health by translating scientific discovery into clinical solutions that may improve patient outcomes. The scientific foundation for its Eeva Test is based on research licensed from Stanford University. The Eeva Test utilizes proprietary software that automatically analyzes embryo development against scientifically derived cell-division timing parameters captured through continual video imaging.

Clearance of the Eeva Test was based on a multi-center, prospective clinical trial that clinically validated the test and found it to be informative in identifying embryos with the highest development potential, when used adjunctively after morphology.¹ Results of a study, where a panel of five embryologists adjunctively used the Eeva Test, showed that the odds of an embryo reaching the critical blastocyst stage at day 5/6 is 2.57 times higher among embryos predicted to become a blastocyst versus those predicted to not reach blastocyst stage.² Using the Eeva Test adjunctively to morphology, the odds ratio rose 53 percent over traditional, morphological grading.

“The Eeva Test represents a significant advancement in IVF that I believe will change the standard of care in our field,” explained G. David Adamson, M.D., reproductive endocrinologist and CEO of Advanced Reproductive Care, and past president of both the American Society of Reproductive Medicine (ASRM) and Society of Assisted Reproductive Technologies (SART). “With the Eeva Test, we now have information that when used adjunctively with traditional morphology provides us with more confidence in the embryo(s) we select for transfer, and more clinical information to share with our patients regarding their treatment plan.”

The Center for Disease Control reports that one out of eight U.S. couples is impacted by infertility, and 40 percent of them seek treatment, many through IVF. Only about one-third of IVF cycles result in live births, and nearly one third of live births are multiples.³

“With the IVF clinical community, we share the widely recognized goal to decrease the multiple birth rate without lowering the success rate,” Goldenstein said.

The Eeva System received CE Mark and has been commercially available in the European Union since 2012 and Canada since 2013. In April 2014, a licensing agreement was signed with Merck KGaA, Darmstadt, Germany, for the exclusive rights to commercialize the Eeva Test in Europe and Canada.

Auxogyn plans to commercialize the Eeva Test in the United States later this year.

Based in Menlo Park, Calif., Auxogyn is a women’s reproductive health firm based on early human developmental biology, computer technology, and clinical practices. The company is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech.

References:
¹ Conaghan et al, 2013
² Diamond et al, Automated time-lapse analysis in adjunctive use with morphology is highly informative in allowing diverse embryologists to select embryos with high developmental potential. Accepted for presentation at the European Society for Human Reproduction and Embryology Annual Meeting (2014).
³ CDC website http://www.cdc.gov/art/