In a development that is being hailed as a significant milestone in the field of in vitro fertilization, Auxogyn Inc. (Menlo Park, CA) has announced that its Eeva System test has received clearance from the FDA. The test is the first prognostic, non-invasive test that gives in vitro fertilization (IVF) clinicians objective information regarding embryo development to help them optimize treatment plans for their patients.
The Eeva Scope for the Eeva System. (Submitted image)
Lissa Goldenstein, president and CEO of Auxogyn, said in a press release, "We 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."
The Eeva Test is based on technology licensed from Stanford University. The test employs proprietary software that automatically analyzes embryo development against scientifically derived cell-division timing parameters captured through continual video imaging.
The study showed that through using the Eeva Test adjunctively to morphology, the odds ratio of an embryo reaching the critical blastocyst stage rose 53% over traditional morphological grading alone.
"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, MD, reproductive endocrinologist, 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 novel 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."
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FDA approved the Eeva System through its de novo classification process, a regulatory pathway for select novel, low- to moderate-risk medical devices for which, being first of a kind, there are no predicate devices. The Eeva System received the CE Mark and has been commercially available in the European Union since 2012, and in Canada since 2013. Auxogyn says that it plans to commercialize the Eeva System in the United States later this year.
