Merck KGaA’s (MKGAF) biopharma division, Merck Serono, announced that the FDA has granted clearance to Merck KGaA and partner Auxogyn’s Early Embryo Viability Assessment (Eeva) System.
The FDA provided this clearance through the de novo classification process. This process is applicable for low-to-moderate risk medical devices which are considered first-of-a-kind.
The Eeva Test, to be used adjunctively to traditional morphology, is a prognostic, non-invasive test conducted using proprietary software that analyzes embryo development against scientifically derived cell-division timing parameters captured through continual video imaging. This helps vitro fertilization (:IVF) clinicians to obtain objective information about the development of the embryo, thereby optimizing treatment plans for patients.
We note that in 2012, Auxogyn had received the CE mark for the Eeva System, which is currently available in the EU and Canada. In Apr 2014, Merck KGaA entered into a licensing agreement with Auxogyn to expand the availability of the Eeva Test in select markets. However, Auxogyn retains commercialization rights for the test in the U.S. and intends to commercialize it in late 2014.
According to the European Society of Human Reproduction and Embryology (:ESHRE), nearly 5 million babies have been born through assisted reproduction technologies (:ART) like IVF since 1978. Ferring’s Bravelle subcutaneous injection is approved for increasing the success of ART.
Merck KGaA carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. (GILD), Quintiles Transnational Holdings Inc. (Q) and ANI Pharmaceuticals, Inc. (ANIP). While Gilead and ANI Pharmaceuticals hold a Zacks Rank #1 (Strong Buy), Quintiles carries a Zacks Rank #2 (Buy).