Privately-held Switzerland-headquartered Ferring Pharmaceuticals and Swiss drug major Roche (ROG: SIX) have entered a collaboration to combine diagnostic testing technology from Roche with Ferring’s human cell line derived recombinant follicle-stimulating hormone (human rFSH), a gonadotrophin currently in Phase III development.
This combination is intended to make it possible for health care professionals to personalize infertility treatment to a woman’s specific needs. Under the terms of the worldwide agreement, Roche will work with Ferring and its global phase III programme to qualify, validate, document and seek regulatory approval for a companion diagnostic test to be used in combination with Ferring’s human rFSH.
Currently under development with Ferring’s human rFSH, the fully-automated Elecsys AMH assay from Roche aims to assess anti-Mullerian hormone (AMH) levels, a measure of a woman’s ovarian reserve and also of her ovarian response to infertility treatment with gonadotrophin. With this information, doctors will be better able to deliver a personalized dose of Ferring’s human rFSH based on the woman’s AMH level. Unlike manual AMH testing that can take up to several hours to produce results, the fully automated Elecsys AMH test determines hormone levels in 18 minutes, making it appropriate for routine clinical use.
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