Ferring Pharmaceuticals and Roche have announced 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 healthcare professionals to personalise 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-Müllerian 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 personalised 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.
"The ability to tailor a specific dose of gonadotrophin based on a woman's personal AMH level would represent a major step forward in fertility management," said Pascal Danglas, MD, Executive Vice President, Clinical and Product Development at Ferring. "This collaboration demonstrates Ferring's commitment to researching and developing innovative treatment options for infertility."
Personalised dosing according to a woman's AMH level, if successful, may improve the predictability of infertility treatment and, as a result, lower the potential burden of treatment for women seeking to conceive through assisted reproductive technology.
"As a leader in personalised healthcare we are expanding this approach to ever more areas of unmet medical need such as infertility and women's health. In collaboration with Ferring, we are excited to play a pioneering role in individualising fertility management while continuing to invest in medically differentiated tests," said Jean-Claude Gottraux, Head of Roche Professional Diagnostics.
This unique approach in personalised medicine may provide an improved option for couples seeking to conceive through in vitro fertilization.
New guidelines developed for the diagnosis and management of premature ovarian insufficiency