Ferring and Roche Collaborate on Personalized Infertility Treatment

A rapid diagnostic hormone test from Roche will be used in developing personalized therapy with Ferring’s human cell line derived recombinant follicle-stimulating hormone (human rFSH), a gonadotrophin currently in phase III development.

Roche’s automated “Elecsys AMH” assay aims to assess anti-Müllerian hormone (AMH) levels, a measure of a woman’s ovarian reserve and 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. Also, unlike manual AMH testing that can take up to several hours to produce results, Elecsys AMH takes only 18 minutes, making it appropriate for routine clinical use.

This unique approach in personalized fertility medicine may provide a better treatment option. Personalized dosing according to a woman’s AMH level, if successful, may improve predictability of infertility treatment and, as a result, lower the potential burden of treatment for women and couples seeking to conceive through assisted reproductive technology.

Under the terms of the agreement, Roche will work with Ferring and its global phase III program to qualify, validate, document, and seek regulatory approval of a CDx test for Ferring’s human rFSH. A multinational clinical phase III comparative study is already underway. The ESTHER (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) program will enroll 1150 patients from 11 countries and from over 30 sites during 2014 and 2015 (additional studies are planned for US, Japan, China, and other parts of Asia).

“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.” Jean-Claude Gottraux, head of Roche Professional Diagnostics, said, “As a leader in personalized 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 individualizing fertility management while continuing to invest in medically differentiated tests.”

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