Ferring’s follicle-stimulating hormone is in development with a
companion diagnostic test from Roche to help improve the clinical
management of infertility treatment
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.1
“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
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
This unique approach in personalised medicine may provide an improved option for couples seeking to conceive through in vitro fertilization.
About the phase III clinical study
A multinational clinical phase III comparative study is already underway to confirm the efficacy and safety of Ferring’s human cell line derived rFSH in a personalised treatment regimen based on the woman’s AMH levels. The ESTHER (Evidence-based Stimulation Trial with Human rFSH in
Headquartered in Saint-Prex,
In 2013 the Roche Group employed over 85,000 people worldwide, invested
1 Gassner D, Jung R: First fully automated immunoassay for anti-MÜllerian hormone. Clin Chem Lab Med. 2014 Mar 13. pii: /j/cclm.ahead-of-print/cclm-2014-0022/cclm-2014-0022.xml. doi: 10.1515/cclm-2014-0022. [Epub ahead of print]
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