15 February, 2017
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the European launch of its fully automated Elecsys® AMH Plus immunoassay, marking the result of its collaboration with Ferring Pharmaceuticals. The immunoassay, which is to be used for establishing an individualized daily dose of Ferring Pharmaceuticals’ human recombinant follicle-stimulating hormone REKOVELLE® (follitropin delta),1,2 is the first companion diagnostic to be approved for use in fertility.
An estimated 9% of women worldwide will experience infertility at some point in their lives.3 In some cases, medical treatment, including controlled ovarian stimulation (COS), as part of an assisted reproductive technology program, can help women conceive. Prior to treatment, diagnostic testing is often performed to shed light on a woman’s fertility potential and personalize her treatment needs.
Anti-Müllerian hormone (AMH) is a widely accepted biomarker used to predict a woman’s response to COS.4-6 By assessing serum AMH levels, clinicians can make informed treatment decisions to help maximise each woman’s chances of conception, while minimizing safety concerns such as ovarian hyperstimulation syndrome (OHSS).4-7
With a simple blood test, the fully-automated Elecsys® AMH Plus immunoassay can deliver precise and reliable results in 18 minutes from loading the serum sample,2,8-12 enabling clinicians to evaluate women quickly during their office visit, unlike manual tests, which can take up to several hours to produce results. The ease and speed of use make the Elecsys® AMH Plus immunoassay suitable for everyday clinical use.2,8-12
The launch of the Elecsys® AMH Plus follows the recent European Commission decision to grant marketing authorization for REKOVELLE® in COS for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilization (IVF)13 or intracytoplasmic sperm injection (ICSI) cycle.
With REKOVELLE®, Roche and Ferring have pioneered a new approach to dosing, which seeks to offer a personalised treatment option based on a woman’s serum AMH level and her body weight.1
About the Elecsys® AMH Plus immunoassay
The Elecsys® AMH Plus immunoassay has been shown to provide a precise, reliable and robust measurement of AMH levels.2,8-12 The fully automated Elecsys® AMH Plus immunoassay, run on the cobas e and Elecsys® immunoassay analysers, determines AMH levels in 18 minutes, making it appropriate for routine clinical use. The Elecsys® AMH Plus immunoassay is intended to be used for assessment of ovarian reserve, prediction of response to controlled ovarian stimulation (COS) and establishment of the individual daily dose of Ferring Pharmaceuticals’ follitropin delta in combination with body weight in COS for the development of multiple follicles in women undergoing an assisted reproductive technology program.2,8-12
About REKOVELLE® (follitropin delta)
REKOVELLE® (follitropin delta) from Ferring Pharmaceuticals is the first recombinant follicle stimulating hormone (FSH) derived from a human cell line.1,13-15 It has been developed for individualized dosing based on a woman’s serum anti-Müllerian hormone (AMH) level, as determined by a companion diagnostic, the Elecsys® AMH Plus immunoassay, and her body weight.1,2 Follitropin delta is structurally and biochemically distinct from other existing recombinant FSH treatments.1,13-16
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