● The Elecsys® AMH Plus immunoassay is the first companion diagnostic to be approved for use in fertility
● This simple fertility blood test delivers results during consultation, helping clinicians incorporate AMH testing into routine patient management
● The launch is the result of a successful collaboration between Roche and Ferring Pharmaceuticals to enhance personalized medicine in fertility
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.
“Our collaboration with Ferring in the field of personalized healthcare reflects our ambition to provide differentiated solutions that help improve the lives of women,” says Jean-Claude Gottraux, Head of Centralized and Point of Care Solutions. “With the approval of our first companion diagnostic solution in the fertility treatment area, we are excited to continue pairing our technical expertise with industry partners to advance personalized healthcare across different therapeutic areas.”
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 maximize 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 sample2,8-12, 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 personalized treatment option based on a woman’s serum AMH level and her body weight.1
“As part of our commitment to innovation in reproductive health, we were looking for a partner that could support us in delivering biomarker-based personalization strategies to the fertility market,” commented Per Falk, MD, Executive Vice President and Chief Scientific Officer at Ferring Pharmaceuticals. “Collaborating with Roche, a global leader in diagnostics, we have developed a dosing regimen that enables doctors to tailor REKOVELLE® to each patient with the aim of maintaining efficacy while reducing complications during treatment.”
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 analyzers, 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
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
1. Nyboe Andersen A, et al. Efficacy and safety of follitropin delta in an individualised dosing regimen: A randomised, assessor-blind, controlled phase 3 trial in IVF/ICSI patients (ESTHER-1). Hum Reprod. 2016; 31:324
2. Roche Diagnostics. Elecsys® AMH (anti-Mullerian hormone) Plus immunoassay: Method sheet. 2016. Available at: https://pim-eservices.roche.com. Last accessed: January 2017.
3. Boivin J, et al. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod. 2007; 22(6):1506-12.
4. Nelson SM, et al. Anti-Müllerian hormone-based approach to controlled ovarian stimulation for assisted conception. Hum Reprod. 2009; 24(4):867–75.
5. La Marca A, et al. Anti-Mullerian hormone (AMH) as a predictive marker in assisted reproductive technology (ART). Hum Reprod Update. 2010; 16:113–130.
6. Fleming R, et al. Can anti-Mullerian hormone concentrations be used to determine gonadotropin dose and treatment protocol for ovarian stimulation? Reprod BioMed Online. 2013; 26:431–439
7. La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014; 20:124–140.
8. Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther. 2015; 19: 245-249.
9. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014; 52(8):1143-52.
10. Anderson RA, et al. Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015;103(4):1074–80.e4.
11. Nelson SM, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015; 104(4):1016-1021.e6.
12. Hyldgaard J, et al. Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol. 2015; 13(1):107.
13. Ferring Pharmaceuticals. Ferring Receives EU Approval For REKOVELLE® (follitropin delta). 2016 Available at: http://www.businesswire.com/news/home/20161213005883/en/Ferring-Receives-EU-Approval-REKOVELLE%C2%AE-follitropin-delta . Last accessed: January 2017.
14. World Intellectual Property Organization. World Intellectual Property Organization (WO 2009/127826 Al). Recombinant FSH including alpha 2,3 and alpha 2,6 sialylation. Available at: https://www.lens.org/images/patent/AU/2009237479/A1/20101111/AU_2009_237479_A1.pdf. Last accessed: January 2017.
15. World Health Organization (WHO). Available at: http://www.who.int/medicines/services/inn/56th_Executive_Summary.pdf. Last accessed: January 2017.
16. Olsson H, Sandström R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol 2014;54(11):1299–307.
17. Roche Market Book 2015, page 9
18. Roche Market Book 2015, page 53
19. Roche Market Book, 2015, page 212
20. Roche. Roche ranked most sustainable healthcare company in the Dow Jones Sustainability Index for the eighth year running. 2016. Available at http://www.roche.com/media/store/releases/med-cor-2016-09-08.htm. Last accessed: January 2017