Roche Introduces New Fertility Test for Assessment of Ovarian Reserve for Pregnancy

PRESS RELEASE

Basel, 18 September 2014 -- Roche today announced the launch of the Elecsys Anti-Müllerian Hormone (AMH) blood test, the first fully-automated AMH test for assessing a woman’s ovarian reserve. AMH is an important fertility marker used by healthcare professionals to assess ovarian reserve levels. According to the WHO, fertility issues affect one in ten couples, up to 80 million people globallyi, and this number is rising.

The AMH blood test can be measured during any day of the menstrual cycle and is a superior indicator of ovarian reserve as compared to the follicle-stimulating hormone (FSH) and estradiol. In addition, the Elecsys AMH blood test produces standardized results for assessing ovarian reserve as compared with the use of ultrasound, in which the result is often dependent on the operator or clinic.

“The introduction of our Elecsys AMH test will enable healthcare professionals to incorporate AMH testing into routine clinical practice while getting more reliable results faster than conventional protocols and manual AMH assays. It is an important example of our focus on improving diagnostics in the area of women’s health”, stated Roland Diggelmann, Chief Operating Officer of Roche Diagnostics.

The Elecsys AMH blood test will be available in all markets accepting the CE mark in Europe, Latin America, Middle East, Africa and Asia. The test is currently not available in the United States and Japan.

In the future, the Elecsys AMH assay is also intended to be used in combination with the new human recombinant follicle-stimulating hormone (human rFSH) treatment currently in phase III development at Ferring Pharmaceuticals. This combination, which will make possible individualized dosing of human rFSH based on a woman’s specific AMH level, may provide an improved option for couples seeking to conceive through in vitro fertilization.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. 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.