Roche has launched 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 globally, 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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.