Fujirebio launches the automated Lumipulse® G AMH assay for accurate assessment of ovarian reserve

Product news

Gent, Belgium: April 26, 2019 - Fujirebio Europe announces the release of the Lumipulse G AMH assay for automated quantitative measurement of anti-Müllerian hormone in human serum or plasma. This new assay is an important extension of the Lumipulse G fertility panel of biomarkers, already including LH, FSH, Testosterone, Progesterone, Prolactine, Estradiol, and bHCG. Lumipulse G AMH is based on a two-step immunoassay method for the LUMIPULSE G System and uses fully automated unique cartridge CLEIA technology.

“Anti-Müllerian hormone is an important aid for the assessment of ovarian reserve and for the prediction of the response to therapy in controlled ovarian stimulation.” said Christiaan De Wilde, CEO of Fujirebio Europe. “It was very important for us to answer customer requests and make this key assay available on our LUMIPULSE G platform. Our customers can now access fast testing for a broad spectrum of fertility markers with their automated and mono cartridge concept-based platforms.” 
About anti-Müllerian hormone
Anti-Müllerian hormone (AMH) is a glycoprotein hormone and has key roles in growth differentiation and folliculogenesis:

  • In the male fetus, AMH is activated in the Sertoli cells. Its expression inhibits the development of the female reproductive tract, or Müllerian ducts, thereby arresting the development of fallopian tubes, uterus, and upper vagina.
  • In the adult female, AMH is a product of the granulosa cells in the ovary, from pre-antral and antral follicles. AMH regulates follicle recruitment by inhibiting recruitment of follicles from the resting pool.

Clinical interest of the AMH marker:

  • As an IVD marker, AMH is used for the assessment of the ovarian reserve.
  • Elevated levels of AMH are observed in patients with Polycystic Ovary Syndrome (PCOS) and patients with granulosa cell tumors.
  • AMH may be useful for diagnosis of (premature) menopause and evaluation of ovarian damage after surgery of endometriosis or chemotherapy.
  • AMH may be useful for the assessment of the gender in sex ambiguities.

About Fujirebio

Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.

Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.