DiaSorin launches the hCG test for early detection of pregnancy on its LIAISON XL platform in the US market, completing its fertility panel offer .
September 24, 2013 - Saluggia (VC) - DiaSorin (FTSE MIB:DIA) is pleased to announce that it received the clearance for the LIAISON XL hCG test from the Food and Drug Administration (FDA) for the US market. The hCG test is an In Vitro Immunoassay for the quantitative determination of total human chorionic gonadotropin (hCG and βhCG) in human serum for early detection of pregnancy, which can be performed on the LIAISON XL Analyzer.
Human chorionic gonadotropin (hCG) is normally produced in significant amount only during pregnancy and it’s responsible of maintaining the function of the ovarian corpus luteum during the early weeks of pregnancy. In normal pregnancy, hCG concentrations rapidly increase at a rate that doubles approximately two days after fertilization. Pathologically decreased values indicate abnormal pregnancy (e.g. ectopic pregnancy). According to last estimates, the Fertility Diagnostic Laboratory testing value in the US market is around 100 million of US dollars, and certain tests such as hCG, increase not only for the use during early detection in pregnancy but also due to the infertility site request testing.
The launch of the new LIAISON XL hCG assay to the LIAISON menu, in addition to the other DiaSorin’s Fertility tests already approved by the FDA (LH, FSH, Prolactin, Progesterone, Estradiol, and Testosterone) completes the DiaSorin Fertility panel, and strengthens the menu offer in the US market. Furthermore it is strategic to position our LIAISON XL platform providing a complete, automatic and consolidated solution to our current and new potential clients, with a broader menu of tests in addition to the current DiaSorin US menu, covering different clinical areas’ needs, like Bone & Mineral, Infectious Disease, Hypertension, Diabetes and Thyroid. With the launch of hCG assay, the LIAISON DiaSorin’s menu in the US is made of 37 tests.
Carlo Rosa, Chief Executive Officer of DiaSorin Group, commented: “Our commitment to the expansion of our US menu is strong and every day more important. With the clearance received from the FDA on the hCG test on our LIAISON XL platform, we have completed our Fertility panel in the US market and we can continue strengthening our strategic positioning as the Diagnostic Specialist ”.