Rotkreuz / Switzerland, 06 January 2009
Roche Diagnostics announces CE launch of first diagnostic Preeclampsia Test
Roche Diagnostics announced today the CE launch of the first in vitro diagnostic tests for preeclampsia. The PlGF and sFlt-1 immunoassays have received CE approval for use on the Elecsys / cobas e electrochemiluminescense immunoassay systems.
Preeclampsia is a serious complication in pregnancy which affects both the mother and the unborn child. Women with Preeclampsia develop high blood pressure, protein in their urine and fluid retention. Preeclampsia occurs in at least 5 – 8% of all pregnancies and is a leading cause of preterm birth and consequent neonatal morbidity and mortality. Most cases of preeclampsia develop in healthy women bearing their first child and several medical conditions are associated with increased preeclampsia risk such as chronic hypertension, diabetes and renal disease. The condition is currently only detected after onset. “There is currently no early predictor of preeclampsia. The ability to identify women who should be monitored closely by their doctor and midwife would be of great value,” said James Creeden, Medical Director at Roche Professional Diagnostics.
Angiogenic growth factors such as Placenta Growth Factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) have been found to play a major role in the development of preeclampsia. PlGF is responsible for normal placental function and thereby maintenance of a healthy pregnancy, whereas sFlt-1 is associated with termination of pregnancy in the last weeks of gestation. Circulating levels of these proteins are altered in women who develop preeclampsia. Plasma levels of sFlt-1 are elevated in preeclampsia before the diagnosis and at time of clinical manifestation whereas PlGF levels are lower than in normal pregnancy. Therefore the combined ratio of sFlt-1/PlGF allows to discriminate normal pregnancy from preeclampsia syndrome.
“This test represents another important milestone for women’s health and we are proud to be the first to provide such innovative technology to clinicians and laboratories,” said Dirk Ehlers, Head of Roche Professional Diagnostics.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
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