2010-01-14

Abbott Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test


Abbott Park, Illinois (ots/PRNewswire) - A new diagnostictool, which studies show can aid in determining the risk of whether apelvic mass is benign or malignant, is now available in Europe. Thissimple blood test is expected to help in the assessment of epithelialovarian cancer, the most lethal form of gynecological cancer. Thisimportant immunoassay, which will run on Abbott's ARCHITECT systems,is the first automated HE4 test available anywhere in the world.

Research has shown that this novel diagnostic marker, combinedwith other tests such as the CA125 assay, can aid in measuring therisk of epithelial ovarian cancer in pre- and post-menopausal womenwho have a pelvic mass.

According to the International Agency for Research on Cancer, thefive-year survival rate of ovarian cancer patients is 46 percent.However, when the disease is diagnosed earlier, the survival rateincreases to 94 percent.

"The ability of this test to help physicians predict whether apelvic mass is benign or malignant is an important development forboth patients and physicians," said Michael Warmuth, senior vicepresident, diagnostics, Abbott. "Abbott's ARCHITECT HE4 test will aidphysicians in determining the most appropriate treatment for theirpatients."

Abbott partnered with Fujirebio Diagnostics, Inc. in thedevelopment of the assay. The test is now available in severalEuropean countries, as well as in some countries in Asia Pacific andLatin America. The ARCHITECT HE4 Assay was recently submitted to theFDA for 510(k) clearance.

About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologicalcancers and the fifth-leading cause of cancer death in women. Anestimated one in 72 women will develop ovarian cancer in herlifetime. It accounts for 31 percent of cancers of the female genitalorgans. Women who are postmenopausal are at the greatest risk forovarian cancer.

About Abbott Diagnostics

Abbott Diagnostics is a global leader in in vitro diagnostics andoffers a broad range of innovative instrument systems and tests forhospitals, reference labs, blood banks, physician offices andclinics. With more than 69,000 institutional customers in more than100 countries, Abbott's diagnostic products offer customersautomation, convenience, cost effectiveness and flexibility. Thehistory of Abbott Diagnostics is filled with examples offirst-of-a-kind products and significant technological advancements,including the development of the very first diagnostic test to detectHIV.

About Abbott

Abbott is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing ofpharmaceuticals and medical products, including nutritionals, devicesand diagnostics. The company employs more than 72,000 people andmarkets its products in more than 130 countries. Abbott's newsreleases and other information are available on the company's Website at www.abbott.com.

ots Originaltext: Abbott LaboratoriesIm Internet recherchierbar: http://www.presseportal.de

Contact:CONTACT: Media, Darcy Ross, +1-847-937-3655, or Financial, Tina Ventura,+1-847-935-9390, both of Abbott

Abbott Laboratories

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Abbott Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test

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