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GEN News Highlights : Aug 28, 2012

Testosterone Assay Approved in Europe

Abbott’s Architect 2nd Generation Testosterone Assay achieved CE mark certification in Europe, for the quantitative determination of testosterone levels in human serum and plasma. The assay is designed to sensitively measure even very low testosterone levels for the diagnosis of disorders including male hypogonadism, delayed or precocious puberty, and impotence in males, as well as female hirsutism, virilization due to tumors, polycystic ovaries, and androgenital syndromes.

Abbott claims the chemiluminescent microparticle immunoassay is more sensitive than existing testosterone assays that can’t measure very low levels of the hormone, and will facilitate the more accurate diagnosis of disease in patients suspected of having low-circulating testosterone.

The Architect 2nd Generation Testosterone Assay runs on the firm’s automated Architect family of analyzers, and has been approved and is available in a number of countries in Europe, Asia Pacific, Latin America, Japan, African, the Middle East, and India.